Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury

University of Alberta

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Device: ReWalk

Study type: Interventional

Funder types: Other

Identifiers

NCT02322125

Pro00036789

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

ReWalk training

Experimental group

Description:

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.

Treatment:

Device: ReWalk