Trial Outcomes & Findings for FitMi Plus Home Therapy for Stroke Patients (NCT NCT03935425)
NCT ID: NCT03935425
Last Updated: 2024-03-12
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline and One-Month Post-Treatment, at seven weeks
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FitMi Plus Home Therapy for Stroke Patients
Baseline characteristics by cohort
| Measure |
FitMi Plus
n=25 Participants
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.
|
FitMi Basic
n=25 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 14.7 • n=99 Participants
|
54.0 years
STANDARD_DEVIATION 13.0 • n=107 Participants
|
55.2 years
STANDARD_DEVIATION 13.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and One-Month Post-Treatment, at seven weeksA 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
Outcome measures
| Measure |
FitMi Plus
n=24 Participants
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.
|
FitMi Basic
n=24 Participants
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.
|
|---|---|---|
|
Change in Motor Activity Log
Amount of Use
|
0.60 score on a scale
Standard Deviation 0.53
|
0.40 score on a scale
Standard Deviation 0.39
|
|
Change in Motor Activity Log
Quality of Movement
|
0.64 score on a scale
Standard Deviation 0.48
|
0.44 score on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline and One-Month Post-Treatment, at seven weeksA 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
Outcome measures
| Measure |
FitMi Plus
n=25 Participants
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.
|
FitMi Basic
n=25 Participants
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.
|
|---|---|---|
|
Change in Upper Extremity Fugl-Meyer
|
2.0 score on a scale
Standard Deviation 3.3
|
1.0 score on a scale
Standard Deviation 2.8
|
Adverse Events
FitMi Plus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FitMi Basic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place