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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic group (Type I) | Experimental | Type I Robotic Therapy (Functional activities first) Participants in this group will participate in functional/task-oriented multi-joint training with the BONES robot first, followed by individual joint training with the BONES robot. A one-week break was provided between interventions. |
|
| Robotic group (Type II) | Active Comparator | Type II Robotic Therapy (Individual joints first) Participants in this group will participate in individual joint training with the BONES robot first, followed by functional/task-oriented multi-joint training with the BONES robot. A one-week break was provided between interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional/ Multi-joints activities | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David J Reinkensmeyer, Ph.D | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24354476 | Derived | Milot MH, Spencer SJ, Chan V, Allington JP, Klein J, Chou C, Bobrow JE, Cramer SC, Reinkensmeyer DJ. A crossover pilot study evaluating the functional outcomes of two different types of robotic movement training in chronic stroke survivors using the arm exoskeleton BONES. J Neuroeng Rehabil. 2013 Dec 19;10:112. doi: 10.1186/1743-0003-10-112. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Individual Joints and Functional Multi-joints Tasks | Robotic group(Type I) Type II Robotic therapy (Individual joints only): 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 play interactive computer games. |
| FG001 | Functional Multi-joints Activities and Individual Joints | Robotic group (Type II) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | blocks | Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Individual Joints | Robotic group(Type I) Type II Robotic therapy (Individual joints only): Subjects participate 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. Then, after one-week of a rest break, all subjects will return to participate in another 4 weeks of training with BONES again, 3 days per week with 1 hour per day, focusing on multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr David Reinkensmeyer | University of California Irvine | (949) 824-5218 | dreinken@uci.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Individual Joint Training | Device | 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. |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Individual Joint Training Then Functional Multi-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 which focuses on individual joint exercises, one joint at a time. Then, subjects performed the multi-joint functional training exercises for another 4 weeks with 3 days per week and 1 hour per day focusing on multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc. |
|
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Functional Multi-Joint Activities | Robotic group (Type II) Type I Robotic Group (Functional Multi-joint activities): Subjects participate 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 multi-joint activities such as cleaning the windows, driving a steering wheel, grocery shopping, etc. Then, after a one-week rest break, all subjects will return to participate in another 4 weeks of training with BONES again, 3 days per week with 1 hour per day, focusing on individual joint exercises with one joint at a time. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |