What side effects are associated with this type of intervention?

Robotic-assisted rehabilitation therapies, such as those using the Barrett Upper Extremity Robot (BURT), generally have mild side effects. These can include muscle soreness, fatigue, and temporary discomfort due to increased activity levels. Some patients may experience skin irritation from device contact or minor injuries if the equipment is not used correctly. However, these therapies are generally well-tolerated and are designed to minimize the risk of serious adverse events while promoting neuro re-education and functional recovery.

What prior FDA approvals exist?

The FDA has approved various treatments for stroke rehabilitation that focus on improving upper extremity function and mobility. One such treatment is the Barrett Upper Extremity Robot (BURT), which assists patients with both passive and active range of motion, provides adjustable resistance, and engages patients through video game activities for neuro re-education. This approach aims to enhance strength, fine motor coordination, and activities of daily living. Other FDA-approved treatments for stroke rehabilitation include robotic-assisted therapy devices and neuromodulation techniques, which similarly focus on improving motor function and patient engagement.

What other types of research exist?

Promising alternatives to the Barrett Upper Extremity Robot (BURT) for stroke patients in 2024 include: 1) The ArmeoSpring, which provides arm weight support and interactive exercises to improve motor function. 2) The InMotion ARM, a robotic system that offers intensive, repetitive therapy for upper limb rehabilitation. 3) The MyoPro, a powered orthosis that assists with arm and hand movements using the patient's own muscle signals. These devices offer similar functionalities such as passive and active range of motion assistance, adjustable resistance, and engaging therapeutic activities.

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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

No Placebo-Only Group

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 below

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I am 18 years old or older.

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I have had a stroke affecting one side of my brain.

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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:

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I have a neurological disorder.

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I have had a stroke and still experience effects from it.

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I have severe osteoporosis.

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I have had strokes affecting both sides of my brain.

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My shoulder is severely dislocated and cannot be supported by the device.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and t2(day 20-23) - t0 (day 4-6) for reporting.

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 more

Secondary study objectives

GG Scores for Mobility items

GG Scores for Self-Care Items

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met

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.