Exoskeletons for Spinal Cord Injury: A Feasibility Study

September 16, 2013 updated by: Buckinghamshire Healthcare NHS Trust

An Open, Longitudinal, Prospective, Non-randomized, Self-Controlled Feasibility Study to Investigate the Effect of the ReWalk™ Device on Mobility Outcomes in Patients With Chronic Spinal Cord Injury.

In this study, 10 volunteer participants with chronic spinal cord injury will undergo a 10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a lightweight brace-support suit containing motors at the hip and knee joints, rechargeable batteries and a computerized control system carried in a backpack. ReWalk™ users control their ambulation through subtle changes in centre of gravity and upper-body movements. Before, during and after training sessions the volunteers will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Functional outcomes primarily focus on ambulation outcomes and psychological outcomes primarily focus on predisposition and perceptions of disability. The outcomes of this pilot study will assist the investigators in the preparations of randomised controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, 10 volunteer participants with chronic spinal cord injury will undergo a 10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a lightweight brace-support suit containing motors at the hip and knee joints, rechargeable batteries and a computerized control system carried in a backpack. ReWalk™ users control their ambulation through subtle changes in centre of gravity and upper-body movements. Before, during and after training sessions the volunteers will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Twenty one-hour training sessions are scheduled for each participant over a 10-week period. Functional outcomes primarily focus on ambulation outcomes and psychological outcomes primarily focus on predisposition and perceptions of disability. The outcomes of this pilot study will assist the investigators in the preparations of randomised controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Buckinghamshire
      • Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL
        • Recruiting
        • National Spinal Injuries Centre, Stoke Mandeville Hospital
        • Sub-Investigator:
          • I Benson, BSc
        • Sub-Investigator:
          • K Hart, BSc, MSc
        • Sub-Investigator:
          • D Tussler, BSc, MSc

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

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B & C (Lower Extremity Motor Score <20)
  • Motor level of injury from Cervical level 7 to Lumbar level 1, according to ASIA guidelines
  • Male and non-pregnant, non-lactating female
  • Age 18-55 years old
  • At least 12 months after injury
  • Able to stand or maintain upright position with or without using a standing device (e.g., 'Easy stand')
  • Able to sit with hips and knees ≥90° flexion
  • Height of 160 to 190 cm
  • Weight of <100 kg

Exclusion Criteria:

  • History of severe neurological injuries other than spinal cord injury (eg. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
  • Concurrent medical diseases (eg. infections, circulatory, heart or lung, pressure sores) interfering with the study
  • Unstable spine or unhealed limbs or pelvic fractures
  • Limited range of motion (<90°) hip and knee joints, including severe contractures
  • Severe spasticity (Ashworth grade 4; ie. Affected part(s) rigid in flexion or extension) or uncontrolled clonus
  • Diagnosis of severe osteoporosis/penia as proven with pQCT or DXA.
  • Psychiatric or cognitive conditions that may interfere with the trial
  • Previous use of any exoskeletal robotic device
  • Patients incapable of providing informed consent

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: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ReWalk™ device
Self-controlled group; single cohort.
Device: ReWalk™ device
Twenty one-hour ReWalk™ training sessions are scheduled for each participant over a 10-week period.
Other Names:
  • Exoskeleton
  • Bionic suit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-meter walking test (10MWT)
Time Frame: 10 weeks
Change in score between 0 and 10 weeks.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minutes walk test (6MWT)
Time Frame: 10 weeks
Change in score between 0 and 10 weeks.
10 weeks
Timed Up and Go (TUG) test
Time Frame: 10 weeks
Change in score between 0 and 10 weeks.
10 weeks
Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire
Time Frame: 10 weeks
Change in score between 0 and 10 weeks.
10 weeks
Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire
Time Frame: 10 weeks
Change in score between 0 and 10 weeks.
10 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stair management
Time Frame: 10 weeks
Exact timing pending learning curve, change in score in weeks up to 10 weeks.
10 weeks
Obstacle course
Time Frame: 10 weeks
Exact timing pending learning curve, change in score in weeks up to 10 weeks.
10 weeks

Collaborators and Investigators

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

Sponsor

Buckinghamshire Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

June 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

July 22, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (ESTIMATE)

September 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/EE/0048 (UK NRES)

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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