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Exoskeletons for Spinal Cord Injury: A Feasibility Study

Primary Purpose

Spinal Cord Injury

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
ReWalk™ device
Sponsored by
Buckinghamshire Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injury focused on measuring Spinal Cord Injury

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Spinal Injuries Centre, Stoke Mandeville HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ReWalk™ device

Arm Description

Self-controlled group; single cohort.

Outcomes

Primary Outcome Measures

10-meter walking test (10MWT)
Change in score between 0 and 10 weeks.

Secondary Outcome Measures

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

Full Information

First Posted
July 22, 2013
Last Updated
September 16, 2013
Sponsor
Buckinghamshire Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01943669
Brief Title
Exoskeletons for Spinal Cord Injury: A Feasibility Study
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buckinghamshire Healthcare NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ReWalk™ device
Arm Type
Experimental
Arm Description
Self-controlled group; single cohort.
Intervention Type
Device
Intervention Name(s)
ReWalk™ device
Other Intervention Name(s)
Exoskeleton, Bionic suit
Intervention Description
Twenty one-hour ReWalk™ training sessions are scheduled for each participant over a 10-week period.
Primary Outcome Measure Information:
Title
10-meter walking test (10MWT)
Description
Change in score between 0 and 10 weeks.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
6-minutes walk test (6MWT)
Description
Change in score between 0 and 10 weeks.
Time Frame
10 weeks
Title
Timed Up and Go (TUG) test
Description
Change in score between 0 and 10 weeks.
Time Frame
10 weeks
Title
Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire
Description
Change in score between 0 and 10 weeks.
Time Frame
10 weeks
Title
Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire
Description
Change in score between 0 and 10 weeks.
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Stair management
Description
Exact timing pending learning curve, change in score in weeks up to 10 weeks.
Time Frame
10 weeks
Title
Obstacle course
Description
Exact timing pending learning curve, change in score in weeks up to 10 weeks.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joost J. van Middendorp, MD, PhD
Phone
+44 1296 316783
Email
Joost.vanMiddendorp@buckshealthcare.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joost J. van Middendorp, MD, PhD
Organizational Affiliation
Stoke Mandeville Spinal Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Spinal Injuries Centre, Stoke Mandeville Hospital
City
Aylesbury
State/Province
Buckinghamshire
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost J. van Middendorp, MD, PhD
Phone
+44 1296316783
Email
Joost.vanMiddendorp@buckshealthcare.nhs.uk
First Name & Middle Initial & Last Name & Degree
Joost J. van Middendorp, MD, PhD
First Name & Middle Initial & Last Name & Degree
I Benson, BSc
First Name & Middle Initial & Last Name & Degree
K Hart, BSc, MSc
First Name & Middle Initial & Last Name & Degree
D Tussler, BSc, MSc

12. IPD Sharing Statement

Links:
URL
http://www.smsf.org.uk/research%20introduction.htm
Description
Website directing to project description and updates

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Exoskeletons for Spinal Cord Injury: A Feasibility Study

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