Progressive Multiple Sclerosis
Conditions
Keywords
Robotics, Gait Training
Brief summary
The logistic advantages and advanced training capabilities of the G-EO System, as well as the benefits reported in other populations, support this strategy as a potentially potent rehabilitation tool for restoring and maintaining function in progressive Multiple Sclerosis (MS). This approach represents a paradigm shifting opportunity for improving current clinical practices for patients with progressive MS. If successful, this project will provide initial evidence for increasing patient access to the G-EO System, and this could be accomplished through regional technology centers using a rural health-delivery approach. There are several novel aspects of the proposed trial: (1) the examination of a novel gait rehabilitation stimulus (G-EO System) that could alter current clinical practices; (2) the focus on patients with progressive MS who have gait impairment (i.e., those who have received minimal research attention), which was recently described as the greatest therapeutic challenge facing the MS community; and (3) a study design that accounts for standard therapy. Specific Aims: The investigators designed a single-blinded, randomized pilot trial of electromechanically-assisted gait training using the G-EO System in patients with progressive MS with gait disability (EDSS=4.0-7.5). Specific Aim 1 will establish the safety and feasibility of gait training using the G-EO System. Specific Aim 2 will determine the efficacy of gait training using the G-EO System for improving mobility, symptomatic, quality of life, and participatory outcomes.
Interventions
DEVICEG-EO System (Reha Technology AG: Olten, Switzerland)
Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
OTHERConventional Physical Therapy
Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Sponsors
University of Alabama at Birmingham
University of Ottawa
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 18-64 years * Confirmed diagnosis of Primary or Secondary Progressive Multiple Sclerosis (this will be confirmed by the referring physician) * EDSS 4.0-7.522 * Stable course of disease-modifying therapy over the past 6 months * Asymptomatic (i.e., no underlying cardiovascular disease) * Physician approval for exercise * Willingness to visit the IU Health Neurosciences Center for testing and training
Exclusion criteria
* Pregnancy * Current use of dalfampridine (Ampyra®) * Conventional physical therapy or G-EO training within the past 6 months * Height \<1m or \>2m * Body weight \>150 kg * Contraindications to G-EO gait training (e.g., bone instability)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fast Walking Speed | Fast walking speed will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion. | Fast Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are able with the most common range being .5 to 2.0 meters per second. |
| Comfortable Walking Speed | Gait speed for comfortable walking will be assessed prior to the start of the treatment (Pretest) and following study completion which occurred following 20 treatment visits (Posttest) | Comfortable Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are comfortable with the most common range being .1 to 1.5 meters per second. |
| Two Minute Walk Test | Walking distance will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion. | A 2-minute walk (2MWT) test to determine walking endurance. Subjects will be asked to walk for 2 minutes along a 30m track. Subjects may stop and rest as often as needed. The outcome is the distance in meters traveled during the 2 minutes. Scores can range from 0 to 500 meters. An increase in distance following treatment when compared to pretest numbers would indicate improved muscular and cardiovascular endurance. |
| Modified Fatigue Impact Scale | Subjects perception of the their fatigue will be assessed prior to the start of the treatment and following study completion (at 10 weeks) | Subjects will complete a questionnaire evaluating their level of perceived fatigue. The scores are divided into three different scales: physical, cognitive, and psychosocial. A total score is also calculated. Scale scores are represented by the following ranges: physical subscale ranges from 0 to 36; cognitive subscale from 0 to 40; and psychosocial subscale from 0 to 8. A total score has a range of 0 to 85. A higher score indicates greater fatigue. Decreases in scores over time indicate decreases in feelings of fatigue. Each scale including the total score is summed. |
| Multiple Sclerosis Impact Scale-29 | Subjects perception of the their disability will be assessed prior to the start of the treatment and following study completion (at 10 weeks) | Subjects completed a 29 item questionnaire evaluating their level of health-related quality of life. The higher the score the greater the impact MS is having on their daily function. The 29 items are divided into a 20 item physical scale and 9 item psychological scale. Each item has four potential responses resulting in scores on the physical impact scale ranging from 20 to 80 and on the psychological impact scale ranging from 9 to 36. Final scores for each scale are achieved by summing the items for each of the two scales and then transforming them to a 100 point scale for easy comparison. On the 100 point scale, 0 would indicate no impact of the disease on daily function and 100 would indicate the greatest possible impact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form McGill Pain Questionnaire | Subjects perception of the their pain will be assessed prior to the start of the treatment and following study completion (at 10 weeks) | Subjects completed a questionnaire evaluating their level of pain. There are 15 adjectives that describe the patient's pain. The patient ranks each of the words on a categoric scale of none, mild, moderate, severe. Sensory and affective scores will be computed separately. Scores are created from a summary of the responses using an intensity scale of 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher the score the more severe the pain is for each of the subscales. For this study, sensory, affective, and total pain scores are reported. The minimum sensory, affective, and total score score would be zero. The maximum score for sensory is 33, affective is 12, and total is 45. |
