An interventional study of Functional/ Multi-joints activities and Individual Joint Training in Cerebrovascular Accident, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 18 Years to 73 Years. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 20 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:
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.
Device: Functional/ Multi-joints activities · Device: Individual Joint Training
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.
Device: Functional/ Multi-joints activities · Device: Individual Joint Training
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.
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.
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.
| Milestone | Individual Joints and Functional Multi-joints Tasks | Functional Multi-joints Activities and Individual Joints |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| blocks | Functional Multi-joint Training Then Individual Joint Training | Individual Joint Training Then Functional Multi-joint Training |
|---|---|---|
| Baseline evaluation | 25 ± 11 | 36 ± 14 |
| Post 1st Intervention | 29 ± 18 | 42 ± 14 |
| Post 2nd Intervention | 31 ± 11 | 43 ± 13 |
| 3-month follow up evaluation | 28 ± 5 | 46 ± 9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Individual Joints | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Functional Multi-Joint Activities | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Type I Robotic Therapy (Functional Activities Then Individual Joint Exercises) | Type II Robotic Therapy (Individual Joints Exercises Then Functional Activities) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 9 | 16 |
| >=65 years | 3 | 1 | 4 |
| Age, Continuous(years) | Type I Robotic Therapy (Functional Activities Then Individual Joint Exercises) | Type II Robotic Therapy (Individual Joints Exercises Then Functional Activities) | Total |
|---|---|---|---|
| Mean | 60 ± 7 | 60 ± 7 | 60 ± 7 |
| Sex: Female, Male(Participants) | Type I Robotic Therapy (Functional Activities Then Individual Joint Exercises) | Type II Robotic Therapy (Individual Joints Exercises Then Functional Activities) | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 4 | 6 | 10 |
| Region of Enrollment(participants) | Type I Robotic Therapy (Functional Activities Then Individual Joint Exercises) | Type II Robotic Therapy (Individual Joints Exercises Then Functional Activities) | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
Plan to share: No
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University of California, Irvine