Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton

Phase 1

Completed

• Conditions: Stroke
• Interventions: Device: HandSOME

• Registration Number: NCT03263286
• Lead Sponsor: The Catholic University of America

Brief 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.

Study Timeline

• Study Start: 2017-04-15
• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-28
• Primary Completion: 2019-10-07
• Study Completion: 2019-10-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

1. 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
2. Have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols
3. Have serious uncontrolled medical problems as judged by the project therapist
4. Receiving oral or injected antispasticity medications during study treatment
5. MCP and IP passive extension limit > 30 degrees from full extension
6. Excessive tone in the fingers and thumb as determined by Ashworth scores >=3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HandSOME	HandSOME	The intervention is given to this group.

Primary Outcome Measures

Name	Time	Method
Change in Action Research Arm Test	Change from baseline Action Research Arm Test score at 2 months	clinical test of the functional limitations of the upper extremities
Change in Fugl-Meyer Test of Arm Function	Change from baseline Fugl-Meyer score at 2 months	clinical test of arm motor ability and impairment
Change in Motor Activity Log	Change from baseline Motor Activity Log score at 2 months	assess the amount and quality of limb use at home

Secondary Outcome Measures

Name	Time	Method
Change in Motor Activity Log at followup	Change from baseline Motor Activity Log score at 5 months	assess the amount and quality of limb use at home
Change in Action Research Arm Test at followup	Change from baseline Action Research Arm Test score at 5 months	clinical test of the functional limitations of the upper extremities
Change in Fugl-Meyer Test of Arm Function at followup	Change from baseline Fugl-Meyer score at 5 months	clinical test of arm motor ability and impairment

Trial Locations

Locations (1)

MedStar National Rehabilitation Network; 🇺🇸 Washington, District of Columbia, United States