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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

FitMi Plus Home Therapy for Stroke Patients

Clinicaltrials.gov identifier NCT03935425

Recruitment Status Not yet recruiting

First Posted May 2, 2019

Last update posted September 16, 2020

Study Description

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:Cerebral Stroke
  • Intervention/Treatment: Device: FitMi Plus
    Device: FitMi Basic
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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: December 2020
  • Estimated Primary Completion Date: October 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
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.
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 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

Contacts and Locations
Contacts

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

Locations

United States, California
Human Neuroperformance Laboratory at University of California Irvine
Irvine

Sponsors and Collaborators

Flint Rehabilitation Devices, LLC

University of California, Irvine

Investigators

Principal Investigator: David Reinkensmeyer, PhD University of California, Irvine

More Information
  • Responsible Party: Flint Rehabilitation Devices, LLC
  • ClinicalTrials.gov Identifier: NCT03935425 History of Changes
  • Other Study ID Numbers: 1R44HD097803-01
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: September 16, 2020
  • Last Verified: September 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Stroke