Sensory Feedback for Stroke

Overseen By Sang Wook Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: The Catholic University of America

Disqualifiers: Severe illness, Pain, Loss of control, Musculoskeletal injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Periprocedural

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The following experiment will be conducted with 15 chronic stroke survivors and 15 control subjects. Subjects will perform hand movements in the virtual reality environment using a head-mounted display. Quest's onboard cameras allow real-time tracking of hand motion, estimating joint angles of the finger and the thumb. For each feedback manipulation condition (i.e., movement amplification or reduction), the estimated joint angles will be multiplied by a factor greater than 1 (amplification) or a factor smaller than 1 (reduction). Then the newly-estimated hand posture will be displayed in the VR environment. Subjects will be randomly assigned into two groups (A and B), who will receive the assistance in a different order. Subjects will perform finger extension under three conditions: no sensory modulation, movement visual feedback (VF) amplification, and movement VF reduction (error augmentation), while their movement muscle activation patterns are recorded.

Are You a Good Fit for This Trial?

This trial is for adults aged 20-70 who had their first stroke affecting one side of the brain at least 6 months ago and have moderate arm weakness. People with other major health issues or recent strokes cannot join.

Inclusion Criteria

I am between 20 and 70 years old.

My arm function score is between 31 and 55 on the Fugl-Meyer scale.

I had my first stroke on one side of my brain over 6 months ago, causing weakness on one side.

Exclusion Criteria

Presence of concurrent severe medical illness

I cannot voluntarily move my fingers or thumb.

I have a serious injury or medical complication like a fracture or heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform hand movements in a virtual reality environment under different sensory feedback conditions

Periprocedural

Multiple sessions in VR environment

Follow-up

Participants are monitored for changes in muscle activation and joint range of motion

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Visual ROM augmentation
• Visual ROM reduction

Trial Overview

The study tests how changing visual feedback in virtual reality affects hand movement after a stroke. Participants will see either amplified or reduced finger movements while wearing a VR headset, to see if this helps improve motor control.

How Is the Trial Designed?

Group I: Visual ROM reduction followed by visual ROM augmentation Experimental Treatment 2 Interventions

Group II: Visual ROM augmentation followed by visual ROM reduction Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

The Catholic University of America

Lead Sponsor

Trials

15

Recruited

2,700+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+