Trial Outcomes & Findings for Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury (NCT NCT00127439)

Last Updated: 2018-01-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-01-24

Participant Flow

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.

No significant events relative to enrollment.

Participant milestones

Participant milestones
Measure	Robotic Assisted Locomotor Training A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.	Manually Assisted Locomotor Training A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.
Overall Study STARTED	9	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robotic Assisted Locomotor Training n=8 Participants 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.	Manually Assisted Locomotor Training n=7 Participants 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.	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.75 years STANDARD_DEVIATION 10.01 • n=5 Participants	37.57 years STANDARD_DEVIATION 16.48 • n=7 Participants	41.93 years STANDARD_DEVIATION 13.58 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants
Chronicity (months)	18.81 months STANDARD_DEVIATION 15.97 • n=5 Participants	23.21 months STANDARD_DEVIATION 24.84 • n=7 Participants	20.87 months STANDARD_DEVIATION 19.92 • n=5 Participants
Lower Extremity Motor Score (X/50)	40 units on a scale STANDARD_DEVIATION 9 • n=5 Participants	37 units on a scale STANDARD_DEVIATION 13 • n=7 Participants	38 units on a scale STANDARD_DEVIATION 10 • n=5 Participants
Walking of SCI II (x/20)	12 units on a scale STANDARD_DEVIATION 4.41 • n=5 Participants	12 units on a scale STANDARD_DEVIATION 4.84 • n=7 Participants	12 units on a scale STANDARD_DEVIATION 4.41 • n=5 Participants
Overground walking self-selected velocity	0.35 meters/sec STANDARD_DEVIATION 0.21 • n=5 Participants	0.31 meters/sec STANDARD_DEVIATION 0.27 • n=7 Participants	0.34 meters/sec STANDARD_DEVIATION 0.23 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Robotic Assisted Locomotor Training n=8 Participants Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.	Manually Assisted Locomotor Training n=7 Participants Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
Self Selected Velocity on Treadmill Baseline Treadmill Walking Speed	0.24 m/s Standard Deviation 0.12	0.22 m/s Standard Deviation 0.15
Self Selected Velocity on Treadmill Post-Intervention walking speed	0.4 m/s Standard Deviation 0.18	0.39 m/s Standard Deviation 0.17

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Robotic Assisted Locomotor Training n=8 Participants Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.	Manually Assisted Locomotor Training n=7 Participants Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
Stepping: Foot Trajectory Toe-Off Baseline Standardized Toe Off	2.58 degrees Standard Deviation 1.2	0.92 degrees Standard Deviation 2.68
Stepping: Foot Trajectory Toe-Off Post-Intervention Standardized Toe Off	3.56 degrees Standard Deviation 1.83	-0.58 degrees Standard Deviation 2.11
Stepping: Foot Trajectory Toe-Off Baseline Raw Foot Trajectory Toe Off	-23.17 degrees Standard Deviation 12.78	-38.87 degrees Standard Deviation 24.98
Stepping: Foot Trajectory Toe-Off Post LT Raw Foot Trajectory Toe-Off	-22.46 degrees Standard Deviation 11.44	-53.52 degrees Standard Deviation 18.77

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Robotic Assisted Locomotor Training n=8 Participants Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.	Manually Assisted Locomotor Training n=7 Participants Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
Stepping: Foot Trajectory Toe-off % Cycle Standardized Baseline Foot Toe Off % Cycle	-0.46 percentage of gait cycle Standard Deviation 5.93	4.51 percentage of gait cycle Standard Deviation 3.35
Stepping: Foot Trajectory Toe-off % Cycle Standardized Post-LT Toe off % cycle	-2.23 percentage of gait cycle Standard Deviation 4.88	1.02 percentage of gait cycle Standard Deviation 3.58
Stepping: Foot Trajectory Toe-off % Cycle Raw Pre Toe Off % cycle	74.1 percentage of gait cycle Standard Deviation 13.84	85.66 percentage of gait cycle Standard Deviation 8.06
Stepping: Foot Trajectory Toe-off % Cycle Raw Post-LT Toe Off % cycle	67.52 percentage of gait cycle Standard Deviation 11.36	75.38 percentage of gait cycle Standard Deviation 9.22

