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Clinical Trials/NCT03503617
NCT03503617
Completed
Not Applicable

RehabTouch: A Mixed-reality Gym for Rehabilitating the Hands, Arms, Trunk, and Legs After Stroke

Flint Rehabilitation Devices, LLC1 site in 1 country27 target enrollmentNovember 1, 2018
ConditionsCerebral Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Stroke
Sponsor
Flint Rehabilitation Devices, LLC
Enrollment
27
Locations
1
Primary Endpoint
Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
March 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Flint Rehabilitation Devices, LLC

Vice President

Flint Rehabilitation Devices, LLC

Eligibility Criteria

Inclusion Criteria

  • Age: 18 to 85 years old
  • Upper extremity weakness measured by a clinical scale
  • Absence of moderate to severe pain on affected upper extremity
  • Able to understand the instructions to operate RehabTouch

Exclusion Criteria

  • Concurrent severe medical problems, visual deficits, severe neglect or apraxia
  • Enrollment to other therapy studies

Outcomes

Primary Outcomes

Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy

Time Frame: From Baseline to One-month Post-therapy

The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly.

Secondary Outcomes

  • Change in Box and Blocks Test Score(From Baseline to One-month Post-therapy)
  • Motor Activity Log(One-month Post-therapy)
  • Visual Analog Pain Scale(From Baseline to One-month Post-therapy)
  • 10 Meter Walk Test(From Baseline to One-month Post-therapy)
  • Modified Ashworth Spasticity Scale(From Baseline to One-month Post-therapy)

Study Sites (1)

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