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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up t1 (day 12-14) - t0 (day 4-6)

Awards & highlights

Study Summary

This trial will help researchers understand if the BURT Upper Extremity Robot can help patients with stroke-related movement problems by providing more repetitions of movement than conventional therapy.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ t1 (day 12-14) - t0 (day 4-6)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~t1 (day 12-14) - t0 (day 4-6)

This trial's timeline: 3 weeks for screening, Varies for treatment, and t1 (day 12-14) - t0 (day 4-6) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

9 Hole Peg Test (9HPT)

Manual Muscle Testing (MMT)

Modified Ashworth Scale (MAS)

+1 more

Secondary outcome measures

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

0 / 3Eligibility criteria met

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

BURT (Robotic Rehabilitation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05401799 — N/A

Stroke Research Study Groups: Conventional Upper Extremity Neuroeducation, BURT Upper Extremity

Stroke Clinical Trial 2023: BURT Highlights & Side Effects. Trial Name: NCT05401799 — N/A

BURT (Robotic Rehabilitation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05401799 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial open to senior citizens?

"Complying with the stipulations of this clinical trial, individuals need to be between 18 and 115 years old in order to participate."

Answered by AI

What criteria do individuals need to fulfill in order to be eligible for this research project?

"For this medical trial, Sunnyview Rehabilitation Hospital is recruiting 148 stroke patients between 18 and 115 years old. The eligibility criteria necessitates that the patient must have experienced unilateral paralysis with a manual muscle testing score of 3/5 or less across their affected arm."

Answered by AI

Are there any opportunities for enrolment with this research project?

"The medical research trial is still open to participants, with the original posting of September 1st 2022 and a recent update on December 1st 2022. This information can be found at clinicaltrials.gov."

Answered by AI

What is the current participant count in this examination?

"Affirmative. Clinicaltrials.gov reveals that this medical experiment, originally posted on September 1st 2022, is actively seeking patients. In total, 148 individuals need to be enrolled from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BURT Efficacy in Improving Upper Extremity Strength and Function During Post-stroke Inpatient Rehabilitation

Casey Cowan 2022. "BURT Efficacy in Improving Upper Extremity Strength and Function During Post-stroke Inpatient Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05401799.