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Hand Exoskeleton Training Study (HandMATE)

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MedStar Health

Status

Enrolling

Conditions

Stroke

Treatments

Device: HandMate

Study type

Interventional

Funder types

Other

Identifiers

NCT06786858
00004431

Details and patient eligibility

About

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.

Full description

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).

Enrollment

15 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

HandMate Use
Experimental group
Description:
HandMate device fitted for a stroke participant.
Treatment:
Device: HandMate

Trial contacts and locations

1

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Central trial contact

Megan L Grainger

Data sourced from clinicaltrials.gov

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