Incomplete Spinal Cord Injury
Conditions
Keywords
gait, locomotion, walking, balance, spinal cord injury, rehabilitation robotics
Brief summary
Spinal cord injury (SCI) affects \ 42,000 Veterans. The VA provides the single largest network of SCI care in the nation. The lifetime financial burden of SCI can exceed $3 million. A major cost of SCI is impaired mobility. Limited mobility contributes to decreased ability to work, increased care requirements, secondary injury, depression, bone mineral density loss, diabetes, and decreased cardiovascular health. Among ambulatory individuals with iSCI, residual balance deficits are common and are strongly correlated with both functional walking ability and participation in walking activities. The development of effective rehabilitation tools to improve dynamic balance would substantially improve quality of life for Veterans living with iSCI. Improving mobility through interventions that enhance dynamic balance would positively impact health, independence, and the ability to integrate into social, intellectual, and occupational environments.
Detailed description
Background: Among ambulatory individuals with incomplete spinal cord injury (iSCI), residual balance deficits are common and are a primary factor limiting participation in walking activities. There is broad recognition that effective evidence-based interventions are needed to enhance dynamic balance following iSCI. However, improving dynamic balance after iSCI has proven to be very challenging. Experimental interventions that amplify self-generated movements (e.g. error augmentation) may accelerate motor learning by intensifying sensory motor feedback and facilitating exploration of alternative motor control strategies. These features may be beneficial for retraining dynamic balance after iSCI. The investigators have developed a cable-driven robot to create a movement amplification environment during treadmill walking by applying a continuous viscous force field to the pelvis that is proportional in magnitude to a participant's real-time range of motion (ROM) velocity. The purpose is to investigate if locomotor training performed in a movement amplification environment can effectively improve dynamic balance and increase participation in walking activities of individuals with iSCI. Specific Aims: Aim 1: To evaluate if locomotor training performed in a movement amplification environment is effective for improving dynamic balance of individuals with iSCI. The investigators' pilot data found that following locomotor training performed in a movement amplification environment three individuals with iSCI each improved dynamic balance by more than 30%. These improvements were accompanied by faster over ground walking speeds and improved reactive balance. Thus, the investigators hypothesize that improvements in dynamic balance during walking will be greater when locomotor training is performed in a movement amplification environment when compared to locomotor training performed in a traditional treadmill environment. Aim 2: To evaluate the impact of locomotor training performed in either a movement amplification environment or in a traditional treadmill environment on participation in walking activities. Based on evidence identifying a strong relationship between balance and steps per day in ambulatory individuals with iSCI, the investigators hypothesize that training in the movement amplification environment will positively impact dynamic balance, and in turn increase participating in walking activities. Approach: The investigators will conduct a two-arm parallel-assignment intervention and will enroll 36 ambulatory participants with chronic motor incomplete spinal cord injury. Participants will be randomized into either a Control group receiving locomotor training or an Experimental group receiving locomotor training performed in a movement amplification environment. All participants will receive 20 training sessions. The investigators will assess changes in dynamic balance using measures that span the International Classification of Functioning, Disability and Health (ICF) framework including; 1) clinical outcome measures of gait, balance, and quality of life, 2) biomechanical assessments of the capacity to control center of mass (COM) motion during walking, and 3) data collected from activity monitors to quantify changes in participation in walking activities as evaluated by number of steps taken per day. Impact: Training dynamic balance of individuals with iSCI by amplifying their own self-generated center of mass motion during walking is a radical departure from current practice and may create effective new clinical strategies for addressing balance impairments of individuals with iSCI. Successful outcomes from the proposed trial would motivate development of clinically-feasible tools to first replicate and then to evaluate the movement amplification environment within the VA's clinical care settings. Knowledge gained from this study will expand the understanding of how individuals with iSCI learn dynamic balance and how targeted dynamic balance training impacts participation in walking activities.
Interventions
DEVICEGait training performed on a treadmill
Participants randomized to the Control group will complete high intensity gait training on a treadmill.
DEVICEGait training performed in a Movement Amplification Environment
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
Sponsors
Northwestern University
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Study personnel performing the clinical assessments will be blinded to the intervention.
Intervention model description
The investigators will conduct a two-arm parallel assignment intervention. Participants will be randomized into a high intensity locomotor training intervention that will be conducted in either a normal treadmill environment or in a movement amplification environment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Medically stable with medical clearance from a physician to participate * Neurologic level of the SCI between C1-T10 with American Spinal Injury Association (ASIA) Impairment Scale (AIS) C or D * \> 6 months since initial injury * Passive range of motion of the legs within functional limits and not restricting the ability to engage in locomotor training * Able to ambulatory 10m with no physical assistance, use of assistive devices (e.g. single cane, rolling walker), and/or braces that do not cross the knee joint (e.g. ankle foot orthosis) are permitted * Able to provide transportation to and from the testing location.
