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Behavioural Intervention

Vibrotactile Stimulation for Stroke

Phase 1

Recruiting

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).

Awards & highlights

Study Summary

This trial aims to study the use of wearable devices that provide vibration feedback on the arms of stroke patients. It wants to find out if patients can tolerate wearing these devices and if the vibration helps improve arm

Who is the study for?

This trial is for stroke patients who are currently inpatients at rehabilitation units, had a stroke on one side of the body within the last 2 weeks, and have some arm movement. They should be able to stay for 2-3 weeks in rehab and participate in additional therapy with special gloves and shirts that provide gentle vibrations.Check my eligibility

What is being tested?

The study is testing if wearing gloves and shirts that give off gentle vibrations (vibrotactile stimulation) can help improve arm function after a stroke. Patients will use these wearables for five hours daily along with their regular therapy, while their progress is compared to those receiving only conventional therapy.See study design

What are the potential side effects?

Potential side effects may include discomfort or skin irritation from the wearable devices. Since this treatment involves non-invasive stimulation, serious side effects are not expected but participants' tolerance to the wearables will be closely monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)

Secondary outcome measures

Change in the modified Ashworth scale

Number of participants who completed the therapy

Number of participants who tolerated the vibrotactile stimulation therapy

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vibrotactile StimulationExperimental Treatment1 Intervention

Participants wear vibrotactile stimulation shirts and gloves for 5 hours per day, 7 days per week, during their stay at the rehabilitation unit, which is expected to be between 2-3 weeks. Participants wear the devices after conventional therapy is done for the day.

Group II: ControlActive Control1 Intervention

Participants undergo conventional therapy only.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vibrotactile Stimulation

2016

N/A

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,739 Previous Clinical Trials

2,150,121 Total Patients Enrolled

6 Trials studying Stroke

12,230 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than 18 years being sought for participation in this research project?

"The trial is seeking individuals over the age of 50 but under 70 to participate."

Answered by AI

Has Vibrotactile Stimulation received approval from the FDA?

"The safety rating assigned to Vibrotactile Stimulation by our team at Power is 1, reflecting the early Phase 1 trial stage with minimal available data on both safety and efficacy."

Answered by AI

What are the eligibility criteria for individuals interested in participating in this research project?

"This clinical study is enrolling 24 individuals aged between 50 and 70 who have recently experienced a unilateral ischemic stroke. The key criteria include being inpatients at rehabilitation units, having Upper-Extremity Fugl-Meyer scores ranging from 6 to 58, showing a minimum of 20 degrees of active shoulder elevation and elbow flexion, with an expected stay duration of 2 to 3 weeks in the rehabilitation unit following the stroke occurrence within the past two weeks."

Answered by AI

What is the current number of individuals participating in this clinical study?

"Indeed, as per the details on clinicaltrials.gov, this medical investigation is currently seeking eligible individuals. The trial was initially listed on February 2nd, 2024 and most recently revised on April 9th of the same year. A total of 24 participants are being sought across two designated sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation

2024. "Vibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06244719.

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