Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06786858

Hand Exoskeleton Training Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar National Rehabilitation Hospital

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

Location status: Recruiting

Location contact

Megan L Grainger

CONTACT

[email protected]

202-877-1464

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

HandMate

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.

Primary outcomes

  1. Fugl-Meyer Upper Extremity (FMA-UE) Test

    Time frame: Change from baseline Fugl-Meyer score at 6 weeks

    Evaluates and measures recovery in post-stroke hemiplegic patients. The FMA-UE Test will assess upper limb motor impairments for this study. It is a 33-item test that measures motor and reflex function in the upper body. Each item is scored on a scale of 0-2, with 0 indicating inability, 1 indicating beginning ability, and 2 indicating normal. The total score ranges from 0-66, highest score indicating no disability.

  2. Action Research Arm Test (ARAT)

    Time frame: Change from baseline ARAT score at 6 weeks

    The ARAT is 19-item clinical assessment used to measure the functional ability of the upper extremity, particularly in individuals recovering from a stroke, by evaluating their performance on tasks like grasping, gripping, pinching, and gross arm movements. It is scored on a four-level ordinal scale (0-3). Highest score indicating normal movement.

  3. Motor Activity Log

    Time frame: Change from baseline MAL score at 6 weeks

    The Motor Activity Log will be used to assess use of the limb at home. Respondents rate how they use their more-impaired arm for activities of daily living (ADLs) in the home (brushing teeth, buttoning a shirt, etc.).

Study contacts

Contact information is provided by the study sponsor or research team.

Megan L Grainger

CONTACT

[email protected]

2028771464

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

Home Training for Upper Limb Stroke Rehabilitation Using a Hand Exoskeleton

Acronym: HandMATE

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.