BURT Therapy for Stroke
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sunnyview Rehabilitation Hospital
Disqualifiers: Severe neglect, Bilateral stroke, Others
No Placebo Group
Trial Summary
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.
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?
Is BURT Therapy for Stroke safe for humans?
How is BURT Therapy for Stroke different from other treatments?
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
I am 18 years old or older.
Inpatient at Sunnyview Rehabilitation Hospital
I have had a stroke affecting one side of my brain.
See 1 more
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.
See 9 more
Trial 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 (Robotic Rehabilitation Device)
- Occupational Therapy (Other)
Trial OverviewThe 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
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
BURT is already approved in United States for the following indications:
🇺🇸 Approved in United States as BURT for:
- Stroke rehabilitation
- Upper extremity rehabilitation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sunnyview Rehabilitation HospitalSchenectady, NY
Gaylord HospitalWallingford, CT
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Who Is Running the Clinical Trial?
Sunnyview Rehabilitation HospitalLead Sponsor
Gaylord HospitalCollaborator
References
The sustainability of upper limb robotic therapy for stroke survivors in an inpatient rehabilitation setting. [2023]To investigate the sustainability of Robot-assisted upper limb therapy (RT-UL) as part of routine occupational therapy and physiotherapy clinical practice.
Effects of Combined Upper Limb Robotic Therapy in Patients With Tetraplegic Spinal Cord Injury. [2020]To confirm the effects of combined upper limb robotic therapy (RT) as compared to conventional occupational therapy (OT) in tetraplegic spinal cord injury (SCI) patients and to suggest the optimized treatment guidelines of combined upper limb RT.
The use of a game to promote arm reach in persons with traumatic brain injury. [2019]This study tested a principle of occupational therapy and motor learning theory in the context of neurodevelopmental treatment techniques. Ten trials of occupationally embedded intervention (playing Simon, a computer-controlled game) were compared with 10 trials of rote arm-reach exercise. A counterbalanced design was structured so that each subject experienced each condition one week apart. Subjects were 17 men and 3 women with traumatic brain injury who exhibited mild to moderate spasticity in the upper extremity. Maximum distance from hip to wrist during active reach of the affected extremity was measured by digitization of videotape with the Motion Analysis EV-3D system. Results indicated that the use of the game elicited significantly more range of motion than the rote exercise (t (19) = 5.77, p
Effect of Upper Extremity Robot-Assisted Exercise on Spasticity in Stroke Patients. [2020]To determine the efficacy of a stretching and strengthening exercise program using an upper extremity robot, as compared with a conventional occupational therapy program for upper extremity spasticity in stroke patients.
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]Most post-stroke patients experience upper limb functionality challenges. Emergent therapies using upper limb-based robot machines present opportunities to resolve the limitations inherent in Occupational therapy such as increased therapist-patient exhaustion, monotonous methods, and so forth. The aim of this parallel trial was to compare the effects of the upper limb robotic training with matched Occupational therapy training on upper limb function and independence-related quality of life in post-stroke patients within the Brunnstrom arm motor recovery stages 1 to 4. During one-year (2018-2019), 50 post-stroke patients were enrolled and randomly assigned to 2 groups; robot and Occupational therapy (n = 25) and Occupational therapy (n = 25). Both groups were trained for 50-70 minutes per day, 5 days a week for 6 weeks. The Chinese-adapted Fugl-Meyer Assessment-Upper Extremity (FMA-UE) was the primary outcome measure. The secondary outcome measures were the Brunnstrom Recovery Stages Scale (BRS) and the Chinese-adapted Barthel Index (BI). The treatment effect sizes of both groups were large in the following variables; transfers (1), BI total score (2.2), FMA-UE upper limb (1.1), wrist (1.8), elbow (1), fingers (0.9), and FMA-UE total scores (1.4). The treatment group in comparison to the control group had larger BRS changes, significant improvements in upper limb function, and partial independence in activities of daily living during the baseline to post-treatment period. Robotic-assisted training with occupational therapy may improve the upper limb movement foundation blocks; however, it does not translate into complete functional independence and improved quality of life. This study has been registered at the ISRCTN registry, https://doi.org/10.1186/ISRCTN84804731.
Appraising the quality of randomized controlled trials: inter-rater reliability for the OTseeker evidence database. [2019]'OTseeker' is an online database of randomized controlled trials (RCTs) and systematic reviews relevant to occupational therapy. RCTs are critically appraised and rated for quality using the 'PEDro' scale. We aimed to investigate the inter-rater reliability of the PEDro scale before and after revising rating guidelines.
