StrokeNCT04940403
BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:
A study testing Burt and Burt + BurtVision in people with Stroke, run by Spaulding Rehabilitation Hospital.
Trial summary
The focus of this study is to perform a preliminary assessment of the efficacy of the BurtVision system. While the Burt robotic-arm assists the patient's upper-limb in their movements, BurtVision will allow the patient to perform unimanual and bimanual activities while leveraging augmented reality games. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Burt and Burt + BurtVision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-80 years old;
- Unilateral ischemic or hemorrhagic stroke at least 6 months and no more than 5 years prior to study enrollment;
- Upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 12 and 40;
- Some active pro-supination range of motion;
- Some active metacarpal-phalangeal joint in the hemiparetic hand;
- Intact cognitive function to understand the robotic therapy procedures (MMSE>23 and able to follow 3 step command) during initial evaluation visit;
Who cannot join
- Undergoing upper-limb rehabilitation therapy during the period of the study.
- Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe use of the robotic system;
- Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject's ability to play the interactive games (as assessed with the line bisection test);
- Severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening;
- Communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record);
- Individuals with open wounds or recent fracture (<3 months) in the upper extremity, fragile skin or active infection;
- Upper-extremity orthopedic injuries or severe pain resulting in movement limitations.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors: a Comparison of Unimanual vs. Unimanual and Bimanual Tasks During Robot-assisted Arm Training
The focus of this study is to perform a preliminary assessment of the efficacy of the BurtVision system. While the Burt robotic-arm assists the patient's upper-limb in their movements, BurtVision will allow the patient to perform unimanual and bimanual activities while leveraging augmented reality games. The investigators will compare clinical outcomes when the BurtVisions ystem is used for training solely relying on unimanual tasks vs. when it is used for training relying on both unimanual and bimanual tasks.
Read the detailed description
The proposed study is a single-blinded randomized clinical trial to evaluate the effect of using the BurtVistion on motor gains after robot-assisted upper-limb. Study participants (stroke survivors) will be recruited at the Spaulding Rehabilitation Hospital - Boston. Subjects will be randomly assigned to one of the two different groups: unimanual or unimanual + bimanual arm therapy using a block-randomized allocation procedure to ensure important covariates, such as baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores and chronicity, are balanced between groups.
- Conditions
- Stroke
- Being tested
- Burt, Burt + BurtVision
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BurtDevice
18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt.
Burt + BurtVisionDevice
18 one-hour sessions of combination of unimanual and bimanual upper-limb tasks during robot-assisted training with the BurtVision.
| Study group | Role | What they receive |
|---|---|---|
| Unimanual robot-assisted upper-limb rehabilitation | Active comparator | Participants randomized to this arm of the study will undergo 18 one-hour sessions of robot-assisted upper-limb rehabilitation. During the sessions, study participants will only train their hemiparetic arm (unimanual tasks only). Receives: Device: Burt |
| Bimanual robot-assisted upper-limb rehabilitation | Experimental | Participants randomized to this arm of the study will undergo 18 one-hour sessions of robot-assisted upper-limb rehabilitation. During the sessions, study participants will train their hemiparetic arm as well as interacting with the contralateral arm for bimanual tasks (unimanual + bimanual tasks). Receives: Device: Burt + BurtVision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Activity Log- Amount of Use
Self-reported measures of upper extremity activity performance in daily life (amount of use)
Measured: Data will be collected at baseline and at 7-8 weeks
Secondary outcomes (5)
Fugl-Meyer Assessment, Upper-Extremity portion
Assessment of the severity of upper-limb motor impairments
Measured: Data will be collected at baseline and at 7-8 weeks
Wolf Motor Function Test
Assessment of arm functional limitations
Measured: Data will be collected at baseline and at 7-8 weeks
Stroke Impact Scale
Self-reported measure of quality of life after stroke
Measured: Data will be collected at baseline and at 7-8 weeks
Motor Activity Log- Quality of Use
Self-reported measures of upper extremity activity performance in daily life (quality of use)
Measured: Data will be collected at baseline and at 7-8 weeks
Upper-Extremity Accelerometry
Amount of arm use over 72 hours recording with wrist-worn sensors
Measured: Data will be collected at baseline and at 7-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Sep 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Study participants will be randomized to either 1) manual robot-assisted upper-limb rehabilitation, and 2) unimanual+bimanual robot-assisted upper-limb rehabilitation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Harvard Medical School, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940403
- Sponsor's protocol ID
- 2021P001807
- Status last verified
- Mar 2026
- First submitted
- 17 Jun 2021
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors: a Comparison of Unimanual vs. Unimanual and Bimanual Tasks During Robot-assisted Arm Training
- ClinicalTrials.gov ID
- NCT04940403
- Acronym / sponsor ID
- 2021P001807
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 25 Jun 2021 (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 focus of this study is to perform a preliminary assessment of the efficacy of the BurtVision system. While the Burt robotic-arm assists the patient's upper-limb in their movements, BurtVision will allow the patient to perform unimanual and bimanual activities while leveraging augmented reality games. The investigators will compare clinical outcomes when the BurtVisions ystem is used for training solely relying on unimanual tasks vs. when it is used for training relying on both unimanual and bimanual tasks.
