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FitMi Plus Home Therapy for Stroke Patients

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ClinicalTrials.gov Identifier: NCT03935425
Recruitment Status : Not yet recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
University of California, Irvine
Information provided by (Responsible Party):
Daniel Zondervan, Flint Rehabilitation Devices, LLC

Brief Summary:
The investigators will investigate the efficacy of a newly developed functional exercise device (FitMi Plus) for people in the chronic stage after a stroke compared to the FitMi Basic (i.e. without functional exercises). FitMi Plus combines objects commonly used during activities of daily living with sensors that can track and record the patient's direction and degree of movement as they perform specific functional tasks described on a computer.

Condition or disease Intervention/treatment Phase
Cerebral Stroke Device: FitMi Plus Device: FitMi Basic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: FitMi Plus

Participants will perform targeted movement exercises by interacting with the FitMi Plus Functional modules at least 50% of the time they spend exercising.

Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.

Device: FitMi Plus
A set of common objects that couple with a wireless sensor platform to allow the performance of functional exercises to be measured by a motivating software platform.

Active Comparator: FitMi Basic

Participants will perform targeted movement exercises by interacting with the FitMi Basic pucks, as described and monitored on a computer.

Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.

Device: FitMi Basic
A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.




Primary Outcome Measures :
  1. Change in Motor Activity Log [ Time Frame: Baseline, Immediately Post-Treatment, One-Month Post-Treatment. ]
    A self-reported measure of the quality of movement and amount of use of the impaired upper extremity across a set of activities of daily living.


Secondary Outcome Measures :
  1. Change in Upper Extremity Fugl-Meyer [ Time Frame: Baseline, Immediately Post-Treatment, One-Month Post-Treatment. ]
    A standardized assessment of arm impairment based on scores of 0-2 on 33 different tasks.

  2. Action Research Arm Test [ Time Frame: Baseline, Immediately Post-Treatment, One-Month Post-Treatment. ]

    A 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).

    Performance on each item is rated on a 4-point ordinal scale ranging from:

    3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty

    1) Performs test partially 0) Can perform no part of test


  3. Modified Ashworth Spasticity Scale [ Time Frame: Baseline, Immediately Post-Treatment, One-Month Post-Treatment ]
    Tests resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 6 choices.

  4. Visual Analog Pain Scale [ Time Frame: Baseline, Immediately Post-Treatment, One-Month Post-Treatment. ]
    The Visual Analog Pain Scale is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The scale ranges from 0) "no pain" to 10) "worst possible, unbearable pain"

  5. Wearable Activity Tracking [ Time Frame: Baseline, One-Month Post-Treatment. ]
    Participants wear a custom-designed wrist-mounted actigrapher (the Manumeter, which uses wrist-worn magnetometers and a magnet worn on the finger to monitor functional use of the upper extremity activity) for a 24 hour period to assess changes in functional activity levels.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Experienced 1 or more strokes >6 months prior to enrollment
  • Upper Extremity Fugl-Meyer Score >=15 and <=55 out of 66
  • Absence of moderate to severe upper extremity pain (<= 4 out of 10 on the visual-analog pain scale)
  • Ability to understand the instructions to operate FitMi products

Exclusion Criteria:

  • Lack of concurrent severe medical problems
  • Lack of visual deficits
  • Lack of severe neglect or apraxia
  • No concurrent enrollment in another therapy study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935425


Contacts
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Contact: Daniel Zondervan, PhD 949-313-7322 dzondervan@flintrehab.com

Locations
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United States, California
Human Neuroperformance Laboratory at University of California Irvine Not yet recruiting
Irvine, California, United States, 926170000
Contact: David Reinkensmeyer, PhD    949-824-5218    dreinken@uci.edu   
Sponsors and Collaborators
Flint Rehabilitation Devices, LLC
University of California, Irvine
Investigators
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Principal Investigator: David Reinkensmeyer, PhD University of California, Irvine

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Responsible Party: Daniel Zondervan, Vice President, Flint Rehabilitation Devices, LLC
ClinicalTrials.gov Identifier: NCT03935425     History of Changes
Other Study ID Numbers: 1R44HD097803-01 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases