Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury - Full Text View

Purpose

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. 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.

Condition	Intervention
Spinal Cord Injury	Device: ReWalk


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:

6 minute walk test [ Time Frame: up to 20 weeks ]
The maximum distance walked in 6 minutes
Heart rate change from sitting to the end of the 6 minute walk test [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of training ]
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.

Secondary Outcome Measures:

10 meter walk test [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of training ]
Fastest safe walking speed for 10 meters
Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) [ Time Frame: 12 weeks ]
Time it takes to do 7 specific walking tasks: 5 meters on carpet, 5 meters on smooth ground while carrying a bag with weights, timed-up-and-go, up and down one step, up and down 4 steps, walking while opening a door, walking over and around obstacles
Manual Muscle Test [ Time Frame: 12 weeks from beginning of training ]
Standard manual muscle test of lower and upper extremities
Spinal Cord Assessment Tool for Spastic reflexes (SCATS) [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of training ]
Response to 3 standardized tests: stretch of ankle plantarflexors, pin prick to the sole of the foot, stretch of the hip and knee flexors
Motor evoked potentials [ Time Frame: 6 weeks, 12 weeks from beginning of training ]
Single pulse transcranial magnetic stimulation over Cz. Responses in paraspinal muscles recorded at 8 levels
Electrical somatosensory perceptual threshold [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of training ]
Surface electrical stimulation at spinal levels specified by the American Spinal Cord Injury Association (ASIA) sensory points
Cutaneomuscular reflex threshold and response [ Time Frame: 6 weeks, 12 weeks from beginning of training ]
Surface electrical stimulation at the posterior tibial nerve (300 Hz, 5 pulses, 0.3 s duration), bilaterally, to determine the threshold for eliciting a response in the tibialis anterior muscle
Sitting and standing balance [ Time Frame: 6 weeks, 12 weeks, 20 weeks from beginning of training ]
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 participant will also sit/stand as still as possible with eyes closed
McGill Pain Questionnaire [ Time Frame: Weekly, up to 20 weeks from beginning of training ]
Paper/pencil questionnaire regarding pain experienced over the last week
Structured interview [ Time Frame: 12 weeks from beginning of training ]
An interview to obtain the participants expectations before the training, and his/her impressions after the training
Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: Biweekly, up to 20 weeks from beginning of training ]
Paper/pencil questionnaire with 9 questions


Estimated Enrollment:	15
Study Start Date:	June 2014
Estimated Study Completion Date:	June 2018
Estimated Primary Completion Date:	June 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ReWalk training ReWalk exoskeleton training: 1.5 hr/day, 5 days/week, for 12 weeks. 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 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.

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 SCI. 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 SCI.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

traumatic or non-traumatic spinal cord injury ≥1 year post-injury
Body height between 5'3" and 6'4"
Body weight ≤180 lbs
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02322125

Contacts


Contact: Donna Livingstone, BSc	7804922258	donna3@ualberta.ca
Contact: Caitlin Hurd, MSc	7804924858	clhurd@ualberta.ca

Locations


Canada, Alberta
University of Alberta	Recruiting
Edmonton, Alberta, Canada, T6G 2G4
Contact: Donna Livingstone, BSc 7804922258 carre@ualberta.ca
Contact: Jaynie Yang, Phd 7804922894 jaynie.yang@ualberta.ca
Principal Investigator: Jaynie Yang, PhD
Sub-Investigator: Richard B Stein, PhD
Sub-Investigator: Monica Gorassini, PhD
Sub-Investigator: John Misiaszek, PhD
Sub-Investigator: Francois Roy, PhD

Sponsors and Collaborators

University of Alberta

Investigators


Principal Investigator:	Jaynie F Yang, PhD	University of Alberta

More Information


Responsible Party:	University of Alberta
ClinicalTrials.gov Identifier:	NCT02322125 History of Changes
Other Study ID Numbers:	Pro00036789
Study First Received:	December 17, 2014
Last Updated:	June 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Pediatric Postmarket Surveillance of a Device Product:		No
Product Manufactured in and Exported from the U.S.:		Yes

Keywords provided by University of Alberta:


walking locomotion rehabilitation

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on July 17, 2017