An interventional study of FINGER I and FINGER II in Cerebrovascular Accident, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-25.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
The purpose of this study is to determine the effectiveness of training hand movement using FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users to play computer games using those movements.
Robotic devices can be used to retrain movement after stroke. However, it is unclear how best to assist in movement. Providing physical assistance may improve the flow of proprioceptive information to the nervous system, which may help a person relearn to move a limb. On the other hand, assisting movement with a robot may cause a person to "slack", not trying as hard during therapy. This study will test the effect of different levels of assistance on recovery of finger function during robot-assisted therapy after stroke.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 31 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exclusion criteria that will prevent subjects from participating in the MRI:
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
Device: FINGER I · Device: 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
Device: FINGER I · Device: 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 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 II
Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed
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.
Time frame: From baseline to 1-month post therapy
Motor and Strength Measure Using Action Research Arm Test Measured as a Score
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.
Time frame: From baseline to 1-month post therapy
Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score
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.
Time frame: From baseline to 1-month post therapy
| Milestone | FINGER I | FINGER II |
|---|---|---|
| Started | 16 | 15 |
| Completed | 15 | 15 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| blocks | FINGER I | FINGER II |
|---|---|---|
| Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed | 2.3 ± 3.7 | 2.4 ± 4.6 |
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.
| scores on a scale | FINGER I | FINGER II |
|---|---|---|
| Motor and Strength Measure Using Action Research Arm Test Measured as a Score | 2.5 ± 3.7 | 3.5 ± 4.9 |
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.
| units on a scale | FINGER I | FINGER II |
|---|---|---|
| Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score | 3.7 ± 3.3 | 1.8 ± 1.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FINGER I | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| FINGER II | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | FINGER I | FINGER II | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 6 | 18 |
| >=65 years | 3 | 9 | 12 |
| Sex: Female, Male(Participants) | FINGER I | FINGER II | Total |
|---|---|---|---|
| Female | 6 | 11 | 17 |
| Male | 9 | 4 | 13 |
| Region of Enrollment(participants) | FINGER I | FINGER II | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
Plan to share: No
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University of California, Irvine