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Power + Interval Treadmill Training for Cerebral Palsy (PT³ Trial)
N/A
Waitlist Available
Led By Noelle G Moreau, PT, PhD
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of bilateral spastic Cerebral Palsy (CP)
GMFCS levels I, II, or III
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 2 months and 6 months post training
Awards & highlights
PT³ Trial Summary
This trial is studying the effect of lower extremity Power Training combined with interval Treadmill Training (PT³) on functional walking capacity and community-based activity and participation in children with cerebral palsy (CP).
Who is the study for?
This trial is for children aged 10-17 with bilateral spastic Cerebral Palsy, who can walk but have limitations. They should be classified as GMFCS levels I to III and not have had recent orthopedic or neurosurgery, nor injection therapies like botulinum toxin within the last few months.Check my eligibility
What is being tested?
The study tests a new approach combining muscle power training with interval treadmill exercises tailored for kids' walking patterns. It aims to improve their walking ability and daily life participation by focusing on developing lower extremity strength in a way that's appropriate for their developmental stage.See study design
What are the potential side effects?
While specific side effects are not listed, exercise programs may cause muscle soreness, fatigue, or discomfort initially. The intensity of these side effects typically decreases over time as the body adapts to the training regimen.
PT³ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with bilateral spastic Cerebral Palsy.
Select...
I can walk with or without walking aids.
Select...
I am between 10 and 17 years old.
PT³ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 2 months and 6 months post training
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 2 months and 6 months post training
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Fast gait speed
Secondary outcome measures
Change in 1RM (muscle strength)
Change in Average strides per day
Change in Cross-sectional area
+7 morePT³ Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PT³Experimental Treatment1 Intervention
Power Training combined with interval treadmill training
Group II: Traditional trainingActive Control1 Intervention
Strength training combined with traditional treadmill training
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Power training combined with interval treadmill training
2019
N/A
~50
Find a Location
Who is running the clinical trial?
University of WashingtonOTHER
1,749 Previous Clinical Trials
1,839,958 Total Patients Enrolled
10 Trials studying Cerebral Palsy
1,161 Patients Enrolled for Cerebral Palsy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,978 Previous Clinical Trials
2,680,310 Total Patients Enrolled
29 Trials studying Cerebral Palsy
8,715 Patients Enrolled for Cerebral Palsy
Louisiana State University Health Sciences Center in New OrleansLead Sponsor
115 Previous Clinical Trials
44,020 Total Patients Enrolled
2 Trials studying Cerebral Palsy
84 Patients Enrolled for Cerebral Palsy
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had orthopedic or brain/spine surgery in the last year.I cannot fully straighten my knee.I have been diagnosed with bilateral spastic Cerebral Palsy.I can walk with or without walking aids.I am between 10 and 17 years old.I have not had injections like Botox in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: PT³
- Group 2: Traditional training
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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