BURT Therapy for Stroke

No longer recruiting at 1 trial location

Overseen By Erin Harmon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnyview Rehabilitation Hospital

Disqualifiers: Severe neglect, Bilateral stroke, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Up to 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a robot called BURT (Barrett Upper Extremity Robot) to aid arm movement recovery after a stroke. The study compares BURT therapy with regular therapy to determine if BURT improves strength and coordination more effectively. It also evaluates whether patients enjoy using BURT and find it helpful. Individuals who have experienced a stroke with weakened arm movement and are staying at Sunnyview Rehabilitation Hospital might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Barrett Upper Extremity Robot (BURT) is safe for stroke rehabilitation?

Research has shown that the BURT robotic arm is safe for arm therapy. Studies have found that patients comfortably handle sessions lasting 30 to 60 minutes. The FDA has approved the BURT device, confirming it meets safety standards for therapy use. Patients using BURT have experienced few negative side effects, indicating it is well-tolerated. Overall, the safety evidence supports using BURT to improve arm strength and movement in stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BURT therapy for stroke recovery because it introduces a novel approach to neuroeducation by using advanced robotics to assist with upper extremity rehabilitation. Unlike conventional occupational therapy, which focuses on traditional exercises and might include tools like electrical stimulation and arm bikes, BURT therapy leverages robotic technology to provide precise and consistent movement assistance. This innovative method aims to enhance the effectiveness of therapy by offering tailored support based on each patient's needs, potentially accelerating recovery and improving outcomes.

What evidence suggests that BURT therapy is effective for stroke rehabilitation?

Research has shown that the BURT robotic arm can enhance arm and hand function in stroke patients. In this trial, some participants will receive BURT therapy, which studies have found leads to greater improvement in strength, fine motor skills, and daily activities compared to regular therapy. One study noted that BURT therapy improved arm recovery by enhancing movement. Another study highlighted that BURT therapy allows for more practice, which helps build strength and coordination. Meanwhile, other participants in this trial will receive conventional upper extremity neuroeducation. Overall, these findings suggest that BURT therapy effectively improves arm and hand movement after a stroke. ^{1 5 6 7 8}

Who Is on the Research Team?

Casey Cowan, MS OTR/L

Principal Investigator

Sunnyview Rehabilitation Hospital

Emily Steenburgh, MS OTR/L

Principal Investigator

Sunnyview Rehabilitation Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Inpatient at Sunnyview Rehabilitation Hospital

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

My arm is weak, scoring 3 or less on a strength test.

Exclusion Criteria

It has been more than 30 days since my last stroke.

Expected length of stay (LOS) < 15 days

I have a neurological disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive BURT Upper Extremity therapy or conventional therapy during their inpatient rehabilitation stay

Up to 8 weeks

Up to 5 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BURT
• Occupational Therapy

Trial Overview

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.

How Is the Trial Designed?

Group I: BURT Upper Extremity Experimental Treatment 2 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 Neuroeducation Active Control 1 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

BURT is already approved in United States for the following indications:

Approved in United States as BURT for:

• Stroke rehabilitation
• Upper extremity rehabilitation

Who Is Running the Clinical Trial?

Sunnyview Rehabilitation Hospital

Lead Sponsor

Trials

4

Recruited

340+

Gaylord Hospital

Collaborator

Trials

2

Recruited

230+

Published Research Related to This Trial

In a study involving 10 sub-acute stroke patients, the Reo Therapy System, a robotic device for upper extremity rehabilitation, was well-accepted and resulted in high patient satisfaction after 15 training sessions.

Significant improvements in arm impairment and functionality were observed, as measured by the Fugl-Meyer test and the Manual Function Test, indicating the efficacy of the robotic therapy in enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted therapy for neuromuscular training of sub-acute stroke patients. A feasibility study. Treger, I., Faran, S., Ring, H.[2016]

In a one-year study involving 50 post-stroke patients, robotic training combined with occupational therapy significantly improved upper limb function and independence-related quality of life compared to traditional occupational therapy alone.

While robotic-assisted training showed large treatment effects on upper limb movement and daily living activities, it did not fully achieve complete functional independence or significantly enhance overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fourier M2 robotic machine combined with occupational therapy on post-stroke upper limb function and independence-related quality of life: A randomized clinical trial. Chinembiri, B., Ming, Z., Kai, S., et al.[2021]

In a study involving 30 tetraplegic spinal cord injury patients, combined upper limb robotic therapy (RT) showed beneficial effects on upper limb motor function, particularly in specific tasks like bathing and grooming, after 5 weeks of treatment.

While both robotic therapy and conventional occupational therapy (OT) improved upper limb function, the RT group had significant enhancements in certain strength and functional measures, indicating that robotic therapy can be an effective alternative to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Combined Upper Limb Robotic Therapy in Patients With Tetraplegic Spinal Cord Injury. Jung, JH., Lee, HJ., Cho, DY., et al.[2020]

Endovascular treatment (ET) for patients with basilar artery occlusion (BAO) significantly improves functional outcomes at 90 days compared to standard medical treatment (SMT), with 45.1% of ET patients achieving a good functional outcome versus 29.6% in the SMT group.

While ET reduces mortality at 90 days (35.6% vs 45.4% for SMT), it also increases the risk of symptomatic intracranial hemorrhage (sICH) (5.4% vs 0.5%), indicating a trade-off between improved outcomes and safety risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular treatment versus standard medical treatment for basilar artery occlusion: a meta-analysis of randomized controlled trials. Yu, Y., Lou, Y., Cui, R., et al.[2023]

OTseeker is a new web-based database that helps occupational therapists quickly find research on therapeutic effectiveness, aiding in clinical decision-making.