| Late-Life Disability Inventory (LLFDI) | Subjects perception of the their functional ability using the total score and dimensional scores will be assessed prior to the start of the treatment and following study completion (at 10 weeks) | Subjects will complete a questionnaire evaluating their perceived level of disability. This tool assesses and responds to meaningful change in a persons disability (Ability to participate in life's activities). There is a 16 item disability component that is scored across two dimensions: frequency and limitation. Total scores and dimensional scores are created by summation and conversion to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. The lowest possible scale score is 0 and the highest score is 100 for both frequency and limitation. A higher score indicates greater functional ability and less disability. Each dimension can be further assessed by analyzing domains. There are social and personal domains within the frequency dimension and instrumental and management domains within the limitations dimension. All domains are calculated as described before through summation and scale adjustment. |
| Late-Life Function Inventory | Subjects perception of the their functional ability using all three domains will be assessed prior to the start of the treatment and following study completion (at 10 weeks) | Subjects will complete a questionnaire evaluating their perceived level of function. This tool assesses and responds to meaningful change in a persons function (ability to execute discrete tasks). There is a 32 item functional component is comprised of three domains Upper Extremity, Basic Lower Extremity, Advanced Lower Extremity. Total score and each domain will be scored by summing and then converting to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. A higher score indicates greater functional ability. The lowest score would be 0 and the highest scale score would be 100. |
| Hospital Anxiety and Depression Scale (HADS) | Subjects perception of the their anxiety and depression will be assessed prior to the start of the treatment and following study completion (at 10 weeks) | Subjects completed a questionnaire evaluating their level of anxiety and depression. The questionnaire is comprised of two scales: a 7 item scale related to anxiety and 7 item scale related to depression. Each item within both scales is scored using a 0-3 scoring system depending upon the individual's answer. Both the anxiety scale and the depression scale can range in scores from 0 to 21. Although the 14 items were administered together, each set of seven questions was kept separate and scored separately to create a score for anxiety and one for depression. The scores for each scale were summed to provide a total score for anxiety and a separate score for depression. The higher the score the greater the severity. A score between 8-10 is consider mild, 11-14 is moderate, \>14 is severe for both scales. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Physical Therapy Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training.40-43 Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
Conventional Physical Therapy: Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided. | 7 |
| End-Effector Robotic Training G-EO training: Using the G-EO System, participants will be secured with the appropriate sized harness and attached to an overhead body-weight support system, with feet secured to pressure sensitive footplates. Each session will begin with a 3-5 minute warm-up in the continuous passive mode (cadence \
40-45 steps/minute). The participant will then be transitioned into the adaptive training phase for practicing repetitive floor walking and stair climbing for up to 30 minutes. During this phase, the force produced by the robot is modulated to support the effort of the patient in producing a typical walking pattern.
G-EO System (Reha Technology AG: Olten, Switzerland): Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases. The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence. This system has the capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback. | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | Conventional Physical Therapy | End-Effector Robotic Training | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Continuous | 56.0 years STANDARD_DEVIATION 11.58 | 49.4 years STANDARD_DEVIATION 14.46 | 52.5 years STANDARD_DEVIATION 13.18 |
| Expanded Disability Status Scale (EDSS) | 6.0 units on a scale STANDARD_DEVIATION 0.33 | 5.81 units on a scale STANDARD_DEVIATION 0.88 | 5.9 units on a scale STANDARD_DEVIATION 0.74 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 7 participants | 8 participants | 15 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
Primary
Comfortable Walking Speed
Comfortable Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are comfortable with the most common range being .1 to 1.5 meters per second.
