BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04940403
• Other study ID #: 2021P001807
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: August 2022
• Source: Spaulding Rehabilitation Hospital
• Contact: Catherine Adans-Dester, PhD
• Phone: 617-952-6321
• Email: CADANS-DESTER[@]PARTNERS.ORG
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: June 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or female, 18-80 years old;

2. Unilateral ischemic or hemorrhagic stroke at least 6 months and no more than 5 years prior to study enrollment;

3. Upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 12 and 40;

4. Some active pro-supination range of motion;

5. Some active metacarpal-phalangeal joint in the hemiparetic hand;

6. Intact cognitive function to understand the robotic therapy procedures (MMSE>23 and able to follow 3 step command) during initial evaluation visit;

Exclusion Criteria:

1. Undergoing upper-limb rehabilitation therapy during the period of the study.

2. Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe use of the robotic system;

3. 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);

4. Severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening;

5. Communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record);

6. Individuals with open wounds or recent fracture (<3 months) in the upper extremity, fragile skin or active infection;

7. Upper-extremity orthopedic injuries or severe pain resulting in movement limitations.

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Activity Log- Amount of Use	Self-reported measures of upper extremity activity performance in daily life (amount of use)	Data will be collected at baseline and at 7-8 weeks
Secondary	Fugl-Meyer Assessment, Upper-Extremity portion	Assessment of the severity of upper-limb motor impairments	Data will be collected at baseline and at 7-8 weeks
Secondary	Wolf Motor Function Test	Assessment of arm functional limitations	Data will be collected at baseline and at 7-8 weeks
Secondary	Stroke Impact Scale	Self-reported measure of quality of life after stroke	Data will be collected at baseline and at 7-8 weeks
Secondary	Motor Activity Log- Quality of Use	Self-reported measures of upper extremity activity performance in daily life (quality of use)	Data will be collected at baseline and at 7-8 weeks
Secondary	Upper-Extremity Accelerometry	Amount of arm use over 72 hours recording with wrist-worn sensors	Data will be collected at baseline and at 7-8 weeks