Spinal Cord Injuries
Conditions
Keywords
Ambulatory Disability, Disability Ambulation, Locomotion Disorders, Motor Activity, Rehabilitation, Spinal Cord Injury
Brief summary
The purpose of this study is to collect data comparing two means of providing locomotor training: manual and robotic and the possible differential effects it may have on walking ability for persons with spinal cord injury (SCI).
Detailed description
Spinal cord injury (SCI) is one of the most disabling health problems facing adults today, with one of the consequences often being inability to walk or difficulty walking. Recent studies suggest that intensive step training on a treadmill using body-weight support (BWS) and manual assistance that provides repetitive task-specific sensory cues to the neural axis can improve the recovery of walking for persons with incomplete SCI. More recently, robotics have been developed as an alternative to manually-assisted training. Robotic-assisted training may allow for increased intensity of training, improve the reproducibility and consistency of training, and reduce the personnel needed to implement the training. However, the effects of robotic-assisted training compared to manually-assisted training are not known. An improved understanding of these differential effects and the mechanisms of improvement in walking can facilitate continued advances in evidenced-based practice of neuro-rehabilitation, therefore improving the treatment of persons with SCI. The primary objective of this project is to assess and compare the effects of robotic-assisted versus manually-assisted locomotor training (LT) using the body-weight support (BWS) on sub-tasks of walking. Specifically, we believe that at least four sub-tasks of walking are differentially affected by the robotic-assisted training when compared to manually-assisted training (propulsion, transition from stance to step, stepping, and equilibrium). The investigators hypothesize that robotic-assisted training will have a greater effect on improving propulsion, transition and equilibrium. The effect of these two modalities on adaptability, a fifth sub-task of walking, is unclear; therefore, a development component of the pilot project will involve establishing a quantitative measure of adaptability and assessing differential effects of training. Participants will be randomized to one of two training groups: robotic-assisted or manually-assisted, and evaluated for performance on sub-tasks of walking.
Interventions
PROCEDUREManually Assisted Locomotor Training
The total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.
OTHERRobotic Assisted Locomotor Training
The total program is 45 sessions, 5x/week with total locomotor training (LT) duration of 30 stepping minutes/day. 1) BWS is initiated at 40% and gradually decreasing to 0%, 2) treadmill speed is set at normal walking speeds and increased as tolerated, and 3) manual assistance given when the subject is unable to independently step or control upright posture, and decreased as participant progresses. Trainers assist via verbal cues and manual assistance to achieve good stepping. The goal for endurance is 20 mins of continuous, independent, coordinated stepping on the treadmill at 0% BWS. Participants are encouraged to assist and/or independently maintain an upright posture, weight shift onto the loaded limb, flex or extend their legs, and to swing their arms in coordination with the legs.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults at least 18 years of age * Spinal cord injury (SCO) at least 6 months since injury * Motor I-SCI, upper motor neuron lesion only at cervical or thoracic levels * A diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology * SCI as defined by the American ASIA Impairment Scale categories C or D * Medically stable condition that is asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, contractures or other significant medical complications that would prohibit or interfere with testing of walking function and training or alter compliance with the training protocol * Documented medical approval from the participant's personal physician verifying the participant's medical status at time of enrollment * Ability to walk a minimum of 30 feet with or without an assistive device, independently or with minimal assistance * Over ground gait speed \< 0.8 m/s * Persons using anti-spasticity medication must maintain stable medication dosage during the study * Able to give informed consent