Time frame: Gait speed for comfortable walking will be assessed prior to the start of the treatment (Pretest) and following study completion which occurred following 20 treatment visits (Posttest)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Physical Therapy | Comfortable Walking Speed | Pretest Assessment (Prior to starting intervention training) | .45 meters per second | Standard Error 0.08 |
| Conventional Physical Therapy | Comfortable Walking Speed | Posttest Assessment (After completing intervention training) | .52 meters per second | Standard Error 0.9 |
| End-Effector Robotic Training | Comfortable Walking Speed | Pretest Assessment (Prior to starting intervention training) | .60 meters per second | Standard Error 0.137 |
| End-Effector Robotic Training | Comfortable Walking Speed | Posttest Assessment (After completing intervention training) | .67 meters per second | Standard Error 0.163 |
Comparison: Null hypothesis is no difference between the two groupsp-value: 0.405ANOVA
Comparison: Null hypothesis is no difference between pretest and posttestp-value: 0.133ANOVA
Comparison: Evaluated the difference between the pretest and posttest within the conventional physical therapy groupp-value: 0.05ANOVA
Comparison: Evaluating the impact of whether comfortable walking speed for both groups combined resulted in a significant improvement in walking speedp-value: 0.01795% CI: [0.015, 0.124]ANOVA
Primary
Fast Walking Speed
Fast Walking speed will be assessed using a Pressure Sensor Walkway. Participants will be asked to walk over a 14 foot pressure mat that will capture their walking speed. Scores range from 0 (no speed) to as fast as they are able with the most common range being .5 to 2.0 meters per second.
Time frame: Fast walking speed will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Physical Therapy | Fast Walking Speed | Pretest Assessment (Prior to intervention training) | .55 meters per second | Standard Error 0.108 |
| Conventional Physical Therapy | Fast Walking Speed | Posttest Assessment (following completion of intervention training) | .63 meters per second | Standard Error 0.131 |
| End-Effector Robotic Training | Fast Walking Speed | Pretest Assessment (Prior to intervention training) | .81 meters per second | Standard Error 0.19 |
| End-Effector Robotic Training | Fast Walking Speed | Posttest Assessment (following completion of intervention training) | .84 meters per second | Standard Error 0.205 |
Comparison: Null hypothesis is no difference between the two groupsp-value: 0.352ANOVA
Comparison: Within group assessmentp-value: 0.079ANOVA
Comparison: Within group assessmentp-value: 0.393ANOVA
Comparison: Evaluating the impact of whether fast walking speed for both groups combined resulted in a significant improvement in walking speedp-value: 0.04895% CI: [0.001, 0.116]ANOVA
Primary
Modified Fatigue Impact Scale
Subjects will complete a questionnaire evaluating their level of perceived fatigue. The scores are divided into three different scales: physical, cognitive, and psychosocial. A total score is also calculated. Scale scores are represented by the following ranges: physical subscale ranges from 0 to 36; cognitive subscale from 0 to 40; and psychosocial subscale from 0 to 8. A total score has a range of 0 to 85. A higher score indicates greater fatigue. Decreases in scores over time indicate decreases in feelings of fatigue. Each scale including the total score is summed.
Time frame: Subjects perception of the their fatigue will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Physical Therapy | Modified Fatigue Impact Scale | Pretest Total Score | 50.14 score on a scale | Standard Error 4.93 |
| Conventional Physical Therapy | Modified Fatigue Impact Scale | Posttest Cognitive Domain | 12.14 score on a scale | Standard Error 2.86 |
| Conventional Physical Therapy | Modified Fatigue Impact Scale | Posttest Total Score | 40.71 score on a scale | Standard Error 5.2 |
| Conventional Physical Therapy | Modified Fatigue Impact Scale | Pretest Physical Domain | 23.71 score on a scale | Standard Error 3.74 |
