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Not yet recruiting NCT04940403

BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Burt, Burt + BurtVision.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Motor Activity Log- Amount of Use [Time frame: Data will be collected at baseline and at 7-8 weeks]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04940403 · 2021P001807

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