Exclusion criteria
* Excessive spasticity in the lower limbs as measured by a score of \> 3 on the Modified Ashworth Scale * Inability to tolerate 30 minutes of standing * Severe cardiovascular and pulmonary disease * History of recurrent fractures or known orthopedic problems in the lower extremities (i.e. heterotopic ossification) * Concomitant central or peripheral neurological injury (i.e. traumatic head injury or peripheral nerve damage in lower limbs) * Inability to provide informed consent due to cognitive impairments * Presence of unhealed decubiti or other skin compromise * Enrollment in concurrent physical therapy or research involving locomotor training * Use of braces/orthotics crossing the knee joint * Known pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Gait Assessment (FGA) | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The FGA is a ten-item test that evaluates dynamic balance and postural stability during gait. Each item on the test is scored from 0 (severe impairment) to 3 (normal ambulation). Total score of this test is 30, with higher score indicating better walking balance. Lowest possible score is 0. |
| Lateral Center of Mass Excursion | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average lateral center of mass excursion occurring each stride during treadmill walking. |
| Daily Stepping | Pre-training assessment (Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The investigators will assess the amount of daily stepping in the home and community during three 1-week periods. Daily stepping will be measured and recorded using an activity monitor. HIgher number of daily stepping indicates greater physical activity levels or greater walking in the community setting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance Evaluations Systems Test (BESTest) | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The BESTest is used to assess balance impairments across six different domains of postural control. We will use only the reactive balance item from the BESTest to assess changes in the capacity to react to fore-aft, and lateral perturbations. Each item will be scored on a range from 0 (severe impairment) to 3 (no impairment). Highest score is 6 and lowest possible score is 0. Higher score indicates better ability to restore balance and better reactive stepping response during standing perturbation. |
| Berg Balance Scale (BBS) | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The BBS is a 14-item measure that assesses static balance. Each item is scored on a range of 0 to 4. A total score is determined by summing scores on the all the individual items. Total score is 56. Higher score indicates better static balance. Lowest possible score is 0. |
| International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The ICIQ-UI SF is a 4-item self-report of urinary incontinence to document changes in bladder function. Scores range from 0-21, with greater values indicating increased severity. |
| Lower Extremity Motor Score | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The lower extremity motor score assess strength of five muscle groups representing neurological levels L2 to S1. Muscle function is grade on a range from 0 (total paralysis) to 5 (active movement, full range of motion (ROM) against gravity and sufficient resistance to be considered normal. Total score is 50. Higher score indicates better or more complete motor function in the lower extremities. Lowest possible score is 0. |
| Timed Up and Go (TUG) | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. The participant sits in a chair with his/her back against the chair back. On the command go, the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Time to complete the task is reported. Participant must use the same assistive device each time he/she is tested to be able to compare scores. |
| Walking Index for Spinal Cord Injury II (WISCI II) | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The WISCI II evaluates the amount of physical assistance needed for gait after spinal cord injury. The index ranges from 0 (client is unable to stand and/or participate in assisted walking) to 20 (ambulates with no devices, no braces and no physical assistance, 10 meters). Highest score is 20 and lowest possible score is 0. Higher score indicates better ability to ambulate at least a distance of 10 meters without assistance from assistive device and/or from other person. |
| The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The physical domain focuses on patients perception about his physical health including items related to mobility, daily activities, functional capacity, energy, pain, and sleep. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0. |
| 10 Meter Walk Test (10MWT)_Fast Speed | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The 10MWT is a simple measurement of an individuals average walking speed. |
| The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The social relations domain focuses on patients perception about their social connections, support, and sexual life, contributing to their overall quality of life. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0. |
| The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The environment domain focuses on patients perception about their surroundings, including factors like financial resources, safety, access to services, home environment, and the physical environment. social connections, support, and sexual life, contributing to their overall quality of life. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0. |
| Minimum Lateral Margin of Stability | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average minimum lateral margin of stability (distance between a velocity weighted whole body center of mass position and the edge of the base of support) occurring each step during treadmill walking. |
| Peak Lateral Center of Mass Speed | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average peak lateral center of mass speed occurring each stride during treadmill walking. |
| Step Width | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's preferred step width (lateral distance between calcaneal markers) during treadmill walking. |
| Step Length | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's preferred step length (anterior - posterior distance between calcaneal markers) during treadmill walking. |
| The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The psychological domain focuses on patients perception about their psychological well-being, encompassing aspects like self-image, negative and positive feelings, self-esteem, and mental status. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0. |
| 10 Meter Walk Test (10MWT)_Preferred Speed | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The 10MWT is a simple measurement of an individuals average walking speed. |
| Activities Specific Balance Confidence (ABC) Scale | Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline) | The ABC scale is a 16-item self-report measurement of an individual's confidence while performing numerous postural and ambulatory activities. Each item is rated on a scale of 0 (no confidence) to 100 (complete confidence). Overall score is calculated by adding item scores and then dividing by the total number of items. Total score is 100. Higher score indicates greater balance confidence i.e. ability to perform tasks with less or no fear of falling. Lowest possible score is 0. |
Countries
United States
Participant flow
Pre-assignment details
38 participants signed the consent form. Out of 38, 2 participants were excluded as they did not meet the inclusion criteria at in person screening and were not assigned to any group.
