Your session is about to expire
← Back to Search
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
No Placebo-Only Group
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 belowSelect...
I can walk indoors and outdoors, with or without help.
Select...
My hip and knee movements meet the specific range needed.
Select...
I can understand instructions and communicate well enough to participate in the study.
Select...
I have been diagnosed with spastic diplegic cerebral palsy.
Select...
I am between 7 and 12 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
25,507 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
2,061 Previous Clinical Trials
2,745,103 Total Patients Enrolled
33 Trials studying Cerebral Palsy
8,867 Patients Enrolled for Cerebral Palsy
Samuel CK Lee, PhD, PTPrincipal InvestigatorUniversity of Delaware, Shriners Hospitals for Children
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It has been over 6 months since my last botulinum toxin injection.I can walk indoors and outdoors, with or without help.My hip and knee movements meet the specific range needed.I can understand instructions and communicate well enough to participate in the study.It has been over a year since my orthopedic surgery.I have been diagnosed with spastic diplegic cerebral palsy.I have seizures that are not controlled by medication.I have major issues with my bones, like severe hip or spine problems.I am between 7 and 12 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: NMES Strengthening Group
- Group 3: Volitional Strengthening
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.