- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02104622
Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation
May 20, 2020 updated by: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Rehabilitation Institute of Chicago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 85 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ReWalk training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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
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Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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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)
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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."
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Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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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)
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Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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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)
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Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient perception of Quality of Life
Time Frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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The Patient Health Questionnaire
Time Frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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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).
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Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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The Psychosocial Impact of Assistive Devices Scale
Time Frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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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.
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Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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Activities-specific Balance Confidence Scale
Time Frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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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)
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Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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Pain measure by the Visual Analogue Scale
Time Frame: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
February 26, 2014
First Submitted That Met QC Criteria
April 1, 2014
First Posted (Estimate)
April 4, 2014
Study Record Updates
Last Update Posted (Actual)
May 21, 2020
Last Update Submitted That Met QC Criteria
May 20, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 89259
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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