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RLIC for Cerebral Palsy (I-C-FUN Trial)
N/A
Waitlist Available
Led By Swati M Surkar, PT, PhD
Research Sponsored by East Carolina University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-intervention to 1 month post-intervention follow-up
Awards & highlights
I-C-FUN Trial Summary
This trial will investigate if a non-invasive treatment can improve power, balance, and walking in children with cerebral palsy.
I-C-FUN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-intervention to 1 month post-intervention follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-intervention to 1 month post-intervention follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Balance Score
Change in Peak knee extension power
Change in Walking Speed
Secondary outcome measures
Gait Analysis
Lower limb activity
Quadriceps Electromyography
I-C-FUN Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Remote Limb Ischemic Conditioning (RLIC)Experimental Treatment4 Interventions
RLIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 200 mmHg on the more involved thigh. RLIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RLIC is performed on visits 1-14.
Interventions:
Behavioral: RLIC
Behavioral: Muscle power training
Behavioral: Balance training
Behavioral: Treadmill training
Group II: Sham ConditioningPlacebo Group4 Interventions
Sham conditioning is achieved via blood pressure cuff inflation to 25 mmHg on the more involved thigh. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 1-14.
Interventions:
Behavioral: RLIC
Behavioral: Muscle power training
Behavioral: Balance training
Behavioral: Treadmill training
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treadmill Training
2009
Completed Phase 1
~140
Balance training
2014
Completed Phase 1
~790
RLIC
2021
Completed Phase 1
~140
Muscle Power training
2021
N/A
~30
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Who is running the clinical trial?
East Carolina UniversityLead Sponsor
107 Previous Clinical Trials
38,785 Total Patients Enrolled
2 Trials studying Cerebral Palsy
76 Patients Enrolled for Cerebral Palsy
Swati M Surkar, PT, PhDPrincipal InvestigatorAssistant Professor, East Carolina University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age cutoff for participating in this research under fifty years old?
"This clinical trial is only open to applicants between 6 and 16 years of age. 140 studies are available for those below 18, while 26 trials can be accessed by persons over 65."
Answered by AI
Is my participation in this investigation possible?
"The principal investigators are seeking 24 test subjects aged between 6 and 16 years old that possess a cerebral palsy diagnosis. Additionally, the participants must fit within GMFCS levels I-III while having either unilateral or diplegia CP."
Answered by AI
Is there still an opportunity to join this clinical investigation?
"According to clinicaltrials.gov, this trial is open for recruitment as of the date of writing and was originally posted on June 15th 2021 with a later revision made on September 28th 2021."
Answered by AI
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