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Behavioural Intervention

Sensory Stimulation for Stroke Recovery

N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
WFMT hand task average time <120 s
18 years old or older
Must not have
Currently undergoing other upper limb therapy
Severe spasticity that limits participation in task practice therapy (e.g., Modified Ashworth Scale=4-5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 weeks

Summary

This trial will test if adding vibration to hand task practice can help people with movement disabilities.

Who is the study for?
This trial is for adults over 18 who had a stroke at least 6 months ago and have difficulty with hand tasks. They must be able to follow instructions and not be on certain spasticity medications or undergoing other upper limb therapies. Severe spasticity, skin issues at the wrist, or other conditions affecting arm function disqualify them.
What is being tested?
The study is testing if adding vibration to regular hand exercises helps improve hand function better than just doing the exercises alone after a stroke. Participants will either receive real vibration stimulation or no stimulation while practicing hand tasks.
What are the potential side effects?
Since this trial involves non-invasive sensory stimulation and physical therapy, side effects are minimal but may include temporary discomfort or skin irritation from the vibration device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can complete hand tasks quickly, in less than 120 seconds.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving therapy for my arm.
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My severe muscle stiffness hinders my ability to participate in physical therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Score of Wolf Motor Function Test (WMFT)
Secondary study objectives
Change in Score of Action Research Arm Test
Change in Score of Box and Blocks Test

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: VibrationActive Control1 Intervention
The device will deliver imperceptible vibration for the treatment group.
Group II: No VibrationPlacebo Group1 Intervention
The device will deliver no vibration for the control group.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
973 Previous Clinical Trials
7,399,308 Total Patients Enrolled
73 Trials studying Stroke
62,220 Patients Enrolled for Stroke
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,810 Total Patients Enrolled
84 Trials studying Stroke
5,723 Patients Enrolled for Stroke

Media Library

Concomitant Sensory Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04569123 — N/A
Stroke Research Study Groups: Vibration, No Vibration
Stroke Clinical Trial 2023: Concomitant Sensory Stimulation Highlights & Side Effects. Trial Name: NCT04569123 — N/A
Concomitant Sensory Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04569123 — N/A
~14 spots leftby Nov 2025
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