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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Rehabilitation Institute of Chicago

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ReWalk training
Device: ReWalk Rehabilitation 2.0

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
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
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."
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)
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)
Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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)
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).
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)
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.
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)
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)
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)
Session 1 (pre test, initial visit) and Session 20 (post test, between 6-8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shirley Ryan AbilityLab

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
U.S. Department of Education

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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