Back to resultsFitMi Plus Home Therapy for Stroke Patients
Primary Purpose
Cerebral Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FitMi Plus
FitMi Basic
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Stroke
Eligibility 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
Sites / Locations
- Rancho Research Institute, Inc
- Human Neuroperformance Laboratory at University of California Irvine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FitMi Plus
FitMi Basic
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Motor Activity Log
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
Change in Upper Extremity Fugl-Meyer
A standardized assessment of arm impairment based on scores of 0-2 on 33 different tasks.
Action Research Arm Test
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
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
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
Participants wear a custom-designed wrist-mounted actigrapher (the MiGo, which uses wrist-worn accelerometers to monitor functional use of the upper extremity activity) for a 24 hour period to assess changes in functional activity levels.
Full Information
NCT ID
NCT03935425
First Posted
April 25, 2019
Last Updated
February 22, 2023
Sponsor
Flint Rehabilitation Devices, LLC
Collaborators
University of California, Irvine, Rancho Research Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03935425
Brief Title
FitMi Plus Home Therapy for Stroke Patients
Official Title
FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Flint Rehabilitation Devices, LLC
Collaborators
University of California, Irvine, Rancho Research Institute, Inc.
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FitMi Plus
Arm Type
Experimental
Arm Description
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.
Arm Title
FitMi Basic
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
FitMi Plus
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
FitMi Basic
Intervention Description
A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.
Primary Outcome Measure Information:
Title
Change in Motor Activity Log
Description
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.
Time Frame
Baseline, Immediately Post-Treatment, One-Month Post-Treatment.
Secondary Outcome Measure Information:
Title
Change in Upper Extremity Fugl-Meyer
Description
A standardized assessment of arm impairment based on scores of 0-2 on 33 different tasks.
Time Frame
Baseline, Immediately Post-Treatment, One-Month Post-Treatment.
Title
Action Research Arm Test
Description
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
Time Frame
Baseline, Immediately Post-Treatment, One-Month Post-Treatment.
Title
Modified Ashworth Spasticity Scale
Description
Tests resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 6 choices.
Time Frame
Baseline, Immediately Post-Treatment, One-Month Post-Treatment
Title
Visual Analog Pain Scale
Description
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"
Time Frame
Baseline, Immediately Post-Treatment, One-Month Post-Treatment.
Title
Wearable Activity Tracking
Description
Participants wear a custom-designed wrist-mounted actigrapher (the MiGo, which uses wrist-worn accelerometers to monitor functional use of the upper extremity activity) for a 24 hour period to assess changes in functional activity levels.
Time Frame
Baseline, One-Month Post-Treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Reinkensmeyer, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Shaw, MD
Organizational Affiliation
Rancho Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Research Institute, Inc
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Human Neuroperformance Laboratory at University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
926170000
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FitMi Plus Home Therapy for Stroke Patients
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