Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

Restoring Walking With a Powered Exoskeleton After Complete and Sever Incomplete Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322125
• Other study ID #: Pro00036789
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: September 26, 2018

Study information

• Verified date: October 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Powered exoskeletons have emerged recently, promising to offer walking to individuals with severe spinal cord injury who are unable to walk. We will use the ReWalk exoskeleton to train walking in individuals with chronic, severe spinal cord injury (SCI). We will determine the characteristics of individuals who most benefit from such training, and identify the neuroplasticity induced by the training. We will further determine the feasibility of the ReWalk for home and community ambulation.

Description:

A prospective, pilot, cohort study design will recruit participants to train intensively for a 3 month period. The training sessions will be documented in detail, including number of steps taken, speed of walking, distance of walking. Once walking speed has plateaued, we will evaluate the feasibility of using the device in a home-like environment and in the community.

At the end of this study, we will have a good idea of the capability of the ReWalk to assist walking in those with severe spinal cord injury. We will better understand which individuals are most likely to benefit from the ReWalk. We will know how training in the ReWalk changes the neural connections between the brain and the spinal cord so that we can better guide the training protocol. Finally, we will identify limitations of the ReWalk for home and community use, so that exoskeletons can be improved in the future to maximize their benefit to people with spinal cord injury.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 26, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• non-progressive spinal cord injury =1 year post-injury

• Body height between 5'3" and 6'4"

• Body weight =82 kg

• Uses wheelchair as primary mode of mobility

• If able to walk, walks at =0.4 m/s

• Arm strength sufficient to control forearm crutches

• Agree to attend intensive training of 1.5 hr/day, 4 days/wk for 14 weeks, plus testing pre and post training of approximately 2 weeks each

Exclusion Criteria:

• Contractures at the hip, knee or ankle that interferes with fitting into the ReWalk

• Fractures within the last 2 years

• Osteoporosis in the legs (t-score =-3.0)

• Severe postural hypotension

• Severe spasticity that interferes with use of the ReWalk

• Active pressure sores

• Pregnancy

• Severe head injury

• Conditions that preclude intensive exercise (such as high blood pressure)

• Presence of conditions contraindicated for transcranial magnetic stimulation

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Khan AS, Livingstone DC, Hurd CL, Duchcherer J, Misiaszek JE, Gorassini MA, Manns PJ, Yang JF. Retraining walking over ground in a powered exoskeleton after spinal cord injury: a prospective cohort study to examine functional gains and neuroplasticity. J Neuroeng Rehabil. 2019 Nov 21;16(1):145. doi: 10.1186/s12984-019-0585-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological Cost Index (PCI) Ratio	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)	End of training:12-14 weeks from baseline
Secondary	10 Meter Walk Test	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.	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)
Secondary	Max Distance	The maximum distance walked without a rest for up to one hour.	End of training:12-14 weeks from baseline
Secondary	Limits of Stability - Sitting	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.	Baseline, Mid point-6 weeks from baseline, End training:12-14 weeks from baseline
Secondary	Sitting Sway	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.	Baseline, Mid-point:6 weeks from baseline, End training:12-14 weeks from baseline
Secondary	McGill Pain Questionnaire	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.	Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline
Secondary	Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)	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	Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline
Secondary	Motor Evoked Potentials	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	Baseline, End training:12-14 weeks from baseline
Secondary	Change From Baseline in Manual Muscle Test at End 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; palpable or visible contraction; active movement, gravity eliminated; active movement, against gravity; active movement, against some resistance; active movement, against full resistance	Baseline, end training:12 -14 weeks from baseline