| Conventional Physical Therapy | Modified Fatigue Impact Scale | Posttest Physical Domain | 24.57 score on a scale | Standard Error 1.55 |
| Conventional Physical Therapy | Modified Fatigue Impact Scale | Pretest Cognitive Domain | 20.43 score on a scale | Standard Error 1.78 |
| Conventional Physical Therapy | Modified Fatigue Impact Scale | Pretest Psychological Domain | 6.0 score on a scale | Standard Error 0.436 |
| Conventional Physical Therapy | Modified Fatigue Impact Scale | Posttest Psychological Domain | 4.0 score on a scale | Standard Error 0.535 |
| End-Effector Robotic Training | Modified Fatigue Impact Scale | Pretest Physical Domain | 25.88 score on a scale | Standard Error 1.74 |
| End-Effector Robotic Training | Modified Fatigue Impact Scale | Pretest Cognitive Domain | 14.37 score on a scale | Standard Error 4.04 |
| End-Effector Robotic Training | Modified Fatigue Impact Scale | Posttest Cognitive Domain | 11.88 score on a scale | Standard Error 3.54 |
| End-Effector Robotic Training | Modified Fatigue Impact Scale | Posttest Psychological Domain | 2.88 score on a scale | Standard Error 0.766 |
| End-Effector Robotic Training | Modified Fatigue Impact Scale | Pretest Total Score | 43.75 score on a scale | Standard Error 4.61 |
| End-Effector Robotic Training | Modified Fatigue Impact Scale | Posttest Physical Domain | 19.50 score on a scale | Standard Error 2.33 |
| End-Effector Robotic Training | Modified Fatigue Impact Scale | Posttest Total Score | 34.25 score on a scale | Standard Error 4.87 |
| End-Effector Robotic Training | Modified Fatigue Impact Scale | Pretest Psychological Domain | 3.50 score on a scale | Standard Error 0.964 |
Comparison: Evaluation of the physical domainp-value: 0.594ANOVA
Comparison: Pretest- Posttest End Effector Robotic Training Comparison for the Physical Domainp-value: 0.061ANOVA
Comparison: Pretest posttest comparison of conventional training group for physical domainp-value: 0.812ANOVA
Comparison: Combined conventional and end-effector training for outcomes in the physical domainp-value: 0.235ANOVA
Comparison: Between group assessment of changes in the MFIS Cognitive domainp-value: 0.465ANOVA
Comparison: Within group differences for the End Effector Robotic Training Group for the Cognitive Domainp-value: 0.165ANOVA
Comparison: Within group assessment for the conventional group within the cognitive domain of the MFISp-value: 0.682ANOVA
Comparison: Combined group outcomes comparing pretest to posttest for the cognitive domainp-value: 0.01795% CI: [1.12, 9.67]ANOVA
Comparison: Between group comparison for the MFIS Psychological Subscalep-value: 0.052ANOVA
Comparison: Within group comparison for the end-effector robotic training group for the MFIS Psychological subscalep-value: 0.483ANOVA
Comparison: Within group assessment for the conventional physical therapy group for the MFIS Psychological subscalep-value: 0.056ANOVA
Comparison: Change in MFIS for all subjects from pre to posttest for the psychological subscalep-value: 0.04895% CI: [0.016, 2.619]ANOVA
Comparison: Between group assessment of differences in total scorep-value: 0.01ANOVA
Comparison: Within assessment of change in total fatigue scorep-value: 0.089ANOVA
Comparison: Within group assessment of change in total scorep-value: 0.5ANOVA
Comparison: Combined assessment of all subject improvement in total MFIS scorep-value: 0.195% CI: [2.678, 16.251]ANOVA
Primary
Multiple Sclerosis Impact Scale-29
Subjects completed a 29 item questionnaire evaluating their level of health-related quality of life. The higher the score the greater the impact MS is having on their daily function. The 29 items are divided into a 20 item physical scale and 9 item psychological scale. Each item has four potential responses resulting in scores on the physical impact scale ranging from 20 to 80 and on the psychological impact scale ranging from 9 to 36. Final scores for each scale are achieved by summing the items for each of the two scales and then transforming them to a 100 point scale for easy comparison. On the 100 point scale, 0 would indicate no impact of the disease on daily function and 100 would indicate the greatest possible impact.