Otdbase. [2013]This article describes the rationale behind the development of an "only occupational therapy" computerized literature search service. OTDBASE, the clinically-oriented index and data base, contains all relevant information about all articles from eight occupational therapy (OT) journals from 1970 to the present and includes up to 10 lines of abstract per article. The service was developed for purposes of contributing to continuing education and research efforts in occupational therapy.
Introducing OTseeker (Occupational Therapy Systematic Evaluation of Evidence): a new evidence database for occupational therapists. [2019]This clinical scenario illustrates how OTseeker can be used by occupational therapists to locate research that may inform clinical decisions. Beyond the clinical arena, this database also has potential to greatly enhance the ability of researchers to perform systematic reviews of RCTs and eventually, development of clinical guidelines. In conclusion, OTseeker is a new Web-based database that provides fast access to evidence of therapeutic effectiveness for clinicians, academics, and students, as well as consumers and providers of occupational therapy services. OTseeker will be able to be used by clinicians to guide dinical practice, by researchers to perform systematic reviews of RCTs, by students, and by consortiums of stakeholders to develop evidence-based guidelines for occupational therapy practice.
Robot-assisted therapy for neuromuscular training of sub-acute stroke patients. A feasibility study. [2016]Several studies have described the contribution of robotics technology in providing effective treatment options for improving upper-extremity functions in patients with hemiparesis following stroke. The aim of this study was to conduct a preliminary assessment of patient acceptance of an upper extremity robot, the Reo Therapy System (Motorika Ltd., Israel), developed specifically for neuromuscular training of upper extremities for use in rehabilitation centers and outpatient clinics.
OTseeker helps library and allied health professionals to find quality evidence efficiently. [2010]Research is essential for evidence-based practice yet many health professionals do not have enough time to find research. Studies relevant to occupational therapists can be particularly difficult to find. Most search engines are broad and return a large number of irrelevant articles. Occupational Therapy Systematic Evaluation of Evidence (OTseeker) is an occupational therapy database available at http://www.otseeker.com. Developed by Australian occupational therapists, the resource aims to increase access to research and support clinical decision making. This discipline-specific database contains pre-appraised information from a variety of sources and decreases the time required to locate best evidence.
Endovascular treatment versus standard medical treatment for basilar artery occlusion: a meta-analysis of randomized controlled trials. [2023]Acute ischemic stroke caused by basilar artery occlusion (BAO) is devastating, but the optimal treatment for patients with BAO remains controversial. In this study, the authors aimed to investigate the safety and efficacy of endovascular treatment (ET) versus standard medical treatment (SMT) in patients with BAO.
Endovascular treatment for acute basilar artery occlusion: a single center retrospective observational study. [2020]Endovascular treatment (EVT) is now considered the gold standard for select patient populations with anterior circulation stroke; however, data on the treatment of posterior circulation stroke are less clear. This study aims to determine the characteristics and treatment outcomes of patients with acute basilar artery occlusion (BAO) and to evaluate the effectiveness and safety of EVT for patients with acute BAO in a high-volume stroke center.
Treatment of acute basilar artery occlusion: Systematic review and meta-analysis. [2018]Acute basilar artery occlusion (BAO) results in strokes characterized by poor outcome. Intravenous and intraarterial thrombolysis with rt-PA (IV rt-PA and IA rt-PA, respectively) and mechanical thrombectomy (MT) are the most commonly used techniques to treat BAO, but their efficacy remains unclear. Unlike in previous papers, we compared all three methods of the treatment in a single work, including an update of meta-analysis regarding each of the three therapeutic approaches with recent trials.
Time to endovascular reperfusion and degree of disability in acute stroke. [2022]Faster time from onset to recanalization (OTR) in acute ischemic stroke using endovascular therapy (ET) has been associated with better outcome. However, previous studies were based on less-effective first-generation devices, and analyzed only dichotomized disability outcomes, which may underestimate the full effect of treatment.
In basilar-artery occlusion stroke, thrombectomy improved functional outcome at 90 d but increased ICH. [2023]Label="SOURCE CITATION">Tao C, Nogueira RG, Zhu Y, et al. Trial of endovascular treatment of acute basilar-artery occlusion. N Engl J Med. 2022;387:1361-72. 36239644.