Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury

NCT ID: NCT02322125

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-09-26

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ReWalk

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaynie F Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 31752911 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31324256 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00036789

Identifier Type: -

Identifier Source: org_study_id