Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Device: Functional/ Multi-joints activities
* Device: Individual Joint Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic group (Type I)<br>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<br>* 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.<br>Device: Individual Joint Training<br>* 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.<br>|
| Active Comparator: Robotic group (Type II)<br>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<br>* 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.<br>Device: Individual Joint Training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, cerebrovascular accident, robot