Participants by arm
| Arm | Count |
|---|---|
| Treadmill Group High Initial Function Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill in a natural environment without any forces applied (control group). | 18 |
| Movement Amplification Group High Initial Function The locomotor training protocol described for the Treadmill group and stratified into high initial function (who walk ≥0.5m/s without the use of any assistive device) will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.
Gait training performed in a Movement Amplification Environment: The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Treadmill Group High Initial Function | Movement Amplification Group High Initial Function | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 5 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 13 Participants | 24 Participants |
| Age, Continuous | 53.44 years STANDARD_DEVIATION 19.79 | 54.61 years STANDARD_DEVIATION 17.52 | 54.03 years STANDARD_DEVIATION 18.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 16 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 27 Participants |
| Time Since Injury | 10.56 years STANDARD_DEVIATION 14.96 | 7.94 years STANDARD_DEVIATION 8.83 | 9.25 years STANDARD_DEVIATION 12.18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 3 / 18 | 3 / 18 |
Outcome results
Primary
Daily Stepping
The investigators will assess the amount of daily stepping in the home and community during three 1-week periods. Daily stepping will be measured and recorded using an activity monitor. HIgher number of daily stepping indicates greater physical activity levels or greater walking in the community setting.
Time frame: Pre-training assessment (Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed. 1 participant's data not collected at Baseline but included in later assessment periods.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Treadmill Group | Daily Stepping | Pre-training assessment | 5,680 Average steps per day |
| Treadmill Group | Daily Stepping | Post-training assessment | 5,480 Average steps per day |
| Treadmill Group | Daily Stepping | Follow-up assessment | 6,041 Average steps per day |
| Movement Amplification Group | Daily Stepping | Pre-training assessment | 3,264 Average steps per day |
| Movement Amplification Group | Daily Stepping | Post-training assessment | 4,284 Average steps per day |
| Movement Amplification Group | Daily Stepping | Follow-up assessment | 3,530 Average steps per day |
Comparison: A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.p-value: 0.995% CI: [-651, 456]Mixed Models Analysis
Comparison: A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.p-value: 0.895% CI: [-622, 780]Mixed Models Analysis
Primary
Functional Gait Assessment (FGA)
The FGA is a ten-item test that evaluates dynamic balance and postural stability during gait. Each item on the test is scored from 0 (severe impairment) to 3 (normal ambulation). Total score of this test is 30, with higher score indicating better walking balance. Lowest possible score is 0.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Functional Gait Assessment (FGA) | Pre-training assessment | 15.22 score on a scale | Standard Deviation 7.82 |
| Treadmill Group | Functional Gait Assessment (FGA) | Mid-training assessment | 19.38 score on a scale | Standard Deviation 7.31 |
| Treadmill Group | Functional Gait Assessment (FGA) | Post-training assessment | 20.29 score on a scale | Standard Deviation 7.94 |
| Treadmill Group | Functional Gait Assessment (FGA) | Follow-up assessment | 20.57 score on a scale | Standard Deviation 8.08 |
| Movement Amplification Group | Functional Gait Assessment (FGA) | Follow-up assessment | 21.00 score on a scale | Standard Deviation 7.87 |
| Movement Amplification Group | Functional Gait Assessment (FGA) | Pre-training assessment | 14.22 score on a scale | Standard Deviation 7.61 |
| Movement Amplification Group | Functional Gait Assessment (FGA) | Post-training assessment | 19.88 score on a scale | Standard Deviation 7.64 |
| Movement Amplification Group | Functional Gait Assessment (FGA) | Mid-training assessment | 18.13 score on a scale | Standard Deviation 7.16 |
Comparison: A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant was used and fixed effects were time (assessment order) and a time by group interaction (Treadmill or Movement Amplification). A binomial distribution was used for this model.p-value: <0.00195% CI: [0.25, 0.55]Mixed Models Analysis
p-value: 0.895% CI: [-0.22, 0.16]Mixed Models Analysis
Comparison: A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.p-value: 0.595% CI: [-0.18, 0.36]Mixed Models Analysis
Comparison: A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.p-value: 0.695% CI: [-0.31, 0.17]Mixed Models Analysis
Primary
Lateral Center of Mass Excursion
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average lateral center of mass excursion occurring each stride during treadmill walking.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 35 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Lateral Center of Mass Excursion | Pre-training assessment | 10.16 centimeters | Standard Deviation 4.5 |