Time frame: Subjects perception of the their disability will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Physical Therapy | Multiple Sclerosis Impact Scale-29 | Pretest Physical Subscale | 65.89 units on a scale | Standard Error 4.26 |
| Conventional Physical Therapy | Multiple Sclerosis Impact Scale-29 | Posttest Physical Subscale | 52.32 units on a scale | Standard Error 5.14 |
| Conventional Physical Therapy | Multiple Sclerosis Impact Scale-29 | Pretest Psychological Subscale | 55.16 units on a scale | Standard Error 3.12 |
| Conventional Physical Therapy | Multiple Sclerosis Impact Scale-29 | Posttest Psychological Subscale | 32.94 units on a scale | Standard Error 3.34 |
| End-Effector Robotic Training | Multiple Sclerosis Impact Scale-29 | Posttest Psychological Subscale | 26.39 units on a scale | Standard Error 7.84 |
| End-Effector Robotic Training | Multiple Sclerosis Impact Scale-29 | Pretest Physical Subscale | 47.97 units on a scale | Standard Error 7.97 |
| End-Effector Robotic Training | Multiple Sclerosis Impact Scale-29 | Pretest Psychological Subscale | 30.56 units on a scale | Standard Error 7.57 |
| End-Effector Robotic Training | Multiple Sclerosis Impact Scale-29 | Posttest Physical Subscale | 33.13 units on a scale | Standard Error 8.14 |
Comparison: Combined group comparison for the psychological subscale for the MSISp-value: 0.0004995% CI: [7.013, 19.38]ANOVA
Comparison: Null hypothesis set for no difference between groups Assessment of between group differences for the physical subscalep-value: 0.071ANOVA
Comparison: With group assessment of change on the physical subscale of the MSISp-value: 0.00595% CI: [6.02, 23.66]ANOVA
Comparison: With group assessment of change on the physical subscale of the MSISp-value: 0.00195% CI: [8.3, 18.85]ANOVA
Comparison: Combined group assessment of change on the physical subscale of the MSISp-value: 0.00002695% CI: [9.367, 19.04]ANOVA
Comparison: Between group comparison for the psychological subscale for the MSISp-value: 0.084ANOVA
Comparison: Within group comparison for the psychological subscale for the MSISp-value: 0.412ANOVA
Comparison: Within group comparison for the psychological subscale for the MSISp-value: 0.0001895% CI: [15.59, 28.85]ANOVA
Primary
Two Minute Walk Test
A 2-minute walk (2MWT) test to determine walking endurance. Subjects will be asked to walk for 2 minutes along a 30m track. Subjects may stop and rest as often as needed. The outcome is the distance in meters traveled during the 2 minutes. Scores can range from 0 to 500 meters. An increase in distance following treatment when compared to pretest numbers would indicate improved muscular and cardiovascular endurance.
Time frame: Walking distance will be assessed prior to the start of the treatment (Pretest) and following study completion (Posttest). Pretest represents a time point prior to intervention training. Posttest represents the point following intervention completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Physical Therapy | Two Minute Walk Test | Pretest Assessment (Prior to the start of intervention training) | 66.57 Meters | Standard Error 10.9 |
| Conventional Physical Therapy | Two Minute Walk Test | Posttest Assessment (Following completion of intervention training) | 72.62 Meters | Standard Error 14.23 |
| End-Effector Robotic Training | Two Minute Walk Test | Pretest Assessment (Prior to the start of intervention training) | 89.35 Meters | Standard Error 21.38 |
| End-Effector Robotic Training | Two Minute Walk Test | Posttest Assessment (Following completion of intervention training) | 93.21 Meters | Standard Error 19.14 |
Comparison: Comparison of the impact between the two arms looking an improved walking endurancep-value: 0.369ANOVA
Comparison: Evaluation of impact of end-effector robotic training alonep-value: 0.71ANOVA
Comparison: Evaluating the impact of conventional therapy on walking endurance Null hypothesis is no difference between pretest and posttestp-value: 0.682ANOVA
Comparison: Evaluating the impact of whether both groups combined resulted in a significant change in walking distancep-value: 0.568ANOVA
Secondary
Hospital Anxiety and Depression Scale (HADS)
Subjects completed a questionnaire evaluating their level of anxiety and depression. The questionnaire is comprised of two scales: a 7 item scale related to anxiety and 7 item scale related to depression. Each item within both scales is scored using a 0-3 scoring system depending upon the individual's answer. Both the anxiety scale and the depression scale can range in scores from 0 to 21. Although the 14 items were administered together, each set of seven questions was kept separate and scored separately to create a score for anxiety and one for depression. The scores for each scale were summed to provide a total score for anxiety and a separate score for depression. The higher the score the greater the severity. A score between 8-10 is consider mild, 11-14 is moderate, \>14 is severe for both scales.