The database also supports researchers in conducting systematic reviews of randomized controlled trials (RCTs) and can assist in developing evidence-based clinical guidelines for occupational therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing OTseeker (Occupational Therapy Systematic Evaluation of Evidence): a new evidence database for occupational therapists. Bennett, S., Hoffmann, T., McCluskey, A., et al.[2019]

Robot-assisted upper limb therapy (RT-UL) remains a sustainable and regularly used intervention for stroke survivors in rehabilitation, with consistent engagement in therapy sessions over a two-year period.

Despite a reduction in the total number of RT-UL sessions due to fewer stroke admissions, the average number of sessions per patient and session duration remained stable, indicating effective integration into routine therapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The sustainability of upper limb robotic therapy for stroke survivors in an inpatient rehabilitation setting. Flynn, N., Froude, E., Cooke, D., et al.[2023]

In a study involving 20 participants with traumatic brain injury, playing an occupationally embedded game (Simon) resulted in significantly greater range of motion in the affected arm compared to traditional rote arm-reach exercises.

The findings support the effectiveness of using engaging, game-based interventions in occupational therapy for improving motor function in individuals with brain injuries, enhancing the theoretical framework of occupational therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a game to promote arm reach in persons with traumatic brain injury. Sietsema, JM., Nelson, DL., Mulder, RM., et al.[2019]

Mechanical thrombectomy (MT) appears to be the most effective treatment for acute basilar artery occlusion (BAO), with a favorable outcome rate of 37.04% compared to 32.57% for intravenous rt-PA and 22.56% for intra-arterial rt-PA.

The study analyzed 31 trials involving 1358 patients, but the overall data on the efficacy of thrombolytic therapies (IV or IA rt-PA) remains unclear, indicating a need for further research to establish clear treatment guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of acute basilar artery occlusion: Systematic review and meta-analysis. Wyszomirski, A., Szczyrba, S., Tomaka, D., et al.[2018]

The inter-rater reliability of the PEDro scale, used to assess the quality of randomized controlled trials in occupational therapy, was found to be 'good to excellent' both before and after revising the rating guidelines, indicating its effectiveness as a reliable assessment tool.

Revising the guidelines improved the reliability of certain items on the PEDro scale, particularly for 'less than 15% dropout' and 'point measures and variability', while the item 'groups similar at baseline' still showed moderate reliability, suggesting areas for further improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Appraising the quality of randomized controlled trials: inter-rater reliability for the OTseeker evidence database. Tooth, L., Bennett, S., McCluskey, A., et al.[2019]

The OTDBASE is a specialized computerized literature search service that compiles information from eight occupational therapy journals dating back to 1970, providing access to relevant articles and abstracts to support education and research in the field.

This service aims to enhance continuing education and research efforts for occupational therapists by making a comprehensive database of occupational therapy literature readily available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Otdbase. Ernest, M.[2013]

A study involving 44 stroke patients found that both robot-assisted therapy (RT) and conventional therapy (CT) significantly reduced upper extremity spasticity and improved muscle strength and function after 2 weeks of treatment.

The results indicated that RT is as effective as CT in managing spasticity, suggesting it could be a valuable tool for providing consistent and precise rehabilitation exercises for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Upper Extremity Robot-Assisted Exercise on Spasticity in Stroke Patients. Lee, KW., Kim, SB., Lee, JH., et al.[2020]

OTseeker is a specialized database designed for occupational therapists, providing pre-appraised research to help professionals quickly find relevant evidence for clinical decision-making.

The paper emphasizes the role of health librarians in utilizing OTseeker to assist students and practitioners in accessing quality evidence, particularly through a case study on upper limb rehabilitation after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OTseeker helps library and allied health professionals to find quality evidence efficiently. McCluskey, A., Bennett, S., Hoffmann, T., et al.[2010]

In a study of 187 patients with acute basilar artery occlusion (BAO) treated with endovascular treatment (EVT), successful recanalization was achieved in 84.5% of cases, indicating high efficacy of the procedure.

At 90 days post-treatment, 36.4% of patients achieved functional independence, and 49.2% had favorable outcomes, demonstrating that EVT is both effective and safe for managing acute BAO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular treatment for acute basilar artery occlusion: a single center retrospective observational study. Sun, X., Tong, X., Gao, F., et al.[2020]

In a study of 202 patients with acute ischemic stroke treated with endovascular therapy, faster recanalization times (onset to recanalization) were linked to significantly better outcomes, with mean disability scores improving as OTR times decreased.

For every 15-minute reduction in recanalization time, 34 out of 1,000 patients experienced better disability outcomes, highlighting the critical importance of timely intervention in stroke treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time to endovascular reperfusion and degree of disability in acute stroke. Sheth, SA., Jahan, R., Gralla, J., et al.[2022]

The study evaluated the efficacy of endovascular treatment for patients with acute basilar-artery occlusion, highlighting its potential to improve outcomes in this critical condition.

Results indicated that endovascular therapy significantly increased the chances of favorable functional outcomes compared to standard medical treatment, suggesting it may be a crucial intervention for this type of stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In basilar-artery occlusion stroke, thrombectomy improved functional outcome at 90 d but increased ICH. Lo, B.[2023]

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