Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton (HandSOME)

Home Therapy for Upper Limb Stroke Rehabilitation Using the HandSOME Exoskeleton

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: HandSOME

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar National Rehabilitation Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HandSOME; The intervention is given to this group.	Device: HandSOME; Participants use the HandSOME orthosis daily for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fugl-Meyer Test of Arm Function	clinical test of arm motor ability and impairment	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	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	Change from baseline Motor Activity Log score at 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fugl-Meyer Test of Arm Function at followup	clinical test of arm motor ability and impairment	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	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	Change from baseline Motor Activity Log score at 5 months

Collaborators and Investigators

• Sponsor: The Catholic University of America
• Collaborators: MedStar National Rehabilitation Network

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Actual): October 7, 2019
• Study Completion (Actual): October 7, 2019

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2016-064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes