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Completed

NCT Number: NCT03263286

Home Therapy for 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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MedStar National Rehabilitation Network

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

HandSOME

Device

Participants use the HandSOME orthosis daily for 8 weeks.

Primary outcomes

  1. Change in Fugl-Meyer Test of Arm Function

    Time frame: Change from baseline Fugl-Meyer score at 2 months

    clinical test of arm motor ability and impairment

  2. Change in Action Research Arm Test

    Time frame: Change from baseline Action Research Arm Test score at 2 months

    clinical test of the functional limitations of the upper extremities

  3. Change in Motor Activity Log

    Time frame: Change from baseline Motor Activity Log score at 2 months

    assess the amount and quality of limb use at home

Secondary outcomes

  1. Change in Fugl-Meyer Test of Arm Function at followup

    Time frame: Change from baseline Fugl-Meyer score at 5 months

    clinical test of arm motor ability and impairment

  2. Change in Action Research Arm Test at followup

    Time frame: Change from baseline Action Research Arm Test score at 5 months

    clinical test of the functional limitations of the upper extremities

  3. Change in Motor Activity Log at followup

    Time frame: Change from baseline Motor Activity Log score at 5 months

    assess the amount and quality of limb use at home

Sponsors and collaborators

Lead sponsor

The Catholic University of America

Other

Collaborators

  • MedStar National Rehabilitation Network

Registry information

Official study title

Home Therapy for Upper Limb Stroke Rehabilitation Using the HandSOME Exoskeleton

Acronym: HandSOME

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2017
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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