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Electric Stimulation
Electric Stimulation for Cerebral Palsy
N/A
Recruiting
Led By Samuel Lee, PT, PhD
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 assessment points: baseline - pre stimulation cop, and at the end of the session with stimulation (day 1)- post stimulation cop
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether electrical stimulation can help people with CP maintain balance during tasks like standing up and walking, which may improve function and reduce falls.
Who is the study for?
This trial is for children and young adults aged 8-24 with Cerebral Palsy (CP), specifically those who can stand up from a chair and walk but have difficulty maintaining balance. They should not have other neurological or musculoskeletal disorders, be seizure-free or have well-controlled seizures, and possess sufficient cognitive skills to communicate discomfort.
What is being tested?
The study tests if light electrical stimulation called Stochastic Resonance Electric Stimulation on leg muscles helps improve balance during tasks like standing up, walking, turning around, and sitting down. Participants will perform these activities while receiving imperceptible electric stimulation to enhance sensory perception.
What are the potential side effects?
Since the electrical stimulation is very low intensity and cannot be felt by participants, no significant side effects are expected. However, there may be minimal risks associated with any form of electrical treatment such as skin irritation at the site of electrode placement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 assessment points: baseline - pre stimulation com, and at the end of the session with stimulation (day 1)- post stimulation com
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 assessment points: baseline - pre stimulation com, and at the end of the session with stimulation (day 1)- post stimulation com
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in COM
Change in COP
Total time
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Stochastic Resonance stimulationExperimental Treatment1 Intervention
During this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test while receiving stochastic resonance stimulation on legs and hip.
Group II: No Stochastic Resonance stimulationActive Control1 Intervention
During this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test without receiving any electrical stimulation.
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Who is running the clinical trial?
University of DelawareLead Sponsor
161 Previous Clinical Trials
25,640 Total Patients Enrolled
5 Trials studying Cerebral Palsy
262 Patients Enrolled for Cerebral Palsy
Samuel Lee, PT, PhDPrincipal InvestigatorUniversity of Dealware
2 Previous Clinical Trials
52 Total Patients Enrolled
2 Trials studying Cerebral Palsy
52 Patients Enrolled for Cerebral Palsy
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have mild to moderate motor function.You do not have any diagnosed neurological or balance disorders.You must be between 8 and 24 years old.You have not had any seizures.The hip migration index is less than 40%, meaning the femoral head does not cover enough of the acetabulum.You have good enough thinking, communication and visual skills.You have not had any seizures or your seizures are well controlled.You have been diagnosed with CP (cerebral palsy).You can move your foot upwards at least a little bit.You do not have any other serious conditions affecting your muscles or bones.You can stand up from a chair and start walking.You are between 8 and 24 years old.You can tell others when you are in pain or feeling uncomfortable.
Research Study Groups:
This trial has the following groups:- Group 1: Stochastic Resonance stimulation
- Group 2: No Stochastic Resonance stimulation
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.
Cerebral Palsy Patient Testimony for trial: Trial Name: NCT05384990 — N/A
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