Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton

Catholic University of America (CUA)

Status and phase: Completed; Phase 1

Conditions: Stroke

Treatments: Device: HandSOME

Study type: Interventional

Funder types: Other

Identifiers

NCT03263286

2016-064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

HandSOME

Experimental group

Description:

The intervention is given to this group.

Treatment:

Device: HandSOME