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Exercise Training for Cerebral Palsy (FOLIC Trial)
N/A
Recruiting
Led By Harshvardhan Singh
Research Sponsored by University of Alabama at Birmingham
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 week 6
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a new exercise plan can help teens with cerebral palsy be more active.
Who is the study for?
This trial is for adolescents with spastic cerebral palsy who can follow verbal instructions and walk on their own. They should be willing to fully participate in the study. Those with recent surgeries, injections in the lower limb, or other health issues that could affect exercise shouldn't apply.
What is being tested?
The study is testing a new exercise program designed to improve physical activity levels in teens with cerebral palsy. It involves loaded high intensity training and high intensity circuit training (HICT) to see if these methods are practical and effective.
What are the potential side effects?
While specific side effects aren't listed, intense physical training may lead to muscle soreness, fatigue, joint stress or injury especially in individuals with muscular disorders like cerebral palsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Physical Activity
Secondary study objectives
Four square step test
Jumping test
Muscle Stiffness
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: Loaded high intensity circuit trainingExperimental Treatment1 Intervention
These participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. From the week 2-5 of the intervention, the participants will perform the exercises with an adjustable weight vest starting with 2.5% to finally reaching 10% of their body weight.
Group II: High Intensity TrainingActive Control1 Intervention
These participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions.
Group III: ControlActive Control1 Intervention
They will continue their standard-of-care plan and will not involve in any new structured exercise program for 6 weeks.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,348 Total Patients Enrolled
7 Trials studying Cerebral Palsy
336 Patients Enrolled for Cerebral Palsy
Harshvardhan SinghPrincipal InvestigatorUniversity of Alabama at Birmingham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had leg surgery or Botox injections in my leg in the last 6 months.I do not have major heart, lung, vision, hearing, or physical issues affecting study participation.I have no diseases that limit my physical activity.I have been diagnosed with spastic cerebral palsy.I can walk by myself without help.
Research Study Groups:
This trial has the following groups:- Group 1: High Intensity Training
- Group 2: Loaded high intensity circuit training
- Group 3: Control
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.
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