Clinical trial NCT02322125: Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury
Official title: Restoring Walking With a Powered Exoskeleton After Complete and Sever Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: walking
locomotion
rehabilitation
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physiological Cost Index (PCI) Ratio
timeFrame: End of training:12-14 weeks from baseline
Secondary outcomes:
measure: 10 Meter Walk Test
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)
measure: Max Distance
timeFrame: End of training:12-14 weeks from baseline
measure: Limits of Stability - Sitting
timeFrame: Baseline, Mid point-6 weeks from baseline, End training:12-14 weeks from baseline
measure: Sitting Sway
timeFrame: Baseline, Mid-point:6 weeks from baseline, End training:12-14 weeks from baseline
measure: McGill Pain Questionnaire
timeFrame: Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline
measure: Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)
timeFrame: Baseline, midpoint:6 weeks from baseline, end training:12-14 weeks from baseline
measure: Motor Evoked Potentials
timeFrame: Baseline, End training:12-14 weeks from baseline
measure: Change From Baseline in Manual Muscle Test at End of Training
timeFrame: Baseline, end training:12 -14 weeks from baseline
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jaynie F Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Manns PJ, Hurd C, Yang JF. Perspectives of people with spinal cord injury learning to walk using a powered exoskeleton. J Neuroeng Rehabil. 2019 Jul 19;16(1):94. doi: 10.1186/s12984-019-0565-1.