Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton

NCT03263286 | Completed Phase 1 FDA Device

• 1 other identifier: 2016-064
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in Fugl-Meyer Test of Arm Function at followup

  Change from baseline Fugl-Meyer score at 5 months

• Change in Action Research Arm Test at followup

  Change from baseline Action Research Arm Test score at 5 months

• Change in Motor Activity Log at followup

  Change from baseline Motor Activity Log score at 5 months

Study Arms (1)

HandSOME

EXPERIMENTAL

The intervention is given to this group.

Device: HandSOME

Interventions

HandSOME DEVICE

Participants use the HandSOME orthosis daily for 8 weeks.

HandSOME

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Catholic University of America: lead
• MedStar National Rehabilitation Network: collaborator

Study Sites (1)

MedStar National Rehabilitation Network

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• 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.

  PMID: 28324934 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 28, 2017
• Study Start: April 15, 2017
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)