StrokeNCT05401799
BURT Efficacy in Improving Upper Extremity Strength and Function During Post-stroke Inpatient Rehabilitation
A study testing BURT and Other Occupational Therapy in people with Stroke and Stroke, Acute, run by Sunnyview Rehabilitation Hospital at 2 sites in United States.
Trial summary
The Barrett Upper Extremity Robot (BURT) is an FDA-approved upper extremity robot that assists patients with both passive and active range of motion while providing adjustable resistance (Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/). Read more about this study
- Who is it for?
- Ages 18 to 115 years
- Conditions the study is for
- Stroke, Stroke, Acute, Cerebral Vascular Accident
- What is being tested?
- BURT and Other Occupational Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2022to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 115 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient at Sunnyview Rehabilitation Hospital
- >/= 18 years
- Unilateral stroke
- UE paresis affected arm with 3-/5 or less manual muscle testing throughout
Who cannot join
- >30 days post stroke
- Severe Neglect
- Bilateral stroke
- Prior stroke with residual deficits
- Patients receiving prism adaptation treatment
- Comorbid neurological disorders
Show all 12Show fewer
- Upper limb comorbidities that could limit functional improvement (UE arthritis pain, UE fracture, fixed contracture not allowing for proper device alignment)
- Severe shoulder subluxation that cannot be accommodated by the device
- Severe osteoporosis
- Unable to follow simple directions
- Unable to tolerate sitting 30 minutes
- Expected length of stay (LOS) < 15 days.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sunnyview Rehabilitation Hospital
Schenectady, New York, 12308
Gaylord Hospital
Wallingford, Connecticut, 06492
About this study
Official title: Efficacy of the Barrett Upper Extremity Robot (BURT) for Improving Upper Extremity Strength and Function During Inpatient Rehabilitation Following Stroke.
The Barrett Upper Extremity Robot (BURT) is an FDA-approved upper extremity robot that assists patients with both passive and active range of motion while providing adjustable resistance (Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/). Activities are directed by therapists and encourage patient involvement through video game activities providing active proprioceptive, vibrational, visual and auditory feedback. Engaging and colorful games are beneficial in holding patients' interest, and gravity assistance may also allow for increased repetition in the face of patient fatigue.
In this prospective study, the investigators will determine if a standardized BURT Upper Extremity (UE) program can be consistently implemented within an acute inpatient rehabilitation facility (IRF). In addition, the investigators will see if patients who receive BURT have improved UE mobility and function as a result. The investigators will also study the perceived enjoyment and value of the intervention by patients, and perceived value by therapists.
Read more
Because BURT therapy is able to provide more repetitions of upper extremity movement in a shorter length of time than conventional therapy, the investigators hypothesize that patients who participate in neuro re-education activities using BURT will achieve greater improvements in strength, upper extremity function, fine motor coordination, activities of daily living and mobility during their time in an IRF than patients receiving conventional therapy.
In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or BURT therapy. Meaningful clinical benchmarks for upper extremity function, tone, fine motor coordination, activities of daily living and mobility will be assessed using the Upper Extremity Motor Assessment Scale (UE-MAS)(Zelter, 2010), manual muscle testing (MMT), Modified Ashworth Scale (MAS) (Figueiredo, 2011) and the 9-hole peg test (9HPT)(Figueiredo, 2011). The investigators also hypothesize that patients in the BURT cohort will report greater value/usefulness and interest/enjoyment.
- Conditions
- Stroke, Stroke, Acute, Cerebral Vascular Accident, Cerebral Vascular Accident (CVA)/Stroke
- Being tested
- BURT, Other Occupational Therapy
- Keywords
- BURT, Upper extremity function, Inpatient rehabilitation, Upper extremity robotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BURTDevice
Use of Barrett Upper extremity Robot (BURT) to improve strength and mobility of hemiplegic upper extremity.
Other Occupational TherapyProcedure or surgery
Standard occupational therapy sessions will be 60-90 minutes a day and are UE neuroeducation sessions are typically focused on improving strength and mobility of the hemipelagic arm.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Upper Extremity Neuroeducation | Active comparator | 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 Receives: Procedure: Other Occupational Therapy |
| BURT Upper Extremity | Experimental | 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. Receives: Device: BURT; Procedure: Other Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
UE Motor Assessment Scale (UE-MAS)
Used to assess motor functions in the affected upper extremity following a stroke. This evaluation uses task-oriented techniques instead of isolated movement patterns.