Exclusion criteria
* Current participation in a rehabilitation program/research protocol that could interfere or influence the outcome measures of the current study * History of congenital SCI (e.g. myelomeningocele, intraspinal neoplasm, Friedreich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration, syringomyelia) that may complicate the protocol * Inappropriate or unsafe fit of the harness or robotic trainer due to the participant's body size and/or joint contractures or severe spasticity that would prohibit the safe provision of either training modality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self Selected Velocity on Treadmill | 12 weeks | Subjects walk on a treadmill with overhead safety mounted to laboratory ceiling while wearing a harness. Treadmill speeds adjusted to lower than overground walking speeds and adjusted to patient reaches a comfortable speed. |
| Stepping: Foot Trajectory Toe-Off | 12 weeks | Foot angle in a global reference frame at the start of swing phase during treadmill walking at self-selected speed. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control). Stepping was quantified by the change in orientation of the foot angle (in a global reference frame) from the beginning to the end of the swing phase (i.e., foot-off to foot-down). The values will be identified from the processed 3-D kinematics for each walking cycle and average across steps. |
| Stepping: Foot Trajectory Toe-off % Cycle | 12 weeks | The outcome measure is the percentage of the gait cycle (%) for the occurrence of toe off. Foot trajectory toe-off was identified as indicated in the prior primary outcome (#2). The occurrence of toe-off was then identified relative to the percent of a complete gait cycle and thus the end point of the stance component of the gait cycle and the point of initiation for the swing component of the gait cycle. This outcome is reported in per cent of gait cycle. |
| Foot Trajectory Initial Contact | 12 weeks | Foot trajectory initial contact is the foot angle in a global reference frame at the end of swing (start of stance phase) during treadmill walking at self-selected speed when the foot contacts the ground (i.e. heel strike, foot contact, initial contact). The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e. deviation from the control mean divided by the SD among control). Foot trajectory initial contact (heel strike) was quantified by the orientation of the foot angle (in a global reference frame) at foot down (initial contact or heel strike). The values will be identified from the process 3-D kinematics for each walking cycle and averaged across steps. The outcome measurement is in degrees. |
| Foot Trajectory Range (Toe Off to Heel Strike) | 12 weeks | Range of foot trajectory from toe off to heel strike in degrees. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control). |
| Propulsion: Propulsive Impulse | 12 weeks | Push-off force at toe off in N-s during treadmill stepping |
| Kinematics: Minimum Thigh Angle | 12 weeks | Greatest thigh angle for hip flexion during stepping |
| Kinematics: Minimum Hip Angle - Extension | 12 weeks | Hip angle at maximal hip extension during stepping |
| Kinematics: Trunk Angle Mid-Stance | 12 weeks | Trunk Angle Mid-Stance - position in degrees |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred through James A. Haley Veterans' Hospital, Tampa, VA; North Florida/South Georgia Veterans Health System, Gainesville, FL; Paralyzed Veterans of America - Central Florida Chapter; Brooks Rehabilitation Hospital, Jacksonville, FL; Shands Rehab Hospital, Gainesville, FL; and the FL Brain and SCI Network.
Pre-assignment details
