NCT03263286

Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton

Home Therapy for Upper Limb Stroke Rehabilitation Using the HandSOME Exoskeleton

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: The Catholic University of America · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	HandSOME	Participants use the HandSOME orthosis daily for 8 weeks.

Timeline

• Start date: 2017-04-15
• Primary completion: 2019-10-07
• Completion: 2019-10-07
• First posted: 2017-08-28
• Last updated: 2020-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study