Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation

• ClinicalTrials.gov Identifier: NCT02104622
• Recruitment Status: Completed
• First Posted: April 4, 2014
• Last Update Posted: May 24, 2019
• Sponsor: Shirley Ryan AbilityLab
• Collaborator: U.S. Department of Education
• Information provided by (Responsible Party): Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injury	Device: ReWalk Rehabilitation 2.0	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation
• Study Start Date: February 2014
• Actual Primary Completion Date: December 2018
• Actual Study Completion Date: December 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: ReWalk training	Device: ReWalk Rehabilitation 2.0

Outcome Measures

Primary Outcome Measures :

1. 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) ]
   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
2. 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) ]
   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."
3. 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) ]
4. 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 Outcome Measures :

1. Patient perception of Quality of Life [ Time Frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks) ]
2. The Patient Health Questionnaire [ Time Frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks) ]
   PHQ-9 is a 9-item self-report questionnaire designed to diagnose both the presence of depressive symptoms as well as to characterize the severity of depression. A single question rates how difficult problems have made it to do work, take care of things at home or get along with other people using a 4 level scale (not difficult at all to extremely difficult).
3. The Psychosocial Impact of Assistive Devices Scale [ Time Frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks) ]
   The PIADS is a 26-item, self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life. The PIADS can be used to assess the impact of any assistive device (AD), prosthesis or medical procedure. It can be used to evaluate the impact of ADs over time and to match the devices with consumers. With its excellent psychometric properties, the PIADS fills a missing link in the assessment of ADs as well as in the examination of their acceptance and abandonment.
4. Activities-specific Balance Confidence Scale [ Time Frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks) ]
5. 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) ]
6. 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

• Ages Eligible for Study: 12 Years to 85 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Illinois

Rehabilitation Institute of Chicago

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Shirley Ryan AbilityLab

U.S. Department of Education

Investigators

• Principal Investigator: Arun Jayaraman, PT, PhD; Shirley Ryan AbilityLab

More Information

• Responsible Party: Arun Jayaraman, PT, PhD, Research Scientist, Shirley Ryan AbilityLab
• ClinicalTrials.gov Identifier: NCT02104622 History of Changes
• Other Study ID Numbers: 89259
• First Posted: April 4, 2014
• Last Update Posted: May 24, 2019
• Last Verified: May 2019

Keywords provided by Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab:

spinal cord injury; exoskeleton; ambulation; walking; robotics

Additional relevant MeSH terms:

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