Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton

Stroke Clinical Trial

— HandSOME  

Official title:

Home Therapy for Upper Limb Stroke Rehabilitation Using the HandSOME Exoskeleton

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263286
• Other study ID #: 2016-064
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2017
• Est. completion date: October 7, 2019

Study information

• Verified date: August 2020
• Source: The Catholic University of America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 7, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• HandSOME
Participants use the HandSOME orthosis daily for 8 weeks.

Locations

Country	Name	City	State
United States	MedStar National Rehabilitation Network	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of America	MedStar National Rehabilitation Network

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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