Recruiting

Hand Exoskeleton

Sponsor:

Medstar Health Research Institute

Code:

NCT06786858

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

HandMate

Study Details

Brief summary:

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.

Conditions

Stroke

Study ID

NCT06786858

Start date

Jan 4, 2022

Status verified date

Jan, 2025

Completion date

Jan 31, 2025

Anticipated

Primary completion date

Jan 4, 2024

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: HandMate Use

HandMate device fitted for a stroke participant.

Interventions

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.

Primary outcome measure

  • Fugl-Meyer Upper Extremity (FMA-UE) Test [ Time Frame: Change from baseline Fugl-Meyer score at 6 weeks ]
  • Action Research Arm Test (ARAT) [ Time Frame: Change from baseline ARAT score at 6 weeks ]
  • Motor Activity Log [ Time Frame: Change from baseline MAL score at 6 weeks ]

Central Contacts and Locations

Central contacts

Megan L Grainger

2028771464megan.l.grainger@medstar.net

Locations

MedStar National Rehabilitation Hospital

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Megan L Grainger

202-877-1464megan.l.grainger@medstar.net

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Jan 22, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2025-01-22.