Exoskeletons for Spinal Cord Injury: A Feasibility Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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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.

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: ReWalk™ device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReWalk™ device<br>Self-controlled group; single cohort. | Device: ReWalk™ device<br>* Twenty one-hour ReWalk™ training sessions are scheduled for each participant over a 10-week period.<br>* Other names: Bionic suit;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury