Trial Outcomes & Findings for FINGER Robot Therapy Study (NCT NCT02048826)
NCT ID: NCT02048826
Last Updated: 2021-03-25
Results Overview
The primary endpoint was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 seconds, from baseline to 1-month post-therapy. The higher the scores, the better arm and hand function indicated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
From baseline to 1-month post therapy
Results posted on
2021-03-25
Participant Flow
Participant milestones
| Measure |
FINGER I
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
FINGER III: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting III
|
FINGER II
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
FINGER III: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting III
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
FINGER I
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
FINGER III: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting III
|
FINGER II
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
FINGER III: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting III
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
FINGER Robot Therapy Study
Baseline characteristics by cohort
| Measure |
FINGER I
n=15 Participants
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
|
FINGER II
n=15 Participants
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to 1-month post therapyPopulation: The number of blocks participants able to pick up and place in a box in 60 seconds at one month follow up minus the number of blocks participants able to pick up and place in a box in 60 seconds at baseline.
The primary endpoint was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 seconds, from baseline to 1-month post-therapy. The higher the scores, the better arm and hand function indicated.
Outcome measures
| Measure |
FINGER I
n=15 Participants
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
|
FINGER II
n=15 Participants
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
|
|---|---|---|
|
Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed
|
2.3 blocks
Standard Deviation 3.7
|
2.4 blocks
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: From baseline to 1-month post therapyPopulation: The ARAT score at one-month post-therapy minus ARAT score at baseline on a 57 point scale.
We compared the change in Action Research Arm Test (ARAT) scores from the baseline evaluation to 1-month post-therapy evaluation. The ARAT is a 57-point scale, 0 being the minimum scoreand 57 being the maximum score, that measures upper extremity function, coordination, and dexterity. The higher scores indicate a better outcome.
Outcome measures
| Measure |
FINGER I
n=15 Participants
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
|
FINGER II
n=15 Participants
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
|
|---|---|---|
|
Motor and Strength Measure Using Action Research Arm Test Measured as a Score
|
2.5 scores on a scale
Standard Deviation 3.7
|
3.5 scores on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: From baseline to 1-month post therapyPopulation: Fugl-Meyer score at one-month post-therapy minus Fugl-Meyer score at baseline on a 66 point scale.
The primary outcome measure was the change in Upper Extremity Fugl-Meyer score on a scale of 0 to 66 at one-month post-therapy. The higher the scores, the better arm and hand function indicated.
Outcome measures
| Measure |
FINGER I
n=15 Participants
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
|
FINGER II
n=15 Participants
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program
FINGER I: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER II: FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
|
|---|---|---|
|
Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score
|
3.7 units on a scale
Standard Deviation 3.3
|
1.8 units on a scale
Standard Deviation 1.9
|
Adverse Events
FINGER I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FINGER II
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
Prof. David Reinkensmeyer
University of California at Irvine
Phone: 949-824-5218
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place