Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton

NCT ID: NCT03263286

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-15
• Study Completion Date: 2019-10-07

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HandSOME

The intervention is given to this group.

Group Type: EXPERIMENTAL

HandSOME

Intervention Type: DEVICE

Participants use the HandSOME orthosis daily for 8 weeks.

Interventions

HandSOME

Participants use the HandSOME orthosis daily for 8 weeks.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedStar National Rehabilitation Network

OTHER

Sponsor Role: collaborator

The Catholic University of America

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MedStar National Rehabilitation Network

Washington D.C., District of Columbia, United States

Countries

United States

References

Tianyao Chen, Lum PS. Hand rehabilitation after stroke using a wearable, high DOF, spring powered exoskeleton. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:578-581. doi: 10.1109/EMBC.2016.7590768.

Reference Type: BACKGROUND

PMID: 28324934 (View on PubMed)

Other Identifiers

2016-064

Identifier Type: -

Identifier Source: org_study_id