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Robotic Assisted Locomotor Training n=8 Participants Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.	Manually Assisted Locomotor Training n=7 Participants Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
Foot Trajectory Initial Contact Standardized Pre-LT Foot Initial Contact HS	-2.57 degrees Standard Deviation 1.55	-3.94 degrees Standard Deviation 2.54
Foot Trajectory Initial Contact Post-LT Foot Initial Contact HS	-2.99 degrees Standard Deviation 3.15	-4.23 degrees Standard Deviation 4.88
Foot Trajectory Initial Contact Raw Pre Foot Contact Initial HS	0.71 degrees Standard Deviation 5.1	-4.35 degrees Standard Deviation 9.62
Foot Trajectory Initial Contact Raw Post Foot Initial Contact HS	0.5 degrees Standard Deviation 11.56	-4.87 degrees Standard Deviation 18.96

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Robotic Assisted Locomotor Training n=8 Participants Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.	Manually Assisted Locomotor Training n=7 Participants Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
Foot Trajectory Range (Toe Off to Heel Strike) Standardized Pre-LT Foot Trajectory Range	2.14 degrees Standard Deviation 2.04	-2.22 degrees Standard Deviation 5.06
Foot Trajectory Range (Toe Off to Heel Strike) Standardized Post-LT Foot Trajectory Range	3.12 degrees Standard Deviation 3.22	-2.98 degrees Standard Deviation 5.11
Foot Trajectory Range (Toe Off to Heel Strike) Raw Pre-LT Foot Trajectory	-10.06 degrees Standard Deviation 8.13	-27.24 degrees Standard Deviation 19.62
Foot Trajectory Range (Toe Off to Heel Strike) Raw Post-LT Foot Trajectory	-9.41 degrees Standard Deviation 10.27	-30.73 degrees Standard Deviation 19.3

PRIMARY outcome

Timeframe: 12 weeks

Push-off force at toe off in N-s during treadmill stepping

Outcome measures

Outcome measures
Measure	Robotic Assisted Locomotor Training n=8 Participants Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.	Manually Assisted Locomotor Training n=7 Participants Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
Propulsion: Propulsive Impulse Standardized Pre-LT Propulsive Force	1.51 N-s Standard Deviation 2.77	7.76 N-s Standard Deviation 7.23
Propulsion: Propulsive Impulse Standardized Post-LT Propulsive Force	2.08 N-s Standard Deviation 4.37	7.12 N-s Standard Deviation 8.17
Propulsion: Propulsive Impulse Raw Pre-LT Propulsive Force	9.06 N-s Standard Deviation 3.75	15.97 N-s Standard Deviation 8.02
Propulsion: Propulsive Impulse Raw Post-LT Propulsive Force	8.48 N-s Standard Deviation 3.75	14.35 N-s Standard Deviation 9.48

PRIMARY outcome

Timeframe: 12 weeks

Greatest thigh angle for hip flexion during stepping

Outcome measures

Outcome measures
Measure	Robotic Assisted Locomotor Training n=8 Participants Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.	Manually Assisted Locomotor Training n=7 Participants Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
Kinematics: Minimum Thigh Angle Standardized Pre-LT Thigh Angle Flexion	1.45 degrees Standard Deviation 2.58	-0.33 degrees Standard Deviation 3.14
Kinematics: Minimum Thigh Angle Standardized Post-LT Thigh Angle Flexion	1.54 degrees Standard Deviation 2.84	-1.71 degrees Standard Deviation 2.64
Kinematics: Minimum Thigh Angle Raw Pre-LT Thigh Angle Flexion	-6.9 degrees Standard Deviation 8.24	-12.4 degrees Standard Deviation 9.77
Kinematics: Minimum Thigh Angle Raw Post-LT Thigh Angle Flexion	-7.23 degrees Standard Deviation 9.04	-17.05 degrees Standard Deviation 8.22

PRIMARY outcome

Timeframe: 12 weeks

Hip angle at maximal hip extension during stepping

Outcome measures

Outcome measures
Measure	Robotic Assisted Locomotor Training n=8 Participants Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.	Manually Assisted Locomotor Training n=7 Participants Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
Kinematics: Minimum Hip Angle - Extension Standardized Pre-LT Minimum Hip Angle Extension	0.11 degrees Standard Deviation 2.46	-1.79 degrees Standard Deviation 2.27
Kinematics: Minimum Hip Angle - Extension Standarized Post-LT Min Hip Angle Extension	0.74 degrees Standard Deviation 2.26	-2.4 degrees Standard Deviation 2.31
Kinematics: Minimum Hip Angle - Extension Raw Pre-LT Min Hip Angle Extension	-0.09 degrees Standard Deviation 12.74	-9.8 degrees Standard Deviation 11.54
Kinematics: Minimum Hip Angle - Extension Raw Post-LT Min Hip Angle Extension	2.21 degrees Standard Deviation 12.32	-13.78 degrees Standard Deviation 11.3

