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Neuromuscular Electrical Stimulation

NMES Strength Training for Cerebral Palsy

Phase 1

Waitlist Available

Led By Samuel CK Lee, PhD, PT

Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria Checklist

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

Must have

GMFCS level of II or III (able to walk indoors and outdoors with or without an assistive device)

PROM requirements (<10 degree hip flexion contracture, >20 degrees of hip abduction, < 5 degrees of knee flexion contracture, > 45 degree popliteal angle, ankle dorsiflexion to neutral with knee extension)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre, mid, post, washout

Awards & highlights

Study Summary

This trial will compare the effects of NMES vs. volitional exercise in children with cerebral palsy.

Who is the study for?

This trial is for children aged 7-12 with spastic diplegic cerebral palsy, who can walk with or without help and have basic cognitive skills to follow instructions. They should not have severe orthopedic issues, recent surgeries (within a year), botulinum toxin injections within the last 6 months, or uncontrolled seizures.Check my eligibility

What is being tested?

The study is testing if high-intensity neuromuscular electrical stimulation (NMES) is more effective than regular exercise at improving muscle strength and motor function in kids with cerebral palsy.See study design

What are the potential side effects?

Possible side effects of NMES may include discomfort during stimulation, skin irritation under electrode pads, muscle fatigue after training sessions, and rarely muscle soreness.

Eligibility Criteria

Inclusion Criteria

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

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I can walk indoors and outdoors, with or without help.

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My hip and knee movements meet the specific range needed.

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I can understand instructions and communicate well enough to participate in the study.

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I have been diagnosed with spastic diplegic cerebral palsy.

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I am between 7 and 12 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre, mid, post, washout

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre, mid, post, washout

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre, mid, post, washout for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Antagonist coactivation during an agonist MVIC

Contractile properties as assessed via electrically-elicited tests

Fatiguability of muscle as assessed via electrically-elicited tests

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: NMES Strengthening GroupExperimental Treatment1 Intervention

Subjects will complete 12 weeks of NMES isometric strength training using implanted electrodes in bilateral quadriceps and triceps surae muscles.

Group II: Control GroupActive Control1 Intervention

No Intervention Control Group

Group III: Volitional StrengtheningActive Control1 Intervention

Subjects will complete 12 weeks of volitional isometric strength training of bilateral quadriceps and triceps surae muscles.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of DelawareOTHER

154 Previous Clinical Trials

25,166 Total Patients Enrolled

5 Trials studying Cerebral Palsy

253 Patients Enrolled for Cerebral Palsy

Shriners Hospitals for ChildrenOTHER

97 Previous Clinical Trials

23,919 Total Patients Enrolled

12 Trials studying Cerebral Palsy

648 Patients Enrolled for Cerebral Palsy

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor

1,964 Previous Clinical Trials

2,674,685 Total Patients Enrolled

29 Trials studying Cerebral Palsy

8,713 Patients Enrolled for Cerebral Palsy

Media Library

NMES Strength Training (Neuromuscular Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT00356343 — Phase 1

Cerebral Palsy Research Study Groups: Control Group, NMES Strengthening Group, Volitional Strengthening

Cerebral Palsy Clinical Trial 2023: NMES Strength Training Highlights & Side Effects. Trial Name: NCT00356343 — Phase 1

NMES Strength Training (Neuromuscular Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00356343 — Phase 1

Frequently Asked Questions

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

Is this research endeavor currently accepting participants?

"The clinical trial's last update on the 1st of September 2011 has made it clear that recruitment is no longer occurring. Nonetheless, 249 additional studies are currently enrolling participants."

Answered by AI

Can adolescents aged twenty-five and under partake in this clinical exploration?

"The age range stipulated by this medical trial's eligibility criteria is 7-12 years old."

Answered by AI

What criteria must be fulfilled to enroll in this research endeavor?

"This clinical trial is accepting 45 children aged between 7 and 12 years-old, who are diagnosed with diplegic spastic cerebral palsy. Furthermore, they must demonstrate a Gross Motor Function Classification System level of either II or III (allowing them to independently walk inside and outside), possess less than 10 degrees of hip flexion contracture and more than 20 degrees of hip abduction, be able to achieve ankle dorsiflexion whilst in the knee extension position as well as displaying no greater than 5 degrees of knee flexion contracture, form an angle exceeding 45 when measured at the popliteal area, plus have sufficient cognitive/communication"

Answered by AI

Has the FDA sanctioned NMES Strength Training?

"Due to the lack of clinical data available, NMES Strength Training was given a score of 1 on our safety scale. This is because it is currently in Phase 1 trials with limited evidence supporting its efficacy and security."

Answered by AI

Recent research and studies

Muscle & NerveJournal

Voluntary Muscle Activation, Contractile Properties, and Fatigability in Children with and Without Cerebral Palsy

Stackhouse, Scott K., Stuart A. Binder-Macleod, and Samuel C. K. Lee. 2005. “Voluntary Muscle Activation, Contractile Properties, and Fatigability in Children with and Without Cerebral Palsy”. Muscle & Nerve. Wiley. doi:10.1002/mus.20302.

clinicaltrials.govStudy

Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy

2004. "Strength Training Using Neuromuscular Electrical Stimulation For Children With Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00356343.

All > Cerebral Palsy