BURT Therapy for Stroke

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

82 Participants Needed

Trial Summary

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 data supports the effectiveness of the BURT Therapy for Stroke treatment?

Research shows that combining robotic therapy with occupational therapy can improve arm movement and partial independence in daily activities for stroke patients, although it may not lead to complete functional independence. ^{1 2 3 4 5}

Is BURT Therapy for Stroke safe for humans?

A study on robot-assisted therapy for stroke patients found that using an upper extremity robot for rehabilitation was generally well-accepted by patients, suggesting it is safe for human use. ^{6 7 8 9 10}

How is BURT Therapy for Stroke different from other treatments?

BURT Therapy for Stroke is unique because it involves the use of the Barrett Upper Extremity Robot, which is a robotic device designed to assist with arm rehabilitation, making it different from traditional stroke treatments that typically focus on medication or manual therapy. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Casey Cowan, MS OTR/L

Principal Investigator

Sunnyview Rehabilitation Hospital

Emily Steenburgh, MS OTR/L

Principal Investigator

Sunnyview Rehabilitation Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The sustainability of upper limb robotic therapy for stroke survivors in an inpatient rehabilitation setting. [2023]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of Combined Upper Limb Robotic Therapy in Patients With Tetraplegic Spinal Cord Injury. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

The use of a game to promote arm reach in persons with traumatic brain injury. [2019]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of Upper Extremity Robot-Assisted Exercise on Spasticity in Stroke Patients. [2020]

5. England 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Appraising the quality of randomized controlled trials: inter-rater reliability for the OTseeker evidence database. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Otdbase. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Introducing OTseeker (Occupational Therapy Systematic Evaluation of Evidence): a new evidence database for occupational therapists. [2019]

9. Italy pubmed.ncbi.nlm.nih.gov

Robot-assisted therapy for neuromuscular training of sub-acute stroke patients. A feasibility study. [2016]

10. England pubmed.ncbi.nlm.nih.gov

OTseeker helps library and allied health professionals to find quality evidence efficiently. [2010]

11. United States pubmed.ncbi.nlm.nih.gov

Endovascular treatment versus standard medical treatment for basilar artery occlusion: a meta-analysis of randomized controlled trials. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Endovascular treatment for acute basilar artery occlusion: a single center retrospective observational study. [2020]

13. Poland pubmed.ncbi.nlm.nih.gov

Treatment of acute basilar artery occlusion: Systematic review and meta-analysis. [2018]

14. United States pubmed.ncbi.nlm.nih.gov

Time to endovascular reperfusion and degree of disability in acute stroke. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

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