Cerebral Stroke
Conditions
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.
Interventions
DEVICEFitMi 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.
DEVICEFitMi Basic
A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.
Sponsors
University of California, Irvine
Rancho Research Institute, Inc.
Flint Rehabilitation Devices, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor Activity Log | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper Extremity Fugl-Meyer | Baseline and One-Month Post-Treatment, at seven weeks | A standardized assessment of arm impairment based on scores of 0-2 on 33 different tasks. Minimum value = 0, maximum value = 66, higher scores = better outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 25 |
| 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.
FitMi Basic: A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | FitMi Basic | Total | FitMi Plus |
|---|---|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 13 | 55.2 years STANDARD_DEVIATION 13.9 | 56.4 years STANDARD_DEVIATION 14.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 25 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 21 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 20 Participants | 8 Participants |
| Race (NIH/OMB) White | 9 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 8 Participants |
| Sex: Female, Male Male | 19 Participants | 36 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
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. Minimum value = 0, maximum value = 5, higher scores = better outcome
Time frame: Baseline and One-Month Post-Treatment, at seven weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FitMi Plus | Change in Motor Activity Log | Amount of Use | 0.60 score on a scale | Standard Deviation 0.53 |
| FitMi Plus | Change in Motor Activity Log | Quality of Movement | 0.64 score on a scale | Standard Deviation 0.48 |
| FitMi Basic | Change in Motor Activity Log | Amount of Use | 0.40 score on a scale | Standard Deviation 0.39 |
| FitMi Basic | Change in Motor Activity Log | Quality of Movement | 0.44 score on a scale | Standard Deviation 0.35 |
p-value: 0.11t-test, 2 sided
Secondary
Change in Upper Extremity Fugl-Meyer
A standardized assessment of arm impairment based on scores of 0-2 on 33 different tasks. Minimum value = 0, maximum value = 66, higher scores = better outcome
Time frame: Baseline and One-Month Post-Treatment, at seven weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FitMi Plus | Change in Upper Extremity Fugl-Meyer | 2.0 score on a scale | Standard Deviation 3.3 |
| FitMi Basic | Change in Upper Extremity Fugl-Meyer | 1.0 score on a scale | Standard Deviation 2.8 |