Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation

NCT02104622 | Completed DMC

• 1 other identifier: 89259
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; exoskeleton; ambulation; walking; robotics

Outcome Measures

Primary Outcomes (4)

• Change in 6 Minute Walk Test from baseline in distance, RPE and oxygen uptake

  The goal is to cover as much ground as possible over 6 minutes, the distance is measured with a measuring wheel. The instructions are "Walk continuously if possible, but do not be concerned if you need to slow down or stop to rest." At the end of 6 minutes the participant is asked to rate their exertion level on a Borg Scale of 6 - 20 points. The VO2 MAX data is collected during the test every 10 seconds

  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

  Measure the time in second for and individual to walk 10 meters. The test is Performed using a "flying start," patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: " Please walk this distance as fast as you safely can when I say go."

  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.

  Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

• Distance able to reach while standing and sitting

  Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

Secondary Outcomes (6)

• Patient perception of Quality of Life

  Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

• The Patient Health Questionnaire

  Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

• The Psychosocial Impact of Assistive Devices Scale

  Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

• Activities-specific Balance Confidence Scale

  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

  Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

Study Arms (1)

ReWalk training

EXPERIMENTAL

Device: ReWalk Rehabilitation 2.0

Interventions

ReWalk Rehabilitation 2.0 DEVICE

ReWalk training

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

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

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: April 4, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

US (1)