No significant events relative to enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Robotic Assisted Locomotor Training Robotic Assisted Locomotor Training - The total program was 45 sessions, 5x/week with total a locomotor training duration minimum of 30 stepping minutes/day.This occurred using a robotic device to provide assistance for stepping and standing kinematics with partial body weight support on a treadmill. | 8 |
| Manually Assisted Locomotor Training Manually Assisted Locomotor Training: The total program was 45 sessions, 5x/week with total a locomotor training duration minimum of 30 stepping minutes/day.This occurred on a treadmill with partial body weight support and manual assist from 3-4 trainers to produce stepping and standing kinematics. | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Robotic Assisted Locomotor Training | Manually Assisted Locomotor 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 | 8 Participants | 7 Participants | 15 Participants |
| Age, Continuous | 45.75 years STANDARD_DEVIATION 10.01 | 37.57 years STANDARD_DEVIATION 16.48 | 41.93 years STANDARD_DEVIATION 13.58 |
| Chronicity (months) | 18.81 months STANDARD_DEVIATION 15.97 | 23.21 months STANDARD_DEVIATION 24.84 | 20.87 months STANDARD_DEVIATION 19.92 |
| Lower Extremity Motor Score (X/50) | 40 units on a scale STANDARD_DEVIATION 9 | 37 units on a scale STANDARD_DEVIATION 13 | 38 units on a scale STANDARD_DEVIATION 10 |
| Overground walking self-selected velocity | 0.35 meters/sec STANDARD_DEVIATION 0.21 | 0.31 meters/sec STANDARD_DEVIATION 0.27 | 0.34 meters/sec STANDARD_DEVIATION 0.23 |
| Region of Enrollment United States | 8 participants | 7 participants | 15 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
| Walking of SCI II (x/20) | 12 units on a scale STANDARD_DEVIATION 4.41 | 12 units on a scale STANDARD_DEVIATION 4.84 | 12 units on a scale STANDARD_DEVIATION 4.41 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 9 | 7 / 10 |
| serious Total, serious adverse events | 0 / 9 | 1 / 10 |
Outcome results
Primary
Foot Trajectory Initial Contact
Foot trajectory initial contact is the foot angle in a global reference frame at the end of swing (start of stance phase) during treadmill walking at self-selected speed when the foot contacts the ground (i.e. heel strike, foot contact, initial contact). The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e. deviation from the control mean divided by the SD among control). Foot trajectory initial contact (heel strike) was quantified by the orientation of the foot angle (in a global reference frame) at foot down (initial contact or heel strike). The values will be identified from the process 3-D kinematics for each walking cycle and averaged across steps. The outcome measurement is in degrees.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted Locomotor Training | Foot Trajectory Initial Contact | Post-LT Foot Initial Contact HS | -2.99 degrees | Standard Deviation 3.15 |
| Robotic Assisted Locomotor Training | Foot Trajectory Initial Contact | Raw Post Foot Initial Contact HS | 0.5 degrees | Standard Deviation 11.56 |
| Robotic Assisted Locomotor Training | Foot Trajectory Initial Contact | Raw Pre Foot Contact Initial HS | 0.71 degrees | Standard Deviation 5.1 |
| Robotic Assisted Locomotor Training | Foot Trajectory Initial Contact | Standardized Pre-LT Foot Initial Contact HS | -2.57 degrees | Standard Deviation 1.55 |
| Manually Assisted Locomotor Training | Foot Trajectory Initial Contact | Post-LT Foot Initial Contact HS | -4.23 degrees | Standard Deviation 4.88 |
| Manually Assisted Locomotor Training | Foot Trajectory Initial Contact | Standardized Pre-LT Foot Initial Contact HS | -3.94 degrees | Standard Deviation 2.54 |
| Manually Assisted Locomotor Training | Foot Trajectory Initial Contact | Raw Pre Foot Contact Initial HS | -4.35 degrees | Standard Deviation 9.62 |
| Manually Assisted Locomotor Training | Foot Trajectory Initial Contact | Raw Post Foot Initial Contact HS | -4.87 degrees | Standard Deviation 18.96 |
p-value: 0.05t-test, 2 sided
Primary
Foot Trajectory Range (Toe Off to Heel Strike)
Range of foot trajectory from toe off to heel strike in degrees. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control).
