Hand Exoskeleton Training Study

NCT06786858 | Recruiting FDA Device

• 1 other identifier: 00004431
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer Upper Extremity (FMA-UE) Test

  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.

  Change from baseline Fugl-Meyer score at 6 weeks

• Action Research Arm Test (ARAT)

  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.

  Change from baseline ARAT score at 6 weeks

• Motor Activity Log

  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.).

  Change from baseline MAL score at 6 weeks

Study Arms (1)

HandMate Use

EXPERIMENTAL

HandMate device fitted for a stroke participant.

Device: HandMate

Interventions

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.

HandMate Use

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar National Rehabilitation Hospital

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

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Pete Lum, PhD

  MedStar RI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan L Grainger

CONTACT

2028771464; megan.l.grainger@medstar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: January 22, 2025
• Study Start: January 4, 2022
• Primary Completion: January 4, 2024
• Study Completion: January 31, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

US (1)