| Treadmill Group | Lateral Center of Mass Excursion | Mid-training assessment | 8.51 centimeters | Standard Deviation 3.75 |
| Treadmill Group | Lateral Center of Mass Excursion | Post-training assessment | 8.43 centimeters | Standard Deviation 4.35 |
| Treadmill Group | Lateral Center of Mass Excursion | Follow-up assessment | 8.73 centimeters | Standard Deviation 4.2 |
| Movement Amplification Group | Lateral Center of Mass Excursion | Follow-up assessment | 7.38 centimeters | Standard Deviation 1.73 |
| Movement Amplification Group | Lateral Center of Mass Excursion | Pre-training assessment | 9.82 centimeters | Standard Deviation 3.68 |
| Movement Amplification Group | Lateral Center of Mass Excursion | Post-training assessment | 7.19 centimeters | Standard Deviation 2.23 |
| Movement Amplification Group | Lateral Center of Mass Excursion | Mid-training assessment | 7.42 centimeters | Standard Deviation 2.39 |
Comparison: A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and time by group (Treadmill or Movement Amplification) interaction were usedp-value: 0.895% CI: [-0.5, 0.62]Mixed Models Analysis
Comparison: A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.p-value: 0.01295% CI: [-1.2, -0.16]Mixed Models Analysis
Comparison: A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.p-value: 0.395% CI: [-0.22, 0.75]Mixed Models Analysis
Comparison: A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.p-value: 0.495% CI: [-0.69, 0.29]Mixed Models Analysis
Secondary
10 Meter Walk Test (10MWT)_Fast Speed
The 10MWT is a simple measurement of an individuals average walking speed.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | 10 Meter Walk Test (10MWT)_Fast Speed | Pre-training assessment | 0.86 meter per second | Standard Deviation 0.51 |
| Treadmill Group | 10 Meter Walk Test (10MWT)_Fast Speed | Mid-training assessment | 1.14 meter per second | Standard Deviation 0.68 |
| Treadmill Group | 10 Meter Walk Test (10MWT)_Fast Speed | Post-training assessment | 1.15 meter per second | Standard Deviation 0.61 |
| Treadmill Group | 10 Meter Walk Test (10MWT)_Fast Speed | Follow-up assessment | 1.16 meter per second | Standard Deviation 0.64 |
| Movement Amplification Group | 10 Meter Walk Test (10MWT)_Fast Speed | Follow-up assessment | 1.09 meter per second | Standard Deviation 0.51 |
| Movement Amplification Group | 10 Meter Walk Test (10MWT)_Fast Speed | Pre-training assessment | 0.87 meter per second | Standard Deviation 0.52 |
| Movement Amplification Group | 10 Meter Walk Test (10MWT)_Fast Speed | Post-training assessment | 1.08 meter per second | Standard Deviation 0.48 |
| Movement Amplification Group | 10 Meter Walk Test (10MWT)_Fast Speed | Mid-training assessment | 1.01 meter per second | Standard Deviation 0.53 |
Secondary
10 Meter Walk Test (10MWT)_Preferred Speed
The 10MWT is a simple measurement of an individuals average walking speed.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | 10 Meter Walk Test (10MWT)_Preferred Speed | Pre-training assessment | 0.65 meter per second | Standard Deviation 0.4 |
| Treadmill Group | 10 Meter Walk Test (10MWT)_Preferred Speed | Mid-training assessment | 0.83 meter per second | Standard Deviation 0.45 |
| Treadmill Group | 10 Meter Walk Test (10MWT)_Preferred Speed | Post-training assessment | 0.83 meter per second | Standard Deviation 0.41 |
| Treadmill Group | 10 Meter Walk Test (10MWT)_Preferred Speed | Follow-up assessment | 0.84 meter per second | Standard Deviation 0.41 |
| Movement Amplification Group | 10 Meter Walk Test (10MWT)_Preferred Speed | Follow-up assessment | 0.81 meter per second | Standard Deviation 0.37 |
| Movement Amplification Group | 10 Meter Walk Test (10MWT)_Preferred Speed | Pre-training assessment | 0.65 meter per second | Standard Deviation 0.38 |
| Movement Amplification Group | 10 Meter Walk Test (10MWT)_Preferred Speed | Post-training assessment | 0.79 meter per second | Standard Deviation 0.35 |
| Movement Amplification Group | 10 Meter Walk Test (10MWT)_Preferred Speed | Mid-training assessment | 0.72 meter per second | Standard Deviation 0.38 |
Secondary
Activities Specific Balance Confidence (ABC) Scale
The ABC scale is a 16-item self-report measurement of an individual's confidence while performing numerous postural and ambulatory activities. Each item is rated on a scale of 0 (no confidence) to 100 (complete confidence). Overall score is calculated by adding item scores and then dividing by the total number of items. Total score is 100. Higher score indicates greater balance confidence i.e. ability to perform tasks with less or no fear of falling. Lowest possible score is 0.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: At post-training assessment, a total of 30 participants analyzed corresponds to those who completed intervention and post-training assessment. At follow up, a total of 28 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Activities Specific Balance Confidence (ABC) Scale | Pre-training assessment | 62.62 score on a scale | Standard Deviation 22.96 |
| Treadmill Group | Activities Specific Balance Confidence (ABC) Scale | Mid-training assessment | 71.97 score on a scale | Standard Deviation 22.94 |
