Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ReWalk Rehabilitation 2.0

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring spinal cord injury, exoskeleton, ambulation, walking, robotics

Eligibility Criteria

12 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rehabilitation Institute of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ReWalk training

Arm Description

Outcomes

Primary Outcome Measures

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

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."

Time and assistive level to negotiate stairs, ramps, curbs, and turning.

Distance able to reach while standing and sitting

Secondary Outcome Measures

Patient perception of Quality of Life

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).

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.

Activities-specific Balance Confidence Scale

Self reported Spinal Cord Independence Measure in activities of daily living

Pain measure by the Visual Analogue Scale

Full Information

NCT ID

NCT02104622

First Posted

February 26, 2014

Last Updated

May 20, 2020

Sponsor

Shirley Ryan AbilityLab

Collaborators

U.S. Department of Education

1. Study Identification

Unique Protocol Identification Number

NCT02104622

Brief Title

Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation

Official Title

Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

January 2020 (Actual)

Study Completion Date

January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shirley Ryan AbilityLab

Collaborators

U.S. Department of Education

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury

Keywords

spinal cord injury, exoskeleton, ambulation, walking, robotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ReWalk training

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

ReWalk Rehabilitation 2.0

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame