MedStar National Rehabilitation Network
Washington D.C., District of Columbia, 20010, United States
NCT Number: NCT03263286
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.
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Notify Me21 year and older
All sexes
Interventional
Phase 1
Washington D.C., District of Columbia, 20010, United States
After stroke, individuals often have great difficulty with using the affected hand in functional tasks. The hand frequently suffers from finger flexor hypertonia as well as finger extensor weakness. This leads to increased difficulty in grasp and release of objects. HandSOME is a light weight wearable hand orthosis that increases range of motion and decreases effort during grasping tasks. The goal of this study is to evaluate the HandSOME device's effectiveness in the rehabilitation of stroke patients through an 8 week intervention. Eligible subjects will use the device daily at home for 8 weeks with one visit per week to the clinic to evaluate progress and troubleshoot problems with the device. The hypotheses are that the gains from the 8 weeks of training will be statistically significant and clinically important (defined as gains of greater than 10% of full scale) in the domains of impairment, function and amount of arm use.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants use the HandSOME orthosis daily for 8 weeks.
Time frame: Change from baseline Fugl-Meyer score at 2 months
clinical test of arm motor ability and impairment
Time frame: Change from baseline Action Research Arm Test score at 2 months
clinical test of the functional limitations of the upper extremities
Time frame: Change from baseline Motor Activity Log score at 2 months
assess the amount and quality of limb use at home
Time frame: Change from baseline Fugl-Meyer score at 5 months
clinical test of arm motor ability and impairment
Time frame: Change from baseline Action Research Arm Test score at 5 months
clinical test of the functional limitations of the upper extremities
Time frame: Change from baseline Motor Activity Log score at 5 months
assess the amount and quality of limb use at home
The Catholic University of America
Other
Home Therapy for Upper Limb Stroke Rehabilitation Using the HandSOME Exoskeleton
Acronym: HandSOME
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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