Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton

Completed · Phase 1

Conditions studied: Stroke

In brief

This research will evaluate the potential for a novel hand orthosis (HandSOME) to help stroke victims regain functional use of their hand and regain independent living. Participants will use the HandSOME at home regularly for 8 weeks. Clinical evaluations will measure changes from the intervention after the 8 weeks and also at a 3 month followup.

Key facts

Study ID

NCT03263286

Run by

The Catholic University of America

People needed

15

Starts

2017-04-15

Expected to finish

2019-10-07

Last updated by the study team

2020-08-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of stroke more than six months prior to entry into the study
• Impaired ability to open affected the hand
• At least trace ability to extend the wrist and fingers

You may not qualify if…

• Have cognitive deficits that could negatively affect their ability to complete the protocols as evidenced by a score of 24 or less on the Folstein Mini-Mental State Examination
• Have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols
• Have serious uncontrolled medical problems as judged by the project therapist
• Receiving oral or injected antispasticity medications during study treatment
• MCP and IP passive extension limit > 30 degrees from full extension
• Excessive tone in the fingers and thumb as determined by Ashworth scores >=3

Where it is running

• MedStar National Rehabilitation Network — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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