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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up across experimental sessions spanning a typical time frame of 4 to 6 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can slightly bend my wrist upwards.
Select...
I have mild-to-moderate difficulty moving my arms.
Select...
I have trouble sensing joint movement in my elbow on the side of my body opposite to my stronger arm.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Root Mean Square Kinematic Error
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
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,700 Total Patients Enrolled
Marquette UniversityLead Sponsor
62 Previous Clinical Trials
200,293 Total Patients Enrolled
Medical College of WisconsinOTHER
609 Previous Clinical Trials
1,162,553 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of other mental health conditions like schizophrenia.I am not currently using drugs that affect muscle function.I had a stroke but can still stabilize and grip objects.I can feel touch in my arm or thigh on the same side as my lesion.I can slightly bend my wrist upwards.I have a tumor inside my brain.My muscles in the testing area are very weak or have shrunk significantly.I have a systemic infection.You have had seizures in the past.I had a stroke in the middle cerebral artery over 6 months ago.I can understand and follow detailed instructions.I have a heart pacemaker, irregular heartbeat, or serious heart/lung issues.I have mild-to-moderate difficulty moving my arms.I have a bleeding disorder.I do not have conditions like myasthenia gravis or ALS that affect muscle control.I have stiff joints or have had tendon surgery in my affected limb.I have a health condition that may prevent me from following the study's requirements.I have trouble sensing joint movement in my elbow on the side of my body opposite to my stronger arm.
Research Study Groups:
This trial has the following groups:- Group 1: Stroke Cohort - Progressive Training
- Group 2: Stroke Cohort - Whole Task Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for participants in this experiment?
"Affirmative. Per the information hosted on clinicaltrials.gov, this investigation is actively seeking participants and was first posted in October of 2017, with its last edit occuring on May 8th 2023. 58 patients from a single site are needed for the trial to be successful."
Answered by AI
To what extent is this medical trial being utilized by patients?
"Affirmative. The clinical trial is currently recruiting participants, and according to the information hosted on clinicaltrials.gov, this study was first posted on October 30th 2017 and last updated on May 8th 2023. There are 58 patients that need to be recruited from a single medical centre."
Answered by AI
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