Stroke
Conditions
Keywords
stroke, rehabilitation
Brief summary
The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.
Interventions
DEVICEHand & Wrist Assisting Robotic Device
Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks. In each treatment session, you will sit in a chair and have your weak hand attached to a mechanical device (the robot), which will help you open and close your hand. During the treatment, different types of objects (with varying shapes, sizes, and weight) will be placed into your hand. You will be given a variety of instructions related to the grasping, feeling, or identifying of the object in your hand. Sometimes these instructions will be given from the investigator and sometimes from the computer. You will often be asked to grasp, or release, each of these objects as best you can. You will also be asked to concentrate on the object in your hand. An example of what you may be asked to do is to name the object. During other times, you will play games, using the robot to control game parts on the computer screen. At other times, you will move your hand so that the robot can measure your hand function.
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years old 2. Had stroke between 11-26 weeks ago 3. Have some weakness in one of your wrists or hands due to stroke 4. Did not have too much disability prior to stroke 5. Do not have major depression
Exclusion criteria
1. Non-English speaking 2. If you have trouble keeping good attention 3. Pregnant, advanced liver, kidney, heart, or lung disease 4. Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke 5. Cannot undergo MRI scanning 6. Have history of brain surgery or seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test | change from baseline to 1 month post-end treatment, Intention To Treat | The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement. |
| Arm Motor Fugl-Meyer Test | change from baseline to 1 month post-end treatment, Intention To Treat | The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Therapy All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
Hand & Wrist Assisting Robotic Device: Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Active Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Action Research Arm Test
The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.
Time frame: change from baseline to 1 month post-end treatment, Intention To Treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Therapy | Action Research Arm Test | 4.1 units on a scale |
Primary
Arm Motor Fugl-Meyer Test
The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.
Time frame: change from baseline to 1 month post-end treatment, Intention To Treat
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Therapy | Arm Motor Fugl-Meyer Test | 3.7 units on a scale |