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Robotic Rehabilitation Device
BURT Therapy for Stroke
N/A
Recruiting
Led By Casey Cowan, MS OTR/L
Research Sponsored by Sunnyview Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
>/= 18 years
Unilateral stroke
Must not have
Comorbid neurological disorders
Prior stroke with residual deficits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up t2(day 20-23) - t0 (day 4-6)
Awards & highlights
Summary
This trial tests if the Barrett Upper Extremity Robot (BURT) can be used effectively in a rehab center for stroke patients. BURT uses video games to help patients move their arms and hands more often and with more feedback than regular therapy. The study will see if BURT improves patients' strength, coordination, and daily activities more than traditional methods.
Who is the study for?
This trial is for adults over 18 who are inpatients at Sunnyview Rehabilitation Hospital, have had a stroke affecting one side of their body, and can't move the affected arm well (muscle strength less than 'fair'). They must be able to sit for 30 minutes and follow simple instructions. People with severe shoulder issues, osteoporosis, previous strokes or other neurological disorders, or those not expected to stay at least 15 days cannot join.
What is being tested?
The study tests if using the Barrett Upper Extremity Robot (BURT) during rehab after a stroke improves arm strength and function more than standard therapy. BURT offers high-repetition exercises through video games that adapt to patient fatigue. Participants will either receive this new robotic therapy or conventional occupational therapy.
What are the potential side effects?
Since BURT is a non-invasive rehabilitation robot designed to assist with physical movements without drugs or surgery, it generally has minimal side effects. However, some patients might experience discomfort due to repetitive motions or fatigue from participating in the activities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have had a stroke affecting one side of my brain.
Select...
My arm is weak, scoring 3 or less on a strength test.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a neurological disorder.
Select...
I have had a stroke and still experience effects from it.
Select...
I have severe osteoporosis.
Select...
I have had strokes affecting both sides of my brain.
Select...
My shoulder is severely dislocated and cannot be supported by the device.
Select...
I cannot sit for 30 minutes without discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ t2(day 20-23) - t0 (day 4-6)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~t2(day 20-23) - t0 (day 4-6)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
9 Hole Peg Test (9HPT)
Manual Muscle Testing (MMT)
Modified Ashworth Scale (MAS)
+1 moreSecondary study objectives
GG Scores for Mobility items
GG Scores for Self-Care Items
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BURT Upper ExtremityExperimental Treatment2 Interventions
As part of routine therapy, 74 patients will receive up to 5 sessions per week of BURT UE therapy in place of conventional neuro re-education. Patients in this arm of the study will receive any conventional therapy during the remainder of their treatment sessions. When using BURT, therapists will track the activity, level of assistance and time provided in a tracking sheet, as well as document any adverse events that may occur.
Group II: Conventional Upper Extremity NeuroeducationActive Control1 Intervention
74 patients will receive the standard occupational therapy sessions that they would normally receive during their IRF stay. UE neuroeducation sessions are typically focused on improving strength and mobility of the upper arm. Clinicians will not be given instructions on how to run their sessions, however they will not be allowed to use BURT. Other devices that would normally be used during neuro-educational sessions (including X-cite, electrical stimulation and RT-300) will be allowed for use in this group. The therapists will track the activity, level of assistance and time provided in a tracking sheet, as well as document any adverse events that may occur
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Stroke rehabilitation often involves therapies that focus on improving motor function and neuroplasticity. Treatments like the Barrett Upper Extremity Robot (BURT) assist with both passive and active range of motion, providing adjustable resistance to help strengthen muscles and improve coordination.
Engaging patients through video game activities offers active proprioceptive, vibrational, visual, and auditory feedback, which is crucial for neuro re-education. These mechanisms are important because they help stroke patients regain upper extremity strength, fine motor skills, and overall mobility, thereby enhancing their ability to perform daily activities and improving their quality of life.
Find a Location
Who is running the clinical trial?
Sunnyview Rehabilitation HospitalLead Sponsor
3 Previous Clinical Trials
196 Total Patients Enrolled
3 Trials studying Stroke
196 Patients Enrolled for Stroke
Gaylord HospitalUNKNOWN
1 Previous Clinical Trials
86 Total Patients Enrolled
Casey Cowan, MS OTR/LPrincipal InvestigatorSunnyview Rehabilitation Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It has been more than 30 days since my last stroke.I have a neurological disorder.I am currently undergoing prism adaptation treatment.I have had a stroke and still experience effects from it.I have severe osteoporosis.I have had strokes affecting both sides of my brain.I struggle to follow simple instructions.My shoulder is severely dislocated and cannot be supported by the device.I am 18 years old or older.I have had a stroke affecting one side of my brain.My arm is weak, scoring 3 or less on a strength test.You have arm problems that could make it hard for you to get better with the treatment.I cannot sit for 30 minutes without discomfort.Serious lack of care or attention.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional Upper Extremity Neuroeducation
- Group 2: BURT Upper Extremity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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