Hand Exoskeleton Training Study

NCT ID: NCT06786858

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-04

Study Completion Date

2025-01-31

Brief Summary

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The goal of this study is to evaluate the HandMATE device's effectiveness in the rehabilitation of stroke patients and asses if the HandMATE application is received well by stroke survivors.

Participants will use the HandMate device in clinic and in the home. They will also complete clinical upper extremity assessments.

Detailed Description

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This study will evaluate the effectiveness of novel device and its potential to help stroke victims regain functional use of their hand and regain independent living. The study will also evaluate the potential of the device to be used at home, this would allow increased therapy intensity and decreased overall treatment costs (fewer therapist hours required and decreased travel costs).

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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HandMate Use

HandMate device fitted for a stroke participant.

Group Type EXPERIMENTAL

HandMate

Intervention Type DEVICE

HandMate device is used for 20 hours in 4 weeks. Device is then used in the home for 3 months at discretion of participant.

Interventions

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HandMate

HandMate device is used for 20 hours in 4 weeks. Device is then used in the home for 3 months at discretion of participant.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age of 21 or older
* diagnosis of stroke more than 6 months prior confirmed from MRI or CT
* voluntary hand activity (score of 1 or more, finger extension item, Fugl-Meyer Test)
* adequate cognitive status
* Impaired ability to open affected hand

Exclusion Criteria

* hemispatial neglect
* severe sensory loss (2 or more on the sensory item, NIH Stroke Scale/Score)
* receiving or planning to receive antispasticity medications during enrollment into the study
* less than full passive range of motion in finger joints
* receiving physical or occupational therapy outside of study protocols
* have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pete Lum, PhD

Role: PRINCIPAL_INVESTIGATOR

MedStar RI

Locations

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MedStar National Rehabilitation Hospital

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan L Grainger

Role: CONTACT

2028771464

Facility Contacts

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Megan L Grainger

Role: primary

202-877-1464

Other Identifiers

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00004431

Identifier Type: -

Identifier Source: org_study_id

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