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ReWalk 6.0Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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Correlated MeSH Terms (1)

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D013119 Spinal Cord Injuries NIH 0.50

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Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 CSP #2003 - Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life

Background Veterans with spinal cord injury (SCI) have many adverse secondary medical and quality of life (QOL) changes as a result of immobilization. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care (SOC) for mobility. Powered exoskeletons are a technology that has recently become available as an alternate form of mobility by providing an external framework for support and computer controlled motorized hip and knee joints to assist with over ground ambulation.

NCT02658656 Spinal Cord Injury Device: ReWalk 6.0
MeSH:Spinal Cord Injuries

Primary Outcomes

Description: The Veterans RAND 36 Item Health Survey (VR-36) is a brief, generic, multi-use, self-administered health survey comprised of 36 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health. The outcome in this study is the score from the Mental Health Component Summary (MCS) of the VR-36, which measures the vitality, social functioning, role-emotional, and mental health of the participant.

Measure: Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36)

Time: Change from Baseline Assessment to 4 Months Post Intervention

Description: The Spinal Cord Injury - Quality of Life (SCI-QOL) measurement tool was developed to assess patient reported outcome measures in persons with SCI. It is comprised of four broad domains of physical-medical health, emotional health, social participation, and physical functioning. Primary Outcome #2 will be a sum of the scores on the Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference item banks within the Physical-Medical Health domain.

Measure: The sum T-score for the SCI-QOL Physical Medical Health domain (three item banks of Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference)

Time: Change from Baseline Assessment to 4 Months Post Intervention

Secondary Outcomes

Description: Total body fat mass as measured by DXA (Dual energy X-Absorptiometry) scan.

Measure: Total Body Fat Mass (Kg)

Time: Change from Baseline Assessment to 4 Months Post Intervention

No related HPO nodes (Using clinical trials)