Trial Outcomes & Findings for Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury (NCT NCT02322125)

Results Overview

PCI is defined as the change in heart rate from the average at rest to the average in the last two minutes of the 6 minute walk test is divided by the average speed during the last two minutes of walking to give a measure of heartbeats/minute. The ratio between this measure while walking in the Rewalk and the same measure while performing the test using a wheelchair will be calculated. (Walk/wheelchair)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

End of training:12-14 weeks from baseline

Results posted on

2021-10-14

Participant Flow

Participants were recruited from May 2014 to September 26, 2018. Recruitment was through previous contacts, word of mouth and SCI Alberta newsletter.

Participant milestones

Participant milestones
Measure	ReWalk Training ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	ReWalk Training ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ReWalk Training n=11 Participants ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
Age, Continuous	37.5 years STANDARD_DEVIATION 13.7 • n=11 Participants
Sex: Female, Male Female	4 Participants n=11 Participants
Sex: Female, Male Male	7 Participants n=11 Participants
Region of Enrollment Canada	11 participants n=11 Participants

PRIMARY outcome

Timeframe: End of training:12-14 weeks from baseline

Population: Participants who completed 12 weeks of training intervention

PCI is defined as the change in heart rate from the average at rest to the average in the last two minutes of the 6 minute walk test is divided by the average speed during the last two minutes of walking to give a measure of heartbeats/minute. The ratio between this measure while walking in the Rewalk and the same measure while performing the test using a wheelchair will be calculated. (Walk/wheelchair)

Outcome measures

Outcome measures
Measure	ReWalk Training n=10 Participants ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
Physiological Cost Index (PCI) Ratio	3.34 unit less Standard Deviation 1.75

SECONDARY outcome

Timeframe: End of training (at 12 weeks for 10 participants and 6 weeks for 1) and at follow-up (2-3 months from end of training)

Population: All participants who completed \>6 weeks of training

Walking is timed over a 10 m section while the participant walks in the ReWalk in a 40 m hallway at the fastest safe speed possible.

Outcome measures

Outcome measures
Measure	ReWalk Training n=11 Participants ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
10 Meter Walk Test End of training	0.41 meters/second Standard Deviation 0.12
10 Meter Walk Test Follow-up	0.42 meters/second Standard Deviation 0.10

SECONDARY outcome

Timeframe: End of training:12-14 weeks from baseline

Population: Participants who completed 12 weeks of training

The maximum distance walked without a rest for up to one hour.

Outcome measures

Outcome measures
Measure	ReWalk Training n=10 Participants ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
Max Distance	1309 meters Standard Deviation 457

SECONDARY outcome

Timeframe: Baseline, Mid point-6 weeks from baseline, End training:12-14 weeks from baseline

Population: Participants able to sit unsupported at baseline and 12 weeks of training

While sitting/standing on a force plate, the participant will lean in 8 directions guided by a computer screen with feedback of the center of pressure. The sum of the maximum fore-aft and left right excursions was calculated. The changes from baseline to mid point of training, the end of the training phase (12 weeks) were calculated.

Outcome measures

Outcome measures
Measure	ReWalk Training n=10 Participants ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
Limits of Stability - Sitting Change at midpoint	1.6 cm Standard Deviation 2.6
Limits of Stability - Sitting Change at end of training	4.5 cm Standard Deviation 4.1

SECONDARY outcome

Timeframe: Baseline, Mid-point:6 weeks from baseline, End training:12-14 weeks from baseline

Population: Participants able to sit unsupported for greater than 22 seconds at baseline and after 12 weeks of training

Participants will sit on a force plate with feet unsupported, arms crossed over the chest and eyes closed. The trajectory of the center of pressure is measured for a maximum of 30 seconds or until balance is lost.

Outcome measures

Outcome measures
Measure	ReWalk Training n=8 Participants ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
Sitting Sway Change at midpoint	-1.59 cm/s Standard Deviation 1.85
Sitting Sway Change at end training	-1.38 cm/s Standard Deviation 1.38

SECONDARY outcome

Timeframe: Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline

Population: Participants with neuropathic pain at baseline

Paper/pencil questionnaire in which participant selects words that describe current pain. Words are divide into 20 subgroups and ranked within each group. A total score is tabulated by adding the number associated with the highest ranking word from each subgroup. Score range is from 0 to 73 with higher scores indicating greater pain.

Outcome measures

Outcome measures
Measure	ReWalk Training n=9 Participants ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
McGill Pain Questionnaire Baseline	14.4 score on a scale Standard Deviation 11.4
McGill Pain Questionnaire Midpoint	16.2 score on a scale Standard Deviation 11.7
McGill Pain Questionnaire End training	11.1 score on a scale Standard Deviation 5.6

SECONDARY outcome

Timeframe: Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline

Population: Participants measured weekly for 12 weeks. P1 and P2 were measured only at baseline, 6 weeks and 12 weeks of training. P5 withdrew after 6 weeks of training

Response to 3 standardized tests: stretch of ankle plantarflexors, pin prick to the sole of the foot, stretch of the hip and knee flexors scored from 1 to 3. The scores form both lower extremities were summed (total score: no spasticity = 0; maximum spasticity = 36

Outcome measures

Outcome measures
Measure	ReWalk Training n=8 Participants ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) Baseline	5.91 score on a scale Standard Deviation 6.17
Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) Midpoint	5.57 score on a scale Standard Deviation 4.35
Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) End training	6.25 score on a scale Standard Deviation 7.11

SECONDARY outcome

Timeframe: Baseline, End training:12-14 weeks from baseline

Population: Participants with adequate background emg

Single pulse transcranial magnetic stimulation is delivered over the vertex to induce motor evoked potentials in the back extensor muscles. Electrical responses in paraspinal muscles were recorded at 8 levels spanning the injury. The peak to peak amplitude of the response was averaged over rials with background muscle contraction of 10 to 40 microvolts

Outcome measures

Outcome measures
Measure	ReWalk Training n=7 Participants ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
Motor Evoked Potentials End training	353 microvolts Standard Deviation 118
Motor Evoked Potentials Baseline	402 microvolts Standard Deviation 193

SECONDARY outcome

Timeframe: Baseline, end training:12 -14 weeks from baseline

Population: Participants who completed 12 weeks of training

Five muscle groups in each lower extremity (hip flexors, knee extensors, ankle dorsiflexors, extensor of the big toe, and ankle plantarflexors) were tested as per the American Spinal Injury Association Impairment scale. Each muscle group was scored on a scale ranging from 0-5, where 0/5 indicates no muscle activity and is the lowest score and is considered to be a worse outcome. A score of 5/5 indicates normal strength and is considered the better outcome. The scores for all 10 muscle groups were summed so that the maximum score is 50. Change from baseline in Manual Muscle Test to end of training was calculated. 0= total paralysis 1. palpable or visible contraction 2. active movement, gravity eliminated 3. active movement, against gravity 4. active movement, against some resistance 5. active movement, against full resistance

Outcome measures

Outcome measures
Measure	ReWalk Training n=10 Participants ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs.
Change From Baseline in Manual Muscle Test at End of Training	0.4 units on a scale Standard Deviation 1.2

Adverse Events

ReWalk Training

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ReWalk Training n=12 participants at risk ReWalk exoskeleton training: 1.5 hr/day, 4 days/week, for 12-14 weeks (approximately 50 training sessions). Participants will progress through the following: sit-to-stand, stand-to-sit, standing balance and weight shift, walking on smooth ground, stopping, turning while walking, walking on rough ground, ascending and descending slopes, ascending and descending steps and curbs. ReWalk: Intensive training with the ReWalk to negotiate smooth ground, rough terrain indoors and outdoors, ascending and descending slopes and steps, in a home setting and in the community.
Skin and subcutaneous tissue disorders Skin abrasion	41.7% 5/12 • Number of events 12 • Adverse events were collected from baseline to end of training (12 to 14 weeks from baseline).

Additional Information

Dr. Jaynie Yang

University of Alberta

Phone: 780-492-2894

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place