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Vibrotactile Stimulation for Stroke Recovery

N/A

Recruiting

Led By Leigh A Mrotek, PhD

Research Sponsored by Marquette University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A minimal active wrist extension of 5°

Mild-to-moderate motor impairment as assessed using the upper extremity (UE) portion of the Fugl-Meyer Motor Assessment (FM); i.e., UE-FM score between 28 and 50 (inclusive) out of a possible 66

Must not have

Subjects who are currently using or under the influence of aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function

Malignant or benign intra-axial neoplasms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up across experimental sessions spanning a typical time frame of 4 to 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether adding vibrotactile stimulation can help improve arm function for people who have lost proprioception after a stroke.

Who is the study for?

This trial is for stroke survivors with mild-to-moderate arm impairment, who can feel touch in the affected arm or thigh and have a minimal ability to extend their wrist. They must be at least 6 months post-stroke from an MCA event, able to consent and follow instructions, and have specific proprioceptive deficits. People with bleeding disorders, muscle diseases like ALS or myasthenia gravis, epilepsy, severe psychiatric conditions, pacemakers or significant heart issues cannot join.

What is being tested?

The study tests if vibrotactile stimulation—a type of sensory feedback—can help improve arm function after stroke. Thirty participants will try this method while doing tasks like reaching out or simulating drinking from a glass to see if it enhances motor control.

What are the potential side effects?

While not explicitly stated in the provided information, typical side effects of vibrotactile stimulation may include skin irritation where the device is applied and potential discomfort due to vibration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can slightly bend my wrist upwards.

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I have mild-to-moderate difficulty moving my arms.

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I have trouble sensing joint movement in my elbow on the side of my body opposite to my stronger arm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently using drugs that affect muscle function.

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I have a tumor inside my brain.

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My muscles in the testing area are very weak or have shrunk significantly.

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I have a systemic infection.

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I can understand and follow detailed instructions.

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I have a heart pacemaker, irregular heartbeat, or serious heart/lung issues.

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I have a bleeding disorder.

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I do not have conditions like myasthenia gravis or ALS that affect muscle control.

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I have stiff joints or have had tendon surgery in my affected limb.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ across experimental sessions spanning a typical time frame of 4 to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~across experimental sessions spanning a typical time frame of 4 to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and across experimental sessions spanning a typical time frame of 4 to 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

Root Mean Square Kinematic Error

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stroke Cohort - Whole Task TrainingExperimental Treatment1 Intervention

Aim2 intervention: Vibrotactile stimulation. Training on only the more complex reaching task using vibrotactile feedback to guide performance

Group II: Stroke Cohort - Progressive TrainingExperimental Treatment1 Intervention

Aim 1 intervention: Vibrotactile stimulation. Progressive training from simple to more complex reaching task using vibrotactile feedback to guide performance

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vibrotactile stimulation

2017

N/A

~170

0 / 12Eligibility criteria met