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Electrical Muscle Stimulation for Stroke Balance and Fall Risk (NMES Trial)

N/A

Recruiting

Led By Tanvi Bhatt, PhD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

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

Must have

Age group: 18-90 years

Ability to walk independently with or without an assistive device for at least 300 ft

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (1st novel slip/trip, session 2, week 1)

Awards & highlights

NMES Trial Summary

This trial is investigating whether electrical stimulation of different muscles can help improve balance and walking in people who have had a stroke.

Who is the study for?

This trial is for adults aged 18-90 who've had a stroke at least 6 months ago, can walk independently (with or without help) for at least 300 ft, and have no major health issues like heart disease or uncontrolled high blood pressure. They should be able to understand English and follow the study's instructions.Check my eligibility

What is being tested?

The study tests if neuromuscular electrical stimulation (NMES), specifically functional electrical stimulation (FES) on lower limb muscles, can improve balance and walking after a stroke. Participants will try walking with FES in different settings while their movement is monitored.See study design

What are the potential side effects?

Possible side effects of NMES/FES may include discomfort or skin irritation where the electrodes are placed, muscle fatigue from the stimulated contractions, and in rare cases, it could lead to falls during balance tasks.

NMES Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 90 years old.

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I can walk on my own for at least 300 feet, with or without help like a cane.

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I am mentally able to follow the treatment plan.

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I have weakness on one side of my body.

NMES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (1st novel slip/trip, session 2, week 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (1st novel slip/trip, session 2, week 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (1st novel slip/trip, session 2, week 1) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Laboratory Falls

Secondary outcome measures

Center of mass excursion angle

Compensatory step execution time

Compensatory step initiation time

+8 more

NMES Trial Design

1Treatment groups

Experimental Treatment

Group I: Effect of functional electrical stimulation on reactive balance and laboratory fallsExperimental Treatment1 Intervention

All individuals will be assigned to the experimental group and will undergo the testing and training procedure across two separate sessions. During the first session, the participants will go through the complete initial screening process. If eligible for the study, the participants will perform the experimental training protocols during the second session. Experimental Protocol The quadriceps, hamstrings, tibialis anterior, gastrocnemius, and the trunk muscle group on the stroke-affected side (weaker side) will be stimulated according to the participant's comfort and tolerance. The range of the intensity allowed by the device is 0-50milliamperes (mA). The frequency of the electrical stimulation device ranges from 1-60Hz.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor

608 Previous Clinical Trials

1,559,229 Total Patients Enrolled

18 Trials studying Stroke

2,231 Patients Enrolled for Stroke

Tanvi Bhatt, PhDPrincipal InvestigatorUniversity of Illinois at Chicago

5 Previous Clinical Trials

568 Total Patients Enrolled

2 Trials studying Stroke

120 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.

Am I eligible to partake in this medical experiment?

"For this trial, 20 eligible individuals aged 18-90 that have had stroke for more than 6 months are needed. Additionally, each participant must be able to walk at least 300 feet independently or with an aid and display signs of hemiparesis."

Answered by AI

Does the study include any participants who are younger than 45 years old?

"This clinical trial has established that the youngest participant should be 18 years of age and elderly patients up to 90 may take part."

Answered by AI

Are there still opportunities for people to be involved in this research endeavor?

"Clinicaltrials.gov shows that this trial, originating from May 15th 2021 and updated on July 8th 2021 is no longer enrolling patients. Despite this, there are many other medical studies currently recruiting participants, a total of 1046 as of now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of NMES on Balance and Fall Risk in Chronic Stroke

Tanvi Bhatt 2021. "Effect of NMES on Balance and Fall Risk in Chronic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04957355.