Time frame: Subjects perception of the their anxiety and depression will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Physical Therapy | Hospital Anxiety and Depression Scale (HADS) | Pretest HADS Depression Score | 7.57 score on a scale | Standard Error 0.869 |
| Conventional Physical Therapy | Hospital Anxiety and Depression Scale (HADS) | Pretest HADS Anxiety Score | 8.43 score on a scale | Standard Error 1.445 |
| Conventional Physical Therapy | Hospital Anxiety and Depression Scale (HADS) | Posttest HADS Depression Score | 7.00 score on a scale | Standard Error 0.845 |
| Conventional Physical Therapy | Hospital Anxiety and Depression Scale (HADS) | Posttest HADS Anxiety Score | 7.14 score on a scale | Standard Error 1.223 |
| End-Effector Robotic Training | Hospital Anxiety and Depression Scale (HADS) | Posttest HADS Depression Score | 3.88 score on a scale | Standard Error 1.445 |
| End-Effector Robotic Training | Hospital Anxiety and Depression Scale (HADS) | Pretest HADS Depression Score | 4.75 score on a scale | Standard Error 1.187 |
| End-Effector Robotic Training | Hospital Anxiety and Depression Scale (HADS) | Posttest HADS Anxiety Score | 4.75 score on a scale | Standard Error 1.161 |
| End-Effector Robotic Training | Hospital Anxiety and Depression Scale (HADS) | Pretest HADS Anxiety Score | 5.88 score on a scale | Standard Error 1.076 |
Comparison: Between group assessment for the HADS Anxiety Subscalep-value: 0.117ANOVA
Comparison: Within group assessment for HADS Anxiety Subscalep-value: 0.04195% CI: [0.093, 3.407]ANOVA
Comparison: Within group assessment for HADS Anxiety Subscalep-value: 0.15ANOVA
Comparison: Combined group assessment of HADS Anxiety Subscalep-value: 0.01295% CI: [0.39, 2.646]ANOVA
Secondary
Late-Life Disability Inventory (LLFDI)
Subjects will complete a questionnaire evaluating their perceived level of disability. This tool assesses and responds to meaningful change in a persons disability (Ability to participate in life's activities). There is a 16 item disability component that is scored across two dimensions: frequency and limitation. Total scores and dimensional scores are created by summation and conversion to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. The lowest possible scale score is 0 and the highest score is 100 for both frequency and limitation. A higher score indicates greater functional ability and less disability. Each dimension can be further assessed by analyzing domains. There are social and personal domains within the frequency dimension and instrumental and management domains within the limitations dimension. All domains are calculated as described before through summation and scale adjustment.
Time frame: Subjects perception of the their functional ability using the total score and dimensional scores will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Physical Therapy | Late-Life Disability Inventory (LLFDI) | LLFDI Frequency Posttest | 49.78 score on a scale | Standard Error 2.74 |
| Conventional Physical Therapy | Late-Life Disability Inventory (LLFDI) | LLFDI Limitations Posttest | 56.00 score on a scale | Standard Error 2.78 |
| Conventional Physical Therapy | Late-Life Disability Inventory (LLFDI) | LLFDI Limitations Pretest | 52.72 score on a scale | Standard Error 1.79 |
| Conventional Physical Therapy | Late-Life Disability Inventory (LLFDI) | LLFDI Frequency Pretest | 50.10 score on a scale | Standard Error 2.13 |
| End-Effector Robotic Training | Late-Life Disability Inventory (LLFDI) | LLFDI Limitations Pretest | 60.27 score on a scale | Standard Error 2.73 |
| End-Effector Robotic Training | Late-Life Disability Inventory (LLFDI) | LLFDI Frequency Posttest | 54.93 score on a scale | Standard Error 2.57 |
| End-Effector Robotic Training | Late-Life Disability Inventory (LLFDI) | LLFDI Frequency Pretest | 55.21 score on a scale | Standard Error 2.38 |
| End-Effector Robotic Training | Late-Life Disability Inventory (LLFDI) | LLFDI Limitations Posttest | 62.44 score on a scale | Standard Error 2.99 |
Comparison: Between group assessment of LLFDI Disability Frequencyp-value: 0.136ANOVA
Comparison: Combined group assessment of improvement in LLFDI Disability Frequencyp-value: 0.833ANOVA
Comparison: Between Group Assessment of improvement in LLFDI Disability Limitationsp-value: 0.04495% CI: [0.212, 13.781]ANOVA
Comparison: Combined group assessment of improvement in LLFDI Disability Limitationsp-value: 0.212ANOVA
Secondary
Late-Life Function Inventory
Subjects will complete a questionnaire evaluating their perceived level of function. This tool assesses and responds to meaningful change in a persons function (ability to execute discrete tasks). There is a 32 item functional component is comprised of three domains Upper Extremity, Basic Lower Extremity, Advanced Lower Extremity. Total score and each domain will be scored by summing and then converting to a 100 point scaled score. The instrument provides a table for converting the raw score to a scaled score. A higher score indicates greater functional ability. The lowest score would be 0 and the highest scale score would be 100.