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted Locomotor Training | Foot Trajectory Range (Toe Off to Heel Strike) | Standardized Pre-LT Foot Trajectory Range | 2.14 degrees | Standard Deviation 2.04 |
| Robotic Assisted Locomotor Training | Foot Trajectory Range (Toe Off to Heel Strike) | Standardized Post-LT Foot Trajectory Range | 3.12 degrees | Standard Deviation 3.22 |
| Robotic Assisted Locomotor Training | Foot Trajectory Range (Toe Off to Heel Strike) | Raw Pre-LT Foot Trajectory | -10.06 degrees | Standard Deviation 8.13 |
| Robotic Assisted Locomotor Training | Foot Trajectory Range (Toe Off to Heel Strike) | Raw Post-LT Foot Trajectory | -9.41 degrees | Standard Deviation 10.27 |
| Manually Assisted Locomotor Training | Foot Trajectory Range (Toe Off to Heel Strike) | Raw Post-LT Foot Trajectory | -30.73 degrees | Standard Deviation 19.3 |
| Manually Assisted Locomotor Training | Foot Trajectory Range (Toe Off to Heel Strike) | Standardized Pre-LT Foot Trajectory Range | -2.22 degrees | Standard Deviation 5.06 |
| Manually Assisted Locomotor Training | Foot Trajectory Range (Toe Off to Heel Strike) | Raw Pre-LT Foot Trajectory | -27.24 degrees | Standard Deviation 19.62 |
| Manually Assisted Locomotor Training | Foot Trajectory Range (Toe Off to Heel Strike) | Standardized Post-LT Foot Trajectory Range | -2.98 degrees | Standard Deviation 5.11 |
p-value: 0.05t-test, 2 sided
Primary
Kinematics: Minimum Hip Angle - Extension
Hip angle at maximal hip extension during stepping
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted Locomotor Training | Kinematics: Minimum Hip Angle - Extension | Standardized Pre-LT Minimum Hip Angle Extension | 0.11 degrees | Standard Deviation 2.46 |
| Robotic Assisted Locomotor Training | Kinematics: Minimum Hip Angle - Extension | Standarized Post-LT Min Hip Angle Extension | 0.74 degrees | Standard Deviation 2.26 |
| Robotic Assisted Locomotor Training | Kinematics: Minimum Hip Angle - Extension | Raw Pre-LT Min Hip Angle Extension | -0.09 degrees | Standard Deviation 12.74 |
| Robotic Assisted Locomotor Training | Kinematics: Minimum Hip Angle - Extension | Raw Post-LT Min Hip Angle Extension | 2.21 degrees | Standard Deviation 12.32 |
| Manually Assisted Locomotor Training | Kinematics: Minimum Hip Angle - Extension | Raw Post-LT Min Hip Angle Extension | -13.78 degrees | Standard Deviation 11.3 |
| Manually Assisted Locomotor Training | Kinematics: Minimum Hip Angle - Extension | Standardized Pre-LT Minimum Hip Angle Extension | -1.79 degrees | Standard Deviation 2.27 |
| Manually Assisted Locomotor Training | Kinematics: Minimum Hip Angle - Extension | Raw Pre-LT Min Hip Angle Extension | -9.8 degrees | Standard Deviation 11.54 |
| Manually Assisted Locomotor Training | Kinematics: Minimum Hip Angle - Extension | Standarized Post-LT Min Hip Angle Extension | -2.4 degrees | Standard Deviation 2.31 |
p-value: 0.05t-test, 2 sided
Primary
Kinematics: Minimum Thigh Angle
Greatest thigh angle for hip flexion during stepping
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted Locomotor Training | Kinematics: Minimum Thigh Angle | Raw Post-LT Thigh Angle Flexion | -7.23 degrees | Standard Deviation 9.04 |
| Robotic Assisted Locomotor Training | Kinematics: Minimum Thigh Angle | Standardized Post-LT Thigh Angle Flexion | 1.54 degrees | Standard Deviation 2.84 |
| Robotic Assisted Locomotor Training | Kinematics: Minimum Thigh Angle | Standardized Pre-LT Thigh Angle Flexion | 1.45 degrees | Standard Deviation 2.58 |
| Robotic Assisted Locomotor Training | Kinematics: Minimum Thigh Angle | Raw Pre-LT Thigh Angle Flexion | -6.9 degrees | Standard Deviation 8.24 |
| Manually Assisted Locomotor Training | Kinematics: Minimum Thigh Angle | Standardized Pre-LT Thigh Angle Flexion | -0.33 degrees | Standard Deviation 3.14 |
| Manually Assisted Locomotor Training | Kinematics: Minimum Thigh Angle | Raw Post-LT Thigh Angle Flexion | -17.05 degrees | Standard Deviation 8.22 |
| Manually Assisted Locomotor Training | Kinematics: Minimum Thigh Angle | Raw Pre-LT Thigh Angle Flexion | -12.4 degrees | Standard Deviation 9.77 |