| Treadmill Group | Activities Specific Balance Confidence (ABC) Scale | Post-training assessment | 73.50 score on a scale | Standard Deviation 25.46 |
| Treadmill Group | Activities Specific Balance Confidence (ABC) Scale | Follow-up assessment | 75.46 score on a scale | Standard Deviation 24.77 |
| Movement Amplification Group | Activities Specific Balance Confidence (ABC) Scale | Follow-up assessment | 77.32 score on a scale | Standard Deviation 15.89 |
| Movement Amplification Group | Activities Specific Balance Confidence (ABC) Scale | Pre-training assessment | 65.39 score on a scale | Standard Deviation 21.14 |
| Movement Amplification Group | Activities Specific Balance Confidence (ABC) Scale | Post-training assessment | 74.06 score on a scale | Standard Deviation 16.82 |
| Movement Amplification Group | Activities Specific Balance Confidence (ABC) Scale | Mid-training assessment | 75 score on a scale | Standard Deviation 16.32 |
Secondary
Balance Evaluations Systems Test (BESTest)
The BESTest is used to assess balance impairments across six different domains of postural control. We will use only the reactive balance item from the BESTest to assess changes in the capacity to react to fore-aft, and lateral perturbations. Each item will be scored on a range from 0 (severe impairment) to 3 (no impairment). Highest score is 6 and lowest possible score is 0. Higher score indicates better ability to restore balance and better reactive stepping response during standing perturbation.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Balance Evaluations Systems Test (BESTest) | Pre-training assessment | 2.64 units on a scale | Standard Deviation 1.98 |
| Treadmill Group | Balance Evaluations Systems Test (BESTest) | Mid-training assessment | 2.92 units on a scale | Standard Deviation 2.14 |
| Treadmill Group | Balance Evaluations Systems Test (BESTest) | Post-training assessment | 2.79 units on a scale | Standard Deviation 2.42 |
| Treadmill Group | Balance Evaluations Systems Test (BESTest) | Follow-up assessment | 3.14 units on a scale | Standard Deviation 2.35 |
| Movement Amplification Group | Balance Evaluations Systems Test (BESTest) | Follow-up assessment | 2.71 units on a scale | Standard Deviation 2.27 |
| Movement Amplification Group | Balance Evaluations Systems Test (BESTest) | Pre-training assessment | 1.88 units on a scale | Standard Deviation 1.71 |
| Movement Amplification Group | Balance Evaluations Systems Test (BESTest) | Post-training assessment | 2.40 units on a scale | Standard Deviation 2.23 |
| Movement Amplification Group | Balance Evaluations Systems Test (BESTest) | Mid-training assessment | 2.13 units on a scale | Standard Deviation 1.93 |
Secondary
Berg Balance Scale (BBS)
The BBS is a 14-item measure that assesses static balance. Each item is scored on a range of 0 to 4. A total score is determined by summing scores on the all the individual items. Total score is 56. Higher score indicates better static balance. Lowest possible score is 0.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Berg Balance Scale (BBS) | Pre-training assessment | 41.78 score on a scale | Standard Deviation 11.95 |
| Treadmill Group | Berg Balance Scale (BBS) | Mid-training assessment | 45.46 score on a scale | Standard Deviation 11.09 |
| Treadmill Group | Berg Balance Scale (BBS) | Post-training assessment | 46.79 score on a scale | Standard Deviation 9.68 |
| Treadmill Group | Berg Balance Scale (BBS) | Follow-up assessment | 47.43 score on a scale | Standard Deviation 9.21 |
| Movement Amplification Group | Berg Balance Scale (BBS) | Follow-up assessment | 48.64 score on a scale | Standard Deviation 8.98 |
| Movement Amplification Group | Berg Balance Scale (BBS) | Pre-training assessment | 41.67 score on a scale | Standard Deviation 13.78 |
| Movement Amplification Group | Berg Balance Scale (BBS) | Post-training assessment | 48.38 score on a scale | Standard Deviation 8.76 |
| Movement Amplification Group | Berg Balance Scale (BBS) | Mid-training assessment | 46.63 score on a scale | Standard Deviation 9.96 |
Secondary
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
The ICIQ-UI SF is a 4-item self-report of urinary incontinence to document changes in bladder function. Scores range from 0-21, with greater values indicating increased severity.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | Pre-training assessment | 4.43 score on a scale | Standard Deviation 5.2 |
| Treadmill Group | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | Mid-training assessment | 3.21 score on a scale | Standard Deviation 4.51 |
| Treadmill Group | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | Post-training assessment | 4.07 score on a scale | Standard Deviation 5.08 |
| Treadmill Group | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | Follow-up assessment | 3.71 score on a scale | Standard Deviation 4.7 |
| Movement Amplification Group | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | Follow-up assessment | 4.57 score on a scale | Standard Deviation 5.43 |
| Movement Amplification Group | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | Pre-training assessment | 4.19 score on a scale | Standard Deviation 5.36 |