Time frame: Subjects perception of the their functional ability using all three domains will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Physical Therapy | Late-Life Function Inventory | LLDFI Function Pretest | 43.65 score on a scale | Standard Error 1.51 |
| Conventional Physical Therapy | Late-Life Function Inventory | LLFDI Function Posttest | 48.13 score on a scale | Standard Error 2.7 |
| End-Effector Robotic Training | Late-Life Function Inventory | LLDFI Function Pretest | 45.76 score on a scale | Standard Error 2.96 |
| End-Effector Robotic Training | Late-Life Function Inventory | LLFDI Function Posttest | 53.27 score on a scale | Standard Error 3.24 |
Comparison: Between group comparison for the LLDFI Functionp-value: 0.338ANOVA
Comparison: Within group assessment of LLFDI Functionp-value: 0.00795% CI: [2.73, 12.28]ANOVA
Comparison: Within group assessment for changes in LLFDI Functionp-value: 0.067ANOVA
Comparison: Combined group improvement in LLFDI Functionp-value: 0.00195% CI: [2.9, 9.08]ANOVA
Secondary
Short Form McGill Pain Questionnaire
Subjects completed a questionnaire evaluating their level of pain. There are 15 adjectives that describe the patient's pain. The patient ranks each of the words on a categoric scale of none, mild, moderate, severe. Sensory and affective scores will be computed separately. Scores are created from a summary of the responses using an intensity scale of 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher the score the more severe the pain is for each of the subscales. For this study, sensory, affective, and total pain scores are reported. The minimum sensory, affective, and total score score would be zero. The maximum score for sensory is 33, affective is 12, and total is 45.
Time frame: Subjects perception of the their pain will be assessed prior to the start of the treatment and following study completion (at 10 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Conventional Physical Therapy | Short Form McGill Pain Questionnaire | Pretest Total Pain | 12.71 score on a scale | Standard Error 4.057 |
| Conventional Physical Therapy | Short Form McGill Pain Questionnaire | Pretest Sensory Pain | 10.14 score on a scale | Standard Error 2.8 |
| Conventional Physical Therapy | Short Form McGill Pain Questionnaire | Pretest Affective Pain | 2.57 score on a scale | Standard Error 0.8 |
| Conventional Physical Therapy | Short Form McGill Pain Questionnaire | Posttest Affective Pain | 2.29 score on a scale | Standard Error 1.22 |
| Conventional Physical Therapy | Short Form McGill Pain Questionnaire | Posttest Total Pain | 11.14 score on a scale | Standard Error 4.114 |
| Conventional Physical Therapy | Short Form McGill Pain Questionnaire | Posttest Sensory Pain | 8.29 score on a scale | Standard Error 2.88 |
| End-Effector Robotic Training | Short Form McGill Pain Questionnaire | Pretest Affective Pain | 1.63 score on a scale | Standard Error 0.74 |
| End-Effector Robotic Training | Short Form McGill Pain Questionnaire | Pretest Total Pain | 6.63 score on a scale | Standard Error 2.89 |
| End-Effector Robotic Training | Short Form McGill Pain Questionnaire | Posttest Total Pain | 7.25 score on a scale | Standard Error 4.057 |
| End-Effector Robotic Training | Short Form McGill Pain Questionnaire | Pretest Sensory Pain | 5.00 score on a scale | Standard Error 2.62 |
| End-Effector Robotic Training | Short Form McGill Pain Questionnaire | Posttest Sensory Pain | 5.38 score on a scale | Standard Error 2.7 |
| End-Effector Robotic Training | Short Form McGill Pain Questionnaire | Posttest Affective Pain | 1.88 score on a scale | Standard Error 1.15 |
p-value: 0.239ANOVA
Comparison: Comparison between groups for differences in sensory pain scorep-value: 0.667ANOVA
Comparison: Between group differences in affective painp-value: 0.77ANOVA