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NCT Number: NCT04940403

BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

BURT

Device

18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt.

Burt + BurtVision

Device

18 one-hour sessions of combination of unimanual and bimanual upper-limb tasks during robot-assisted training with the BurtVision.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Fugl-Meyer Assessment, Upper-Extremity portion

    Time frame: Data will be collected at baseline and at 7-8 weeks

    Assessment of the severity of upper-limb motor impairments

  2. Wolf Motor Function Test

    Time frame: Data will be collected at baseline and at 7-8 weeks

    Assessment of arm functional limitations

  3. Stroke Impact Scale

    Time frame: Data will be collected at baseline and at 7-8 weeks

    Self-reported measure of quality of life after stroke

  4. Motor Activity Log- Quality 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 (quality of use)

  5. Upper-Extremity Accelerometry

    Time frame: Data will be collected at baseline and at 7-8 weeks

    Amount of arm use over 72 hours recording with wrist-worn sensors

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Adans-Dester, PhD

CONTACT

[email protected]

617-952-6321

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors: a Comparison of Unimanual vs. Unimanual and Bimanual Tasks During Robot-assisted Arm Training

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2021
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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