Cerebrovascular Accident
Conditions
Keywords
stroke
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFINGER 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
DEVICEFINGER 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
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 80 years of age * Have history of stroke affecting the arm, at least 6 months prior to enrollment * have arm and/or hand weakness as measured on a standard clinical scale * do not have active major psychological problems, or problems affecting the stroke-affected arm or hand besides the stroke * do not have active major brain disease other than the stroke * have absence of pain in the stroke-affected arm and hand
Exclusion criteria
* severe stiffness of the arm or hand as measured on a standard clinical scale * severe problems speaking or understanding speech as measured on a standard clinical scale * severe reduced level of consciousness * severe loss ability to sense movement of your limbs as measured on a standard clinical scale * currently pregnant * difficulty in understanding or complying with the instructions given by the researcher * inability to perform the experimental task that will be studied * increased pain with movement of the stroke-affected arm or hand
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed | From baseline to 1-month post therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor and Strength Measure Using Action Research Arm Test Measured as a Score | From baseline to 1-month post therapy | 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. |
| Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score | From baseline to 1-month post therapy | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | FINGER I | FINGER II | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 9 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 6 Participants | 18 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 17 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FINGER I | Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed | 2.3 blocks | Standard Deviation 3.7 |
| FINGER II | Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed | 2.4 blocks | Standard Deviation 4.6 |
Secondary
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
Population: The ARAT score at one-month post-therapy minus ARAT score at baseline on a 57 point scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FINGER I | Motor and Strength Measure Using Action Research Arm Test Measured as a Score | 2.5 scores on a scale | Standard Deviation 3.7 |
| FINGER II | Motor and Strength Measure Using Action Research Arm Test Measured as a Score | 3.5 scores on a scale | Standard Deviation 4.9 |
Secondary
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
Population: Fugl-Meyer score at one-month post-therapy minus Fugl-Meyer score at baseline on a 66 point scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FINGER I | Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score | 3.7 units on a scale | Standard Deviation 3.3 |
| FINGER II | Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score | 1.8 units on a scale | Standard Deviation 1.9 |