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出境医 / 临床实验 / FitMi Plus Home Therapy for Stroke Patients

FitMi Plus Home Therapy for Stroke Patients

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

Study Design
Layout table for study information
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 : April 1, 2021
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 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
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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
Contacts and Locations

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
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
Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date February 4, 2021
Estimated Study Start Date  ICMJE April 1, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • 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.
  • 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
  • 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.
  • 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"
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FitMi Plus Home Therapy for Stroke Patients
Official Title  ICMJE FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Stroke
Intervention  ICMJE
  • 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.
  • Device: FitMi Basic
    A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.
Study Arms  ICMJE
  • 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.

    Intervention: Device: FitMi Plus
  • 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.

    Intervention: Device: FitMi Basic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniel Zondervan, PhD 949-313-7322 dzondervan@flintrehab.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935425
Other Study ID Numbers  ICMJE 1R44HD097803-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Zondervan, Flint Rehabilitation Devices, LLC
Study Sponsor  ICMJE Flint Rehabilitation Devices, LLC
Collaborators  ICMJE University of California, Irvine
Investigators  ICMJE
Principal Investigator: David Reinkensmeyer, PhD University of California, Irvine
PRS Account Flint Rehabilitation Devices, LLC
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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