| Manually Assisted Locomotor Training | Kinematics: Minimum Thigh Angle | Standardized Post-LT Thigh Angle Flexion | -1.71 degrees | Standard Deviation 2.64 |
p-value: 0.05t-test, 2 sided
Primary
Kinematics: Trunk Angle Mid-Stance
Trunk Angle Mid-Stance - position in degrees
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted Locomotor Training | Kinematics: Trunk Angle Mid-Stance | Standardized Pre-LT Trunk Angle Midstance | -1.41 degrees | Standard Deviation 2.93 |
| Robotic Assisted Locomotor Training | Kinematics: Trunk Angle Mid-Stance | Raw Pre-LT Trunk Angle Midstance | -10.79 degrees | Standard Deviation 10.12 |
| Robotic Assisted Locomotor Training | Kinematics: Trunk Angle Mid-Stance | Standardized Post-LT Trunk Angle Midstance | -1.84 degrees | Standard Deviation 2.93 |
| Robotic Assisted Locomotor Training | Kinematics: Trunk Angle Mid-Stance | Raw Post-LT Trunk Angle Mid-Stance | -9.73 degrees | Standard Deviation 11.78 |
| Manually Assisted Locomotor Training | Kinematics: Trunk Angle Mid-Stance | Raw Post-LT Trunk Angle Mid-Stance | -12.31 degrees | Standard Deviation 12.02 |
| Manually Assisted Locomotor Training | Kinematics: Trunk Angle Mid-Stance | Standardized Pre-LT Trunk Angle Midstance | -0.72 degrees | Standard Deviation 2.86 |
| Manually Assisted Locomotor Training | Kinematics: Trunk Angle Mid-Stance | Standardized Post-LT Trunk Angle Midstance | -0.72 degrees | Standard Deviation 2.86 |
| Manually Assisted Locomotor Training | Kinematics: Trunk Angle Mid-Stance | Raw Pre-LT Trunk Angle Midstance | -8.01 degrees | Standard Deviation 12.01 |
p-value: 0.05t-test, 2 sided
Primary
Propulsion: Propulsive Impulse
Push-off force at toe off in N-s during treadmill stepping
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted Locomotor Training | Propulsion: Propulsive Impulse | Standardized Pre-LT Propulsive Force | 1.51 N-s | Standard Deviation 2.77 |
| Robotic Assisted Locomotor Training | Propulsion: Propulsive Impulse | Standardized Post-LT Propulsive Force | 2.08 N-s | Standard Deviation 4.37 |
| Robotic Assisted Locomotor Training | Propulsion: Propulsive Impulse | Raw Pre-LT Propulsive Force | 9.06 N-s | Standard Deviation 3.75 |
| Robotic Assisted Locomotor Training | Propulsion: Propulsive Impulse | Raw Post-LT Propulsive Force | 8.48 N-s | Standard Deviation 3.75 |
| Manually Assisted Locomotor Training | Propulsion: Propulsive Impulse | Raw Post-LT Propulsive Force | 14.35 N-s | Standard Deviation 9.48 |
| Manually Assisted Locomotor Training | Propulsion: Propulsive Impulse | Standardized Pre-LT Propulsive Force | 7.76 N-s | Standard Deviation 7.23 |
| Manually Assisted Locomotor Training | Propulsion: Propulsive Impulse | Raw Pre-LT Propulsive Force | 15.97 N-s | Standard Deviation 8.02 |
| Manually Assisted Locomotor Training | Propulsion: Propulsive Impulse | Standardized Post-LT Propulsive Force | 7.12 N-s | Standard Deviation 8.17 |
p-value: 0.05t-test, 2 sided
Primary
Self Selected Velocity on Treadmill
Subjects walk on a treadmill with overhead safety mounted to laboratory ceiling while wearing a harness. Treadmill speeds adjusted to lower than overground walking speeds and adjusted to patient reaches a comfortable speed.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted Locomotor Training | Self Selected Velocity on Treadmill | Baseline Treadmill Walking Speed | 0.24 m/s | Standard Deviation 0.12 |
| Robotic Assisted Locomotor Training | Self Selected Velocity on Treadmill | Post-Intervention walking speed | 0.4 m/s | Standard Deviation 0.18 |
| Manually Assisted Locomotor Training | Self Selected Velocity on Treadmill | Post-Intervention walking speed | 0.39 m/s | Standard Deviation 0.17 |
| Manually Assisted Locomotor Training | Self Selected Velocity on Treadmill | Baseline Treadmill Walking Speed | 0.22 m/s | Standard Deviation 0.15 |
p-value: 0.05t-test, 2 sided
Comparison: Pearson correlation of gait speed changes with directional difference of standardized kinematic scores (i.e. foot trajectory toe-off - degrees, foot trajectory toe-off - % cycle, foot trajectory initial contact - degrees, foot trajectory range - degrees, propulsive impulse N-s, minimum thigh angle - flexion degrees, minimum hip angle - extension degrees, trunk angle mid-stance)p-value: 0.05Wilcoxon rank sum test
Primary
Stepping: Foot Trajectory Toe-Off
Foot angle in a global reference frame at the start of swing phase during treadmill walking at self-selected speed. The kinematic outcomes were first standardized as deviations from control subjects who walk at similar speed (i.e., deviation from the control mean divided by SD among control). Stepping was quantified by the change in orientation of the foot angle (in a global reference frame) from the beginning to the end of the swing phase (i.e., foot-off to foot-down). The values will be identified from the processed 3-D kinematics for each walking cycle and average across steps.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted Locomotor Training | Stepping: Foot Trajectory Toe-Off | Post-Intervention Standardized Toe Off | 3.56 degrees | Standard Deviation 1.83 |
| Robotic Assisted Locomotor Training | Stepping: Foot Trajectory Toe-Off | Post LT Raw Foot Trajectory Toe-Off | -22.46 degrees | Standard Deviation 11.44 |
| Robotic Assisted Locomotor Training | Stepping: Foot Trajectory Toe-Off | Baseline Standardized Toe Off | 2.58 degrees | Standard Deviation 1.2 |
| Robotic Assisted Locomotor Training | Stepping: Foot Trajectory Toe-Off | Baseline Raw Foot Trajectory Toe Off | -23.17 degrees | Standard Deviation 12.78 |
| Manually Assisted Locomotor Training | Stepping: Foot Trajectory Toe-Off | Post-Intervention Standardized Toe Off | -0.58 degrees | Standard Deviation 2.11 |
| Manually Assisted Locomotor Training | Stepping: Foot Trajectory Toe-Off | Baseline Raw Foot Trajectory Toe Off | -38.87 degrees | Standard Deviation 24.98 |
| Manually Assisted Locomotor Training | Stepping: Foot Trajectory Toe-Off | Post LT Raw Foot Trajectory Toe-Off | -53.52 degrees | Standard Deviation 18.77 |
| Manually Assisted Locomotor Training | Stepping: Foot Trajectory Toe-Off | Baseline Standardized Toe Off | 0.92 degrees | Standard Deviation 2.68 |
p-value: 0.05t-test, 2 sided
Primary
Stepping: Foot Trajectory Toe-off % Cycle
The outcome measure is the percentage of the gait cycle (%) for the occurrence of toe off. Foot trajectory toe-off was identified as indicated in the prior primary outcome (#2). The occurrence of toe-off was then identified relative to the percent of a complete gait cycle and thus the end point of the stance component of the gait cycle and the point of initiation for the swing component of the gait cycle. This outcome is reported in per cent of gait cycle.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Assisted Locomotor Training | Stepping: Foot Trajectory Toe-off % Cycle | Standardized Baseline Foot Toe Off % Cycle | -0.46 percentage of gait cycle | Standard Deviation 5.93 |
| Robotic Assisted Locomotor Training | Stepping: Foot Trajectory Toe-off % Cycle | Standardized Post-LT Toe off % cycle | -2.23 percentage of gait cycle | Standard Deviation 4.88 |
| Robotic Assisted Locomotor Training | Stepping: Foot Trajectory Toe-off % Cycle | Raw Pre Toe Off % cycle | 74.1 percentage of gait cycle | Standard Deviation 13.84 |
| Robotic Assisted Locomotor Training | Stepping: Foot Trajectory Toe-off % Cycle | Raw Post-LT Toe Off % cycle | 67.52 percentage of gait cycle | Standard Deviation 11.36 |
| Manually Assisted Locomotor Training | Stepping: Foot Trajectory Toe-off % Cycle | Raw Post-LT Toe Off % cycle | 75.38 percentage of gait cycle | Standard Deviation 9.22 |
| Manually Assisted Locomotor Training | Stepping: Foot Trajectory Toe-off % Cycle | Standardized Baseline Foot Toe Off % Cycle | 4.51 percentage of gait cycle | Standard Deviation 3.35 |
| Manually Assisted Locomotor Training | Stepping: Foot Trajectory Toe-off % Cycle | Raw Pre Toe Off % cycle | 85.66 percentage of gait cycle | Standard Deviation 8.06 |
| Manually Assisted Locomotor Training | Stepping: Foot Trajectory Toe-off % Cycle | Standardized Post-LT Toe off % cycle | 1.02 percentage of gait cycle | Standard Deviation 3.58 |
p-value: 0.05t-test, 2 sided