Spinal Cord InjuryNCT02104622

Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation

A study testing ReWalk Rehabilitation 2.0 in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 85 years
Conditions the study is for: Spinal Cord Injury
What is being tested?: ReWalk Rehabilitation 2.0
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Feb 2014to Jan 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 85 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Rehabilitation Institute of Chicago
Chicago, Illinois, 60611

Other trials in United States

About this study

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
Being tested: ReWalk Rehabilitation 2.0
Keywords: spinal cord injury, exoskeleton, ambulation, walking, robotics
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ReWalk Rehabilitation 2.0Device

Study groups in NCT02104622
Study group	Role	What they receive
ReWalk training	Experimental	Not described Receives: Device: ReWalk Rehabilitation 2.0

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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."
Measured: 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.
Measured: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Distance able to reach while standing and sitting
Measured: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

Secondary outcomes (6)

Patient perception of Quality of Life
Measured: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
The Patient Health Questionnaire
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).
Measured: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
The Psychosocial Impact of Assistive Devices Scale
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.
Measured: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Activities-specific Balance Confidence Scale
Measured: 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
Measured: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)
Pain measure by the Visual Analogue Scale
Measured: Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Jan 2020

First posted4 Apr 2014 (estimated)
Study startFeb 2014
Primary completionJan 2020
Study completionJan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02104622
Sponsor's protocol ID: 89259
Status last verified: May 2020
First submitted: 26 Feb 2014
Last updated: 21 May 2020
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Implant for Walking After Incomplete SCI
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Paralysis; Quadriplegic, Quadraplegia
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tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
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Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes

All Spinal Cord Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation
ClinicalTrials.gov ID: NCT02104622
Acronym / sponsor ID: 89259
Conditions: Spinal Cord Injury
Keywords: spinal cord injury, exoskeleton, ambulation, walking, robotics
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Shirley Ryan AbilityLabUniversity, hospital or other
Collaborators: U.S. Department of Education
Study start: Feb 2014
Primary completion: Jan 2020 (actual)
Study completion: Jan 2020 (actual)
First posted: 4 Apr 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ReWalk training	Experimental	Device: ReWalk Rehabilitation 2.0

Who may qualify

Ages: 12 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ReWalk Rehabilitation 2.0	Device	ReWalk training

Primary outcome

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
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."
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)

6 secondary outcomes

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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.

Related trials for Spinal Cord Injury

Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arun Jayaraman, PT, PhD principal investigator

Shirley Ryan AbilityLab

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ReWalk Rehabilitation 2.0 in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02104622.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.