Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury

NCT02322125 | Completed Results FDA Device

• 1 other identifier: Pro00036789
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

walking; locomotion; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 10 Meter Walk Test

  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)

• Max Distance

  End of training:12-14 weeks from baseline

• Limits of Stability - Sitting

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

• Sitting Sway

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

• McGill Pain Questionnaire

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

Study Arms (1)

ReWalk training

EXPERIMENTAL

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.

Device: ReWalk

Interventions

ReWalk 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.

ReWalk training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

Location

Related Publications (2)

• 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.

  PMID: 31752911 BACKGROUND

• 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.

  PMID: 31324256 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

Small number of participants suggests data should be interpreted with caution.

Results Point of Contact

• Title: Dr. Jaynie Yang
• Organization: University of Alberta

jaynie.yang@ualberta.ca

780-492-2894

Study Officials

• Jaynie F Yang, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: June 1, 2014
• Primary Completion: August 20, 2018
• Study Completion: September 26, 2018
• Last Updated: October 14, 2021
• Results First Posted: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)