A Phase 1 interventional study of HandSOME in Stroke, sponsored by The Catholic University of America. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-08-28.
Sponsored by The Catholic University of America · Phase 1, Interventional, and Treatment
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.
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.
Exclusion Criteria:
The intervention is given to this group.
Device: HandSOME
Participants use the HandSOME orthosis daily for 8 weeks.
Change in Fugl-Meyer Test of Arm Function
clinical test of arm motor ability and impairment
Time frame: Change from baseline Fugl-Meyer score at 2 months
Change in Action Research Arm Test
clinical test of the functional limitations of the upper extremities
Time frame: Change from baseline Action Research Arm Test score at 2 months
Change in Motor Activity Log
assess the amount and quality of limb use at home
Time frame: Change from baseline Motor Activity Log score at 2 months
Change in Fugl-Meyer Test of Arm Function at followup
clinical test of arm motor ability and impairment
Time frame: Change from baseline Fugl-Meyer score at 5 months
Change in Action Research Arm Test at followup
clinical test of the functional limitations of the upper extremities
Time frame: Change from baseline Action Research Arm Test score at 5 months
Change in Motor Activity Log at followup
assess the amount and quality of limb use at home
Time frame: Change from baseline Motor Activity Log score at 5 months
Plan to share: No
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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The Catholic University of America