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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReWalk™ device | Experimental | Self-controlled group; single cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReWalk™ device | Device | Twenty one-hour ReWalk™ training sessions are scheduled for each participant over a 10-week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 10-meter walking test (10MWT) | Change in score between 0 and 10 weeks. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minutes walk test (6MWT) | Change in score between 0 and 10 weeks. | 10 weeks |
| Timed Up and Go (TUG) test | Change in score between 0 and 10 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Stair management | Exact timing pending learning curve, change in score in weeks up to 10 weeks. | 10 weeks |
| Obstacle course | Exact timing pending learning curve, change in score in weeks up to 10 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joost J. van Middendorp, MD, PhD | Contact | +44 1296 316783 | Joost.vanMiddendorp@buckshealthcare.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Joost J. van Middendorp, MD, PhD | Stoke Mandeville Spinal Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Spinal Injuries Centre, Stoke Mandeville Hospital | Recruiting | Aylesbury | Buckinghamshire | HP21 8AL | United Kingdom |
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| Label | URL |
|---|---|
| Website directing to project description and updates | View source |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D000067190 | Exoskeleton Device |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| 10 weeks |
| Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire | Change in score between 0 and 10 weeks. | 10 weeks |
| Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire | Change in score between 0 and 10 weeks. | 10 weeks |
| 10 weeks |
| D014947 | Wounds and Injuries |