Upper Extremity Rehabilitation With the BURT Robotic Arm

Study Overview
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Brief Summary
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The overall objective of the proposed study is to carry out usability and design-evaluation assessments of the BURT robotic device for delivering long-term intervention in stroke survivors. The BURT is an upper extremity robotic device that enables the user to see and feel engaging games that encourage intensive therapy. The investigators intend to recruit up to 10 stroke survivors over the course of the study. Participants will train their arm with the BURT for 18 sessions over approximately 6 weeks then participate in a question/answer formatted discussion with research staff to discuss the usability of the device. The investigators will also assess participant's arm function at baseline and after the training sessions.

Official Title
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Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study

Conditions
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Stroke, Hemiparesis

Intervention / Treatment
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* Device: Arm motor function retraining with BURT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female, age 18-80; Having had a stroke (ischemic or hemorrhagic) at least 6 months prior to study Moderate to severe upper-limb motor impairments (score of 15-45 out of 66 on the Fugl- Meyer Scale); Community dwelling; Able to physically fit in the device. Exclusion Criteria: Current participation in rehabilitation program targeting upper extremity function; Cognitive impairment resulting to inability to follow instructions or inability to sustain attention for more than 10 minutes; Visual impairments not corrected with lenses (visual loss); Aphasia sufficient to limit comprehension and completion of the treatment protocol; No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy; Increased muscle tone (passive movement is difficult); Previous diagnosis of neurological diseases other than stroke; Other conditions affecting function of the stroke affected upper limb; Individuals who present with the following: open wounds, fragile skin, active infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will receive the same intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm motor function retraining with BURT<br>All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities. | Device: Arm motor function retraining with BURT<br>* Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Fugl-Meyer Upper Extremity Scores | Assessment of upper extremity impairments. Individual items of the scale are summed for a total score ranking from 0 to 66. Higher scores indicate better outcomes. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Goal Attainment Scale Scores | Standardized measure of goals selection and scaling to calculate the extend to which the participant's goals are met. The Goal Attainment Scale ranges from -2 to +2. Positive scores indicates goals are better than expected, score of 0 indicates goals are met and negative scores indicates goals aren't met. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, hemiparesis, Robotic