PRIMARY outcome

Timeframe: 12 weeks

Trunk Angle Mid-Stance - position in degrees

Outcome measures

Outcome measures
Measure	Robotic Assisted Locomotor Training n=8 Participants Robotic Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.	Manually Assisted Locomotor Training n=7 Participants Manually Assisted Locomotor Training - Individuals with chronic SCI, upper motor neuron lesions at cervical and thoracic levels, and able to walk 30 feet and over 0.8 m/sec walking velocity.
Kinematics: Trunk Angle Mid-Stance Standardized Pre-LT Trunk Angle Midstance	-1.41 degrees Standard Deviation 2.93	-0.72 degrees Standard Deviation 2.86
Kinematics: Trunk Angle Mid-Stance Standardized Post-LT Trunk Angle Midstance	-1.84 degrees Standard Deviation 2.93	-0.72 degrees Standard Deviation 2.86
Kinematics: Trunk Angle Mid-Stance Raw Pre-LT Trunk Angle Midstance	-10.79 degrees Standard Deviation 10.12	-8.01 degrees Standard Deviation 12.01
Kinematics: Trunk Angle Mid-Stance Raw Post-LT Trunk Angle Mid-Stance	-9.73 degrees Standard Deviation 11.78	-12.31 degrees Standard Deviation 12.02

Adverse Events

Robotic Assisted Locomotor Training

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Manually Assisted Locomotor Training

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Robotic Assisted Locomotor Training n=9 participants at risk A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.	Manually Assisted Locomotor Training n=10 participants at risk A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The therapist and trainers manually provide the appropriate kinematics associated with standing and stepping.
Blood and lymphatic system disorders Hospitalized	0.00% 0/9 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	10.0% 1/10 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Infections and infestations Hospitalized	0.00% 0/9 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	10.0% 1/10 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.

Other adverse events

Additional Information

Andrea L. Behrman, PhD, PT

University of Louisville

Phone: 502-582-7451

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Robotic Assisted Locomotor Training n=9 participants at risk A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.	Manually Assisted Locomotor Training n=10 participants at risk A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The therapist and trainers manually provide the appropriate kinematics associated with standing and stepping.
Vascular disorders Dizzy	11.1% 1/9 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	10.0% 1/10 • Number of events 2 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Skin and subcutaneous tissue disorders Skin abrasion	44.4% 4/9 • Number of events 6 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	40.0% 4/10 • Number of events 7 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Musculoskeletal and connective tissue disorders Loss of balance/fall	11.1% 1/9 • Number of events 2 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	10.0% 1/10 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	22.2% 2/9 • Number of events 3 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	20.0% 2/10 • Number of events 3 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Renal and urinary disorders Colored urine	11.1% 1/9 • Number of events 2 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	10.0% 1/10 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Gastrointestinal disorders Nausea	0.00% 0/9 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	20.0% 2/10 • Number of events 2 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Musculoskeletal and connective tissue disorders muscle pain groin	0.00% 0/9 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	10.0% 1/10 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Musculoskeletal and connective tissue disorders Muscle soreness (leg)	11.1% 1/9 • Number of events 2 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	0.00% 0/10 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Renal and urinary disorders Urinary tract infection	0.00% 0/9 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	10.0% 1/10 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
General disorders Headache	0.00% 0/9 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	10.0% 1/10 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	0.00% 0/10 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Infections and infestations Chills	0.00% 0/9 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	10.0% 1/10 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
General disorders Not feeling well	0.00% 0/9 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	10.0% 1/10 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
Musculoskeletal and connective tissue disorders Pulled back muscle	11.1% 1/9 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	0.00% 0/10 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.
General disorders Catheter loosens and comes off during training	11.1% 1/9 • Number of events 1 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.	0.00% 0/10 • 13 week total possible period for documentation of adverse events. During the 45 session period of daily locomotor training (5x/week for 9 consecutive weeks) and the one week of pre-testing and one week of post-testing, and up to two additional weeks of training if subject cancelled sessions for illness or otherwise. Systematic review of patient occurred for overall health/condition of skin, joints, health status at start and end of every session and throughout the training session.