| Movement Amplification Group | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | Post-training assessment | 4.31 score on a scale | Standard Deviation 5.31 |
| Movement Amplification Group | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) | Mid-training assessment | 3.63 score on a scale | Standard Deviation 4.6 |
Secondary
Lower Extremity Motor Score
The lower extremity motor score assess strength of five muscle groups representing neurological levels L2 to S1. Muscle function is grade on a range from 0 (total paralysis) to 5 (active movement, full range of motion (ROM) against gravity and sufficient resistance to be considered normal. Total score is 50. Higher score indicates better or more complete motor function in the lower extremities. Lowest possible score is 0.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Lower Extremity Motor Score | Pre-training assessment | 39.33 score on a scale | Standard Deviation 7.9 |
| Treadmill Group | Lower Extremity Motor Score | Follow-up assessment | 42 score on a scale | Standard Deviation 7.14 |
| Treadmill Group | Lower Extremity Motor Score | Mid-training assessment | 41.14 score on a scale | Standard Deviation 7.23 |
| Treadmill Group | Lower Extremity Motor Score | Post-training assessment | 41.71 score on a scale | Standard Deviation 7.22 |
| Movement Amplification Group | Lower Extremity Motor Score | Pre-training assessment | 40.39 score on a scale | Standard Deviation 6.06 |
| Movement Amplification Group | Lower Extremity Motor Score | Post-training assessment | 41.44 score on a scale | Standard Deviation 6.16 |
| Movement Amplification Group | Lower Extremity Motor Score | Mid-training assessment | 40.88 score on a scale | Standard Deviation 6.24 |
| Movement Amplification Group | Lower Extremity Motor Score | Follow-up assessment | 42 score on a scale | Standard Deviation 5.91 |
Secondary
Minimum Lateral Margin of Stability
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average minimum lateral margin of stability (distance between a velocity weighted whole body center of mass position and the edge of the base of support) occurring each step during treadmill walking.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 35 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Minimum Lateral Margin of Stability | Pre-training assessment | 5.84 centimeters | Standard Deviation 2.78 |
| Treadmill Group | Minimum Lateral Margin of Stability | Mid-training assessment | 6.16 centimeters | Standard Deviation 2.15 |
| Treadmill Group | Minimum Lateral Margin of Stability | Post-training assessment | 6.33 centimeters | Standard Deviation 2.39 |
| Treadmill Group | Minimum Lateral Margin of Stability | Follow-up assessment | 6.32 centimeters | Standard Deviation 2.94 |
| Movement Amplification Group | Minimum Lateral Margin of Stability | Follow-up assessment | 5.39 centimeters | Standard Deviation 3.42 |
| Movement Amplification Group | Minimum Lateral Margin of Stability | Pre-training assessment | 4.96 centimeters | Standard Deviation 2.4 |
| Movement Amplification Group | Minimum Lateral Margin of Stability | Post-training assessment | 4.73 centimeters | Standard Deviation 3.48 |
| Movement Amplification Group | Minimum Lateral Margin of Stability | Mid-training assessment | 5.0 centimeters | Standard Deviation 3.23 |
Secondary
Peak Lateral Center of Mass Speed
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average peak lateral center of mass speed occurring each stride during treadmill walking.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Peak Lateral Center of Mass Speed | Pre-training assessment | 0.25 centimeters per second | Standard Deviation 0.14 |
| Treadmill Group | Peak Lateral Center of Mass Speed | Mid-training assessment | 0.29 centimeters per second | Standard Deviation 0.13 |
| Treadmill Group | Peak Lateral Center of Mass Speed | Post-training assessment | 0.29 centimeters per second | Standard Deviation 0.15 |
| Treadmill Group | Peak Lateral Center of Mass Speed | Follow-up assessment | 0.29 centimeters per second | Standard Deviation 0.12 |
| Movement Amplification Group | Peak Lateral Center of Mass Speed | Follow-up assessment | 0.24 centimeters per second | Standard Deviation 0.1 |
| Movement Amplification Group | Peak Lateral Center of Mass Speed | Pre-training assessment | 0.22 centimeters per second | Standard Deviation 0.12 |
| Movement Amplification Group | Peak Lateral Center of Mass Speed | Post-training assessment | 0.27 centimeters per second | Standard Deviation 0.13 |
| Movement Amplification Group | Peak Lateral Center of Mass Speed | Mid-training assessment | 0.23 centimeters per second | Standard Deviation 0.1 |
Secondary
Step Length
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's preferred step length (anterior - posterior distance between calcaneal markers) during treadmill walking.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Step Length | Pre-training assessment | 0.27 meters | Standard Deviation 0.12 |
| Treadmill Group | Step Length | Mid-training assessment | 0.37 meters | Standard Deviation 0.15 |
| Treadmill Group | Step Length | Post-training assessment | 0.41 meters | Standard Deviation 0.17 |
