Feedback Training for Hand Function After Stroke

(NEAD Trial)

Overseen by Na Jin Seo, PhD MS BS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

Despite the functional importance, fingertip forces are rarely explicitly addressed with feedback in therapy. This gap in treatment is due to a lack of tools to provide explicit feedback on patients' volitional finger force generation. To address this unmet need, the investigators developed a novel tool for practice of volitional three-dimensional (3D) force generation with explicit feedback. The objective of this project is to determine if 3D finger force training is an effective tool in restoring hand function post stroke.

Research Team

Na Jin Seo, PhD MS BS

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Eligibility Criteria

This trial is for stroke survivors with moderate to severe hand impairment who can grip and follow simple instructions. They should be at least 3 months post-stroke, have some cognitive ability, and no visual field loss. Excluded are those in other upper limb rehab, with severe muscle tone issues or total sensory loss in fingertips, recent spasticity treatment changes, or certain comorbidities.

Inclusion Criteria

You had a stroke at least 3 months ago.

You can squeeze an object when asked to do so.

You need to be able to understand and follow simple instructions.

Exclusion Criteria

You are currently undergoing therapy for your upper limbs.

You have difficulty understanding and following simple instructions.

You have very tight muscles that make it hard for you to move your fingers or place them correctly for the training.

Treatment Details

Interventions

• 1D (Behavioural Intervention)
• 3D (Behavioural Intervention)

Trial Overview The study tests a new tool that gives feedback on finger force direction during exercises (1D vs. 3D training) to see if it helps restore hand function after a stroke. Participants will use this tool to practice generating forces with their fingers in different directions.

Participant Groups

Group I: 3D Experimental Treatment 1 Intervention

The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.

Group II: 1D Active Control 1 Intervention

The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine