Exoskeletons for Spinal Cord Injury: A Feasibility Study
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|ClinicalTrials.gov Identifier: NCT01943669|
Recruitment Status : Unknown
Verified September 2013 by Buckinghamshire Healthcare NHS Trust.
Recruitment status was: Recruiting
First Posted : September 17, 2013
Last Update Posted : September 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Device: ReWalk™ device||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||June 2013|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
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.
- 10-meter walking test (10MWT) [ Time Frame: 10 weeks ]Change in score between 0 and 10 weeks.
- 6-minutes walk test (6MWT) [ Time Frame: 10 weeks ]Change in score between 0 and 10 weeks.
- Timed Up and Go (TUG) test [ Time Frame: 10 weeks ]Change in score between 0 and 10 weeks.
- Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire [ Time Frame: 10 weeks ]Change in score between 0 and 10 weeks.
- Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire [ Time Frame: 10 weeks ]Change in score between 0 and 10 weeks.
- Stair management [ Time Frame: 10 weeks ]Exact timing pending learning curve, change in score in weeks up to 10 weeks.
- Obstacle course [ Time Frame: 10 weeks ]Exact timing pending learning curve, change in score in weeks up to 10 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943669
|Contact: Joost J. van Middendorp, MD, PhD||+44 1296 316783||Joost.vanMiddendorp@buckshealthcare.nhs.uk|
|National Spinal Injuries Centre, Stoke Mandeville Hospital||Recruiting|
|Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL|
|Contact: Joost J. van Middendorp, MD, PhD +44 1296316783 Joost.vanMiddendorp@buckshealthcare.nhs.uk|
|Principal Investigator: Joost J. van Middendorp, MD, PhD|
|Sub-Investigator: I Benson, BSc|
|Sub-Investigator: K Hart, BSc, MSc|
|Sub-Investigator: D Tussler, BSc, MSc|
|Principal Investigator:||Joost J. van Middendorp, MD, PhD||Stoke Mandeville Spinal Foundation|