| Treadmill Group | Step Length | Follow-up assessment | 0.39 meters | Standard Deviation 0.15 |
| Movement Amplification Group | Step Length | Follow-up assessment | 0.43 meters | Standard Deviation 0.14 |
| Movement Amplification Group | Step Length | Pre-training assessment | 0.28 meters | Standard Deviation 0.16 |
| Movement Amplification Group | Step Length | Post-training assessment | 0.45 meters | Standard Deviation 0.13 |
| Movement Amplification Group | Step Length | Mid-training assessment | 0.41 meters | Standard Deviation 0.11 |
Secondary
Step Width
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's preferred step width (lateral distance between calcaneal markers) during treadmill walking.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Step Width | Pre-training assessment | 0.27 meters | Standard Deviation 0.05 |
| Treadmill Group | Step Width | Post-training assessment | 0.26 meters | Standard Deviation 0.04 |
| Treadmill Group | Step Width | Mid-training assessment | 0.26 meters | Standard Deviation 0.04 |
| Treadmill Group | Step Width | Follow-up assessment | 0.26 meters | Standard Deviation 0.04 |
| Movement Amplification Group | Step Width | Mid-training assessment | 0.24 meters | Standard Deviation 0.06 |
| Movement Amplification Group | Step Width | Pre-training assessment | 0.26 meters | Standard Deviation 0.06 |
| Movement Amplification Group | Step Width | Follow-up assessment | 0.26 meters | Standard Deviation 0.06 |
| Movement Amplification Group | Step Width | Post-training assessment | 0.25 meters | Standard Deviation 0.06 |
Secondary
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The environment domain focuses on patients perception about their surroundings, including factors like financial resources, safety, access to services, home environment, and the physical environment. social connections, support, and sexual life, contributing to their overall quality of life. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment | Pre-training assessment | 80.50 score on a scale | Standard Deviation 19.4 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment | Mid-training assessment | 77.86 score on a scale | Standard Deviation 19.1 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment | Post-training assessment | 80.93 score on a scale | Standard Deviation 18.95 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment | Follow-up assessment | 84.00 score on a scale | Standard Deviation 16.82 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment | Follow-up assessment | 73.36 score on a scale | Standard Deviation 19.13 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment | Pre-training assessment | 79.44 score on a scale | Standard Deviation 16.65 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment | Post-training assessment | 77.06 score on a scale | Standard Deviation 19.72 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment | Mid-training assessment | 75.63 score on a scale | Standard Deviation 20.44 |
Secondary
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The physical domain focuses on patients perception about his physical health including items related to mobility, daily activities, functional capacity, energy, pain, and sleep. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical | Pre-training assessment | 74.29 score on a scale | Standard Deviation 18.56 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical | Mid-training assessment | 71.57 score on a scale | Standard Deviation 17.66 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical | Post-training assessment | 73.79 score on a scale | Standard Deviation 14.25 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical | Follow-up assessment | 73.79 score on a scale | Standard Deviation 20.02 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical | Follow-up assessment | 59.57 score on a scale | Standard Deviation 21.01 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical | Pre-training assessment | 62.63 score on a scale | Standard Deviation 18.44 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical | Post-training assessment | 65.06 score on a scale | Standard Deviation 23.31 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical | Mid-training assessment | 55.69 score on a scale | Standard Deviation 21.26 |
Secondary
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The psychological domain focuses on patients perception about their psychological well-being, encompassing aspects like self-image, negative and positive feelings, self-esteem, and mental status. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological | Pre-training assessment | 76.00 score on a scale | Standard Deviation 18.42 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological | Mid-training assessment | 75.93 score on a scale | Standard Deviation 12.87 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological | Post-training assessment | 78.07 score on a scale | Standard Deviation 10.62 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological | Follow-up assessment | 76.79 score on a scale | Standard Deviation 14.56 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological | Follow-up assessment | 65.64 score on a scale | Standard Deviation 20.87 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological | Pre-training assessment | 66.50 score on a scale | Standard Deviation 16.94 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological | Post-training assessment | 70.81 score on a scale | Standard Deviation 22.26 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological | Mid-training assessment | 64.19 score on a scale | Standard Deviation 22.81 |
Secondary
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The social relations domain focuses on patients perception about their social connections, support, and sexual life, contributing to their overall quality of life. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations | Pre-training assessment | 69.21 score on a scale | Standard Deviation 21.18 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations | Mid-training assessment | 66.07 score on a scale | Standard Deviation 18.7 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations | Post-training assessment | 65.46 score on a scale | Standard Deviation 17.47 |
| Treadmill Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations | Follow-up assessment | 71.43 score on a scale | Standard Deviation 18.48 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations | Follow-up assessment | 59.79 score on a scale | Standard Deviation 19.46 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations | Pre-training assessment | 60.56 score on a scale | Standard Deviation 25.28 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations | Post-training assessment | 57.81 score on a scale | Standard Deviation 25.41 |
| Movement Amplification Group | The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations | Mid-training assessment | 62.94 score on a scale | Standard Deviation 20.61 |
Secondary
Timed Up and Go (TUG)
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. The participant sits in a chair with his/her back against the chair back. On the command go, the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Time to complete the task is reported. Participant must use the same assistive device each time he/she is tested to be able to compare scores.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Timed Up and Go (TUG) | Pre-training assessment | 34.18 seconds | Standard Deviation 41.94 |
| Treadmill Group | Timed Up and Go (TUG) | Mid-training assessment | 21.49 seconds | Standard Deviation 24.4 |
| Treadmill Group | Timed Up and Go (TUG) | Post-training assessment | 23.59 seconds | Standard Deviation 35.11 |
| Treadmill Group | Timed Up and Go (TUG) | Follow-up assessment | 21.24 seconds | Standard Deviation 28.99 |
| Movement Amplification Group | Timed Up and Go (TUG) | Follow-up assessment | 24.67 seconds | Standard Deviation 28.59 |
| Movement Amplification Group | Timed Up and Go (TUG) | Pre-training assessment | 33.92 seconds | Standard Deviation 39.28 |
| Movement Amplification Group | Timed Up and Go (TUG) | Post-training assessment | 25.85 seconds | Standard Deviation 36.82 |
| Movement Amplification Group | Timed Up and Go (TUG) | Mid-training assessment | 27.51 seconds | Standard Deviation 32.55 |
Secondary
Walking Index for Spinal Cord Injury II (WISCI II)
The WISCI II evaluates the amount of physical assistance needed for gait after spinal cord injury. The index ranges from 0 (client is unable to stand and/or participate in assisted walking) to 20 (ambulates with no devices, no braces and no physical assistance, 10 meters). Highest score is 20 and lowest possible score is 0. Higher score indicates better ability to ambulate at least a distance of 10 meters without assistance from assistive device and/or from other person.
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Population: A total of 36 participants were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Group | Walking Index for Spinal Cord Injury II (WISCI II) | Pre-training assessment | 16.17 score on a scale | Standard Deviation 3.82 |
| Treadmill Group | Walking Index for Spinal Cord Injury II (WISCI II) | Mid-training assessment | 17.57 score on a scale | Standard Deviation 2.44 |
| Treadmill Group | Walking Index for Spinal Cord Injury II (WISCI II) | Post-training assessment | 18.00 score on a scale | Standard Deviation 2.29 |
| Treadmill Group | Walking Index for Spinal Cord Injury II (WISCI II) | Follow-up assessment | 18.21 score on a scale | Standard Deviation 2.01 |
| Movement Amplification Group | Walking Index for Spinal Cord Injury II (WISCI II) | Follow-up assessment | 17.21 score on a scale | Standard Deviation 4.1 |
| Movement Amplification Group | Walking Index for Spinal Cord Injury II (WISCI II) | Pre-training assessment | 14.89 score on a scale | Standard Deviation 4.65 |
| Movement Amplification Group | Walking Index for Spinal Cord Injury II (WISCI II) | Post-training assessment | 16.94 score on a scale | Standard Deviation 3.79 |
| Movement Amplification Group | Walking Index for Spinal Cord Injury II (WISCI II) | Mid-training assessment | 16.25 score on a scale | Standard Deviation 3.86 |