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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)
Must not have
Must be at least one year post orthopedic surgery
Uncontrolled seizure activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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It has been over a year since my orthopedic surgery.
Select...
I have seizures that are not controlled by medication.
Select...
I have major issues with my bones, like severe hip or spine problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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.

Find a Location

Who is running the clinical trial?

University of DelawareOTHER
161 Previous Clinical Trials
25,651 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
2,014 Previous Clinical Trials
2,696,789 Total Patients Enrolled
31 Trials studying Cerebral Palsy
8,740 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
~2 spots leftby Sep 2025
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