Overview

This trial is active, not recruiting.

Condition spinal cord injury
Treatment rewalk rehabilitation 2.0
Phase phase 2
Sponsor Rehabilitation Institute of Chicago
Collaborator U.S. Department of Education
Start date February 2014
End date September 2017
Trial size 20 participants
Trial identifier NCT02104622, 89259

Summary

Many people with spinal cord injury are no longer able to walk and must use wheelchairs for mobility. These individuals experience greater rates of depression and lower quality of life. Many of these individuals express a strong desire to walk again, and report many psychosocial benefits to being eye to eye with peers in social interactions. Additionally, wheelchairs allow only limited community access, creating an additional obstacle to seeking out meaningful social roles in the community. Currently, there is new technology called robotic exoskeletons that would allow people with spinal cord injury to walk. These robotic exoskeletons also allow for curb, ramp, and stair negotiation, which are critical to community access. Current research has examined training with robotic exoskeletons indoors over level surfaces in clinical settings. This study will examine the potential for everyday use, including ramps, stairs, curbs and indoor and outdoor use.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
rewalk rehabilitation 2.0

Primary Outcomes

Measure
Change in 6 Minute Walk Test from baseline in distance, RPE and oxygen uptake
time frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Change in 10 meter walk test from baseline in gait speed
time frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Time and assistive level to negotiate stairs, ramps, curbs, and turning.
time frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Distance able to reach while standing and sitting
time frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

Secondary Outcomes

Measure
Patient perception of Quality of Life
time frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
The Patient Health Questionnaire
time frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
The Psychosocial Impact of Assistive Devices Scale
time frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Activities-specific Balance Confidence Scale
time frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Self reported Spinal Cord Independence Measure in activities of daily living
time frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Pain measure by the Visual Analogue Scale
time frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

Eligibility Criteria

Male or female participants from 12 years up to 85 years old.

Inclusion Criteria: - SCI level C6-8, T1-T12; L1-L5 incomplete or complete - Be able to physically fit into the exoskeleton device; - Be able to tolerate upright standing for a minimum of 30 minutes; - Have sufficient upper body strength to use forearm crutches in standing and during ambulation (including full triceps strength and good hand function); - Have hip, knee, and ankle range of motion within normal functional limits of walking; - Have the ability to follow directions and demonstrate learning capacity; - Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: - Cervical level SCI above C6 - History of severe osteoporosis; - Weight above 220 pounds; - Femur length above 47 cm or below 36 cm - Joint contractures at the hip, knee, or ankle that limit normal range of motion (ROM) during ambulation; - Cognitive and/or communication disability (e.g. due to brain injury); - History of significant problems with skin break down or current skin break down; - Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity); - Pregnancy; - Cardiovascular conditions such as history of heart attack, high blood pressure, pacemaker, arrhythmia, heart failure, or stroke.

Additional Information

Official title Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation
Principal investigator Arun Jayaraman, PT, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Rehabilitation Institute of Chicago.