Measured: T2(Day 20-23) - T0 (Day 4-6)
UE Motor Assessment Scale (UE-MAS)
Used to assess motor functions in the affected upper extremity following a stroke. This evaluation uses task-oriented techniques instead of isolated movement patterns.
Measured: T1 (Day 12-14) - T0 (Day 4-6)
Manual Muscle Testing (MMT)
Used to assess the strength in a persons upper extremity based on various planes of movement. This is the most commonly used strength assessment.
Measured: T2(Day 20-23) - T0 (Day 4-6)
Manual Muscle Testing (MMT)
Used to assess the strength in a persons upper extremity based on various planes of movement. This is the most commonly used strength assessment.
Measured: T1 (Day 12-14) - T0 (Day 4-6)
Modified Ashworth Scale (MAS)
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
Measured: T2(Day 20-23) - T0 (Day 4-6)
Modified Ashworth Scale (MAS)
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
Measured: T1 (Day 12-14) - T0 (Day 4-6)
9 Hole Peg Test (9HPT)
The 9HPT is a standardized test that measures manual dexterity.
Measured: T2(Day 20-23) - T0 (Day 4-6)
9 Hole Peg Test (9HPT)
The 9HPT is a standardized test that measures manual dexterity.
Measured: T1 (Day 12-14) - T0 (Day 4-6)
Secondary outcomes (2)
GG Scores for Self-Care Items
standardized assessments of functional independence for feeding, bathing, toileting, footwear, upper and lower body dressing and oral hygiene.
Measured: Change from admission to discharge, up to 55 days
GG Scores for Mobility items
standardized assessments of functional independence for bed mobility and transfers.
Measured: Change from admission to discharge, up to 55 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Sep 2022
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnyview Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gaylord Hospital
- Responsible party
- Principal investigator, Casey Cowan, Sunnyview Rehabilitation Hospital
- Investigators
- Casey Cowan, MS OTR/L, Principal investigator, Sunnyview Rehabilitation HospitalEmily Steenburgh, MS OTR/L, Principal investigator, Sunnyview Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401799
- Sponsor's protocol ID
- 22-0324-1
- Status last verified
- May 2025
- First submitted
- 10 May 2022
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/
Zelter L. 2010. Motor Assessment Scale (MAS). https://strokengine.ca/en/assessments/motor-assessment-scale-mas/#:~:text=The%20Motor%20Assessment%20Scale%20(MAS,leakage%20from%20a%20blood%20vessel.
Figueiredo S ZL. 2011. Modified Ashworth Scale. https://strokengine.ca/en/assessments/modified-ashworth-scale/
Figueiredo S. 2011. Nine Hole Peg Test (NHPT). https://strokengine.ca/en/assessments/nine-hole-peg-test-nhpt/
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Barrett Upper Extremity Robot (BURT) for Improving Upper Extremity Strength and Function During Inpatient Rehabilitation Following Stroke.
- ClinicalTrials.gov ID
- NCT05401799
- Acronym / sponsor ID
- 22-0324-1
- Conditions
- Stroke, Stroke, Acute, Cerebral Vascular Accident, Cerebral Vascular Accident (CVA)/Stroke
- Keywords
- BURT, Upper extremity function, Inpatient rehabilitation, Upper extremity robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Sunnyview Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Gaylord Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Barrett Upper Extremity Robot (BURT) is an FDA-approved upper extremity robot that assists patients with both passive and active range of motion while providing adjustable resistance (Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/). Activities are directed by therapists and encourage patient involvement through video game activities providing active proprioceptive, vibrational, visual and auditory feedback. Engaging and colorful games are beneficial in holding patients' interest, and gravity assistance may also allow for increased repetition in the face of patient fatigue.
In this prospective study, the investigators will determine if a standardized BURT Upper Extremity (UE) program can be consistently implemented within an acute inpatient rehabilitation facility (IRF). In addition, the investigators will see if patients who receive BURT have improved UE mobility and function as a result. The investigators will also study the perceived enjoyment and value of the intervention by patients, and perceived value by therapists.
Because BURT therapy is able to provide more repetitions of upper extremity movement in a shorter length of time than conventional therapy, the investigators hypothesize that patients who participate in neuro re-education activities using BURT will achieve greater improvements in strength, upper extremity function, fine motor coordination, activities of daily living and mobility during their time in an IRF than patients receiving conventional therapy.
In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or BURT therapy. Meaningful clinical benchmarks for upper extremity function, tone, fine motor coordination, activities of daily living and mobility will be assessed using the Upper Extremity Motor Assessment Scale (UE-MAS)(Zelter, 2010), manual muscle testing (MMT), Modified Ashworth Scale (MAS) (Figueiredo, 2011) and the 9-hole peg test (9HPT)(Figueiredo, 2011). The investigators also hypothesize that patients in the BURT cohort will report greater value/usefulness and interest/enjoyment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Upper Extremity Neuroeducation | Active comparator | Procedure: Other Occupational Therapy74 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 Upper Extremity | Experimental | Device: BURT, Procedure: Other Occupational TherapyAs 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. |
Who may qualify
- Ages
- 18 to 115 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inpatient at Sunnyview Rehabilitation Hospital
- >/= 18 years
- Unilateral stroke
- UE paresis affected arm with 3-/5 or less manual muscle testing throughout
Key exclusion criteria (12 listed)
- >30 days post stroke
- Severe Neglect
- Bilateral stroke
- Prior stroke with residual deficits
- Patients receiving prism adaptation treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BURTUse of Barrett Upper extremity Robot (BURT) to improve strength and mobility of hemiplegic upper extremity. | Device | BURT Upper Extremity |
| Other Occupational TherapyStandard occupational therapy sessions will be 60-90 minutes a day and are UE neuroeducation sessions are typically focused on improving strength and mobility of the hemipelagic arm. | Procedure or surgery | BURT Upper Extremity, Conventional Upper Extremity Neuroeducation |
Primary outcome
UE Motor Assessment Scale (UE-MAS)
Time frame: T2(Day 20-23) - T0 (Day 4-6)
Used to assess motor functions in the affected upper extremity following a stroke. This evaluation uses task-oriented techniques instead of isolated movement patterns.
UE Motor Assessment Scale (UE-MAS)
Time frame: T1 (Day 12-14) - T0 (Day 4-6)
Used to assess motor functions in the affected upper extremity following a stroke. This evaluation uses task-oriented techniques instead of isolated movement patterns.
Manual Muscle Testing (MMT)
Time frame: T2(Day 20-23) - T0 (Day 4-6)
Used to assess the strength in a persons upper extremity based on various planes of movement. This is the most commonly used strength assessment.
Manual Muscle Testing (MMT)
Time frame: T1 (Day 12-14) - T0 (Day 4-6)
Used to assess the strength in a persons upper extremity based on various planes of movement. This is the most commonly used strength assessment.
Modified Ashworth Scale (MAS)
Time frame: T2(Day 20-23) - T0 (Day 4-6)
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
Modified Ashworth Scale (MAS)
Time frame: T1 (Day 12-14) - T0 (Day 4-6)
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
9 Hole Peg Test (9HPT)
Time frame: T2(Day 20-23) - T0 (Day 4-6)
The 9HPT is a standardized test that measures manual dexterity.
9 Hole Peg Test (9HPT)
Time frame: T1 (Day 12-14) - T0 (Day 4-6)
The 9HPT is a standardized test that measures manual dexterity.
2 secondary outcomes
GG Scores for Self-Care Items
Time frame: Change from admission to discharge, up to 55 days
GG Scores for Mobility items
Time frame: Change from admission to discharge, up to 55 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- BackgroundBarrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/
- BackgroundZelter L. 2010. Motor Assessment Scale (MAS). https://strokengine.ca/en/assessments/motor-assessment-scale-mas/#:~:text=The%20Motor%20Assessment%20Scale%20(MAS,leakage%20from%20a%20blood%20vessel.
- BackgroundFigueiredo S ZL. 2011. Modified Ashworth Scale. https://strokengine.ca/en/assessments/modified-ashworth-scale/
- BackgroundFigueiredo S. 2011. Nine Hole Peg Test (NHPT). https://strokengine.ca/en/assessments/nine-hole-peg-test-nhpt/
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Casey Cowan, MS OTR/L principal investigator
Sunnyview Rehabilitation Hospital
Emily Steenburgh, MS OTR/L principal investigator
Sunnyview Rehabilitation Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BURT and Other Occupational Therapy in people with Stroke and Stroke, Acute, run by Sunnyview Rehabilitation Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UE Motor Assessment Scale (UE-MAS) (time frame: T2(Day 20-23) - T0 (Day 4-6)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05401799, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.