Cerebrovascular Accident
Conditions
Keywords
stroke, cerebrovascular accident, robot
Brief summary
The purpose of this study is to develop an upper extremity robotic training system for use by people with stroke to practice arm and hand movement in the clinic.
Detailed description
Each year in the U.S. over 400,000 people survive a stroke and approximately 80% of acute stroke survivors lose arm and hand movement skills. Movement impairments are typically treated with intensive, hands-on physical and occupational therapy for several weeks after the initial brain injury. Unfortunately, due to economic pressure on the U.S. health care system, stroke patients are receiving less therapy and going home sooner. Our goal for this study is to develop an upper extremity robotic training system for both acute and chronic stroke population to improve movement ability with intensive and repetitive movement in the clinic without continuous supervision from a therapist.
Interventions
DEVICEFunctional/ Multi-joints activities
Subjects participated in 4 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder), 3 days per week, 1 hour per day with the robotic exercise program focusing on functional tasks such as cleaning the windows, driving a steering wheel, grocery shopping, etc.
DEVICEIndividual Joint Training
Subjects participated in 4 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements focusing on one joint at a time.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 73 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 73 * Sustained single stroke at least three months previously * Minimal to moderate lost motor control of the arm after stroke
Exclusion criteria
* Concurrent severe medical problems * Severe cognitive dysfunction * Severe neglect or apraxia * Severe visual deficits * Significant subluxation of the shoulder * Presence of severe elbow or wrist contracture * Any metal implants or surgical clips or mechanical devices * Metallic hardware on scalp region * prior diagnosis of seizure and epilepsy * severe migraine headache * currently pregnant or lactating * claustrophobic * currently taking medication that lower seizure threshold
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box & Blocks Test | Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention. | We measured the Box and Blocks Test scores at baseline evaluation, after each intervention, and at the 3-month follow up evaluation. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Type I Robotic Therapy (Functional Activities Then Individual Joint Exercises) Robotic group (Type I)
Type I Robotic Group (Functional activities and individual joints): Subjects participate in 11 weeks of robotic training with the device: BONES (Biomimetic Orthosis Neurorehabilitation for Elbow and Shoulder), 3 days per week, 1 hour per day with the robotic exercise program involving multiple joints at the same time for the functional activities such as cleaning the window, driving a steering wheel, grocery shopping, etc; and then individual joint exercises focusing on one joint at a time with the individual joint exercises. | 10 |
| Type II Robotic Therapy (Individual Joints Exercises Then Functional Activities) Robotic group (Type II)
Type II Robotic therapy (Individual joints exercises then functional activities): Subjects participate in 11 weeks of training with the robotic device BONES, 3 days per week, 1 hour per day with a robot-assisted exercise program. The robotic exoskeleton assists in arm and hand movements as the patient perform individual joint exercises focusing on one joint at a time; and then functional activities like cleaning the window, driving a steering wheel, grocery shopping, etc for the functional activities. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Type II Robotic Therapy (Individual Joints Exercises Then Functional Activities) | Type I Robotic Therapy (Functional Activities Then Individual Joint Exercises) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 16 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 7 | 60 years STANDARD_DEVIATION 7 | 60 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Box & Blocks Test
We measured the Box and Blocks Test scores at baseline evaluation, after each intervention, and at the 3-month follow up evaluation. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.
Time frame: Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Functional Multi-joint Training Then Individual Joint Training | Box & Blocks Test | Baseline evaluation | 25 blocks | Standard Deviation 11 |
| Functional Multi-joint Training Then Individual Joint Training | Box & Blocks Test | Post 2nd Intervention | 31 blocks | Standard Deviation 11 |
| Functional Multi-joint Training Then Individual Joint Training | Box & Blocks Test | Post 1st Intervention | 29 blocks | Standard Deviation 18 |
| Functional Multi-joint Training Then Individual Joint Training | Box & Blocks Test | 3-month follow up evaluation | 28 blocks | Standard Deviation 5 |
| Individual Joint Training Then Functional Multi-joint Training | Box & Blocks Test | 3-month follow up evaluation | 46 blocks | Standard Deviation 9 |
| Individual Joint Training Then Functional Multi-joint Training | Box & Blocks Test | Baseline evaluation | 36 blocks | Standard Deviation 14 |
| Individual Joint Training Then Functional Multi-joint Training | Box & Blocks Test | Post 1st Intervention | 42 blocks | Standard Deviation 14 |
| Individual Joint Training Then Functional Multi-joint Training | Box & Blocks Test | Post 2nd Intervention | 43 blocks | Standard Deviation 13 |