Detailed description
The proposed study is a single-blinded randomized clinical trial to evaluate the effect of using the BurtVistion on motor gains after robot-assisted upper-limb. Study participants (stroke survivors) will be recruited at the Spaulding Rehabilitation Hospital - Boston. Subjects will be randomly assigned to one of the two different groups: unimanual or unimanual + bimanual arm therapy using a block-randomized allocation procedure to ensure important covariates, such as baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores and chronicity, are balanced between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study participants will be randomized to either 1) manual robot-assisted upper-limb rehabilitation, and 2) unimanual+bimanual robot-assisted upper-limb rehabilitation
| Arm | Type | Receives |
|---|---|---|
| Unimanual robot-assisted upper-limb rehabilitation | Active comparator | Device: BurtParticipants randomized to this arm of the study will undergo 18 one-hour sessions of robot-assisted upper-limb rehabilitation. During the sessions, study participants will only train their hemiparetic arm (unimanual tasks only). |
| Bimanual robot-assisted upper-limb rehabilitation | Experimental | Device: Burt + BurtVisionParticipants randomized to this arm of the study will undergo 18 one-hour sessions of robot-assisted upper-limb rehabilitation. During the sessions, study participants will train their hemiparetic arm as well as interacting with the contralateral arm for bimanual tasks (unimanual + bimanual tasks). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 18-80 years old;
- Unilateral ischemic or hemorrhagic stroke at least 6 months and no more than 5 years prior to study enrollment;
- Upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 12 and 40;
- Some active pro-supination range of motion;
- Some active metacarpal-phalangeal joint in the hemiparetic hand;
Key exclusion criteria (7 listed)
- Undergoing upper-limb rehabilitation therapy during the period of the study.
- Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe use of the robotic system;
- Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject's ability to play the interactive games (as assessed with the line bisection test);
- Severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening;
- Communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record);
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 |
|---|---|---|
| Burt18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt. | Device | Unimanual robot-assisted upper-limb rehabilitation |
| Burt + BurtVision18 one-hour sessions of combination of unimanual and bimanual upper-limb tasks during robot-assisted training with the BurtVision. | Device | Bimanual robot-assisted upper-limb rehabilitation |
Primary outcome
Motor Activity Log- Amount of Use
Time frame: Data will be collected at baseline and at 7-8 weeks
Self-reported measures of upper extremity activity performance in daily life (amount of use)
5 secondary outcomes
Fugl-Meyer Assessment, Upper-Extremity portion
Time frame: Data will be collected at baseline and at 7-8 weeks
Wolf Motor Function Test
Time frame: Data will be collected at baseline and at 7-8 weeks
Stroke Impact Scale
Time frame: Data will be collected at baseline and at 7-8 weeks
Motor Activity Log- Quality of Use
Time frame: Data will be collected at baseline and at 7-8 weeks
Upper-Extremity Accelerometry
Time frame: Data will be collected at baseline and at 7-8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Paolo Bonato, PhD principal investigator
Harvard Medical School, Spaulding Rehabilitation Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Burt and Burt + BurtVision in people with Stroke, run by Spaulding Rehabilitation Hospital.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Adans-Dester, PhD (617-952-6321, CADANS-DESTER@PARTNERS.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Activity Log- Amount of Use (time frame: Data will be collected at baseline and at 7-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.