FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Change in Motor Activity Log
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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: FitMi Plus (Device)
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: FitMi Basic (Device)
Outcomes
Primary Outcomes
Change in Motor Activity Log
Time Frame: Baseline and One-Month Post-Treatment, at seven weeks
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. Minimum value = 0, maximum value = 5, higher scores = better outcome
Secondary Outcomes
- Change in Upper Extremity Fugl-Meyer(Baseline and One-Month Post-Treatment, at seven weeks)
Investigators
Flint Rehabilitation Devices, LLC
Vice President
Flint Rehabilitation Devices, LLC