- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03625570
Power Training Combined With Interval Treadmill Training (PT³)
Power Training Combined With Interval Treadmill Training to Improve Walking Activity in Cerebral Palsy (PT³)
Study Overview
Status
Detailed Description
The primary purpose of this randomized controlled trial is to test the effect of Power Training combined with interval Treadmill Training (PT³) on walking capacity and performance in children with CP with walking limitations. To identify key muscular mechanisms associated with improved walking mobility, the effects of PT³ on muscle performance and architecture will be examined. The premise of the PT³ protocol is that a combined impairment and task-specific approach that is developmentally appropriate and targets muscle power deficits specifically, is necessary to drive changes in both clinic and community-based walking activity.
In this randomized multi-site clinical trial, 48 ambulatory participants with CP will receive either PT³ or an equivalent dosage of traditional strength training combined with traditional treadmill training (comparison group) for 24 sessions, 3 times per week for 8 weeks. Outcomes will be collected at baseline and immediately post-treatment. Short and long-term retention effects will be assessed at 2 and 6 months post.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noelle G Moreau, PhD
- Phone Number: 504-568-4291
- Email: nmorea@lsuhsc.edu
Study Locations
-
-
Louisiana
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New Orleans, Louisiana, United States, 70112
- Louisiana State University Health Sciences Center
-
-
Washington
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Seattle, Washington, United States, 98121
- Seattle Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of bilateral spastic Cerebral Palsy (CP)
- Age 10 to 17 years inclusive
- GMFCS levels I, II, or III
Exclusion Criteria:
- Orthopedic or neurosurgery less than 12 months prior to enrollment
- Injection therapies (phenol, botulinum toxin) less than 3 months prior to enrollment
- Lacking greater than 25 degrees of knee extension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PT³
Power Training combined with interval treadmill training
|
Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training.
The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes.
Participants will train 3 x per week for 8 weeks.
Total duration of each session will be approximately 1 hour.
|
Active Comparator: Traditional training
Strength training combined with traditional treadmill training
|
Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength.
Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes.
Participants will train 3 x per week for 8 weeks.
Total duration of each session will be approximately 1 hour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-selected gait speed
Time Frame: Baseline and immediate post training
|
Calculated from the 10 meter walk test in meters/second at self-selected speed
|
Baseline and immediate post training
|
Change in Average strides per day
Time Frame: Baseline and immediate post training
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Average strides/day as captured by Step Watch accelerometer as worn for 5 days (Community walking activity level)
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Baseline and immediate post training
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Change in Fast gait speed
Time Frame: Baseline and immediate post training
|
Calculated from the 10 meter walk test in meters/second at fast walking speed
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Baseline and immediate post training
|
Change in Peak power
Time Frame: Baseline and immediate post training
|
Lower extremity power produced during a power leg press test; product of force x velocity
|
Baseline and immediate post training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-selected gait speed
Time Frame: Baseline and 2 months and 6 months post training
|
Calculated from the 10 meter walk test in meters/second at self-selected speed
|
Baseline and 2 months and 6 months post training
|
Change in Average strides per day
Time Frame: Baseline and 2 months post training and 6 months post training
|
Average strides/day as captured by Step Watch accelerometer as worn for 5 days (Community walking activity level)
|
Baseline and 2 months post training and 6 months post training
|
Change in One minute walk test (m)
Time Frame: Baseline and immediate post training, 2 months and 6 months post training
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Distance covered while walking as fast as possible for 1 minute measured in meters
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Baseline and immediate post training, 2 months and 6 months post training
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Change in Cross-sectional area
Time Frame: Baseline and immediate post training, 2 months and 6 months post training
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Ultrasound image of cross-sectional area of rectus femoris at 50% distance between anterior superior iliac spine and apex of patella
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Baseline and immediate post training, 2 months and 6 months post training
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Change in Isokinetic muscle strength
Time Frame: Baseline and immediate post training, 2 months and 6 months post training
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Isokinetic dynamometer (Biodex System 3) according to published standard procedures for isokinetic strength.
Calculated for knee extensors, ankle plantarflexors.
|
Baseline and immediate post training, 2 months and 6 months post training
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Change in Walking intensity - stride rates (strides/minute)
Time Frame: Baseline and immediate post training, 2 months and 6 months post training
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Average strides/day in low (1 to 30 strides/min), medium (31 to 60 stride/min), and high (> 60 stride/min) stride rates as captured by Step Watch accelerometer as worn for 5 days.
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Baseline and immediate post training, 2 months and 6 months post training
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS v2.0 Pediatric Profile 49
Time Frame: Baseline and immediate post training, 2 months and 6 months post training
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Patient-Reported Outcomes from NINDS Common Data Elements - CP; The PROMIS item bank was developed from patient-reported outcome measures that indicate patients' state of well-being and functional abilities
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Baseline and immediate post training, 2 months and 6 months post training
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Change in 1RM (muscle strength)
Time Frame: Baseline and immediate post training, 2 months and 6 months post training
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1repetition maximum (1RM) testing on a leg press
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Baseline and immediate post training, 2 months and 6 months post training
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Change in Fast gait speed (m/s)
Time Frame: Baseline and 2 months post training and 6 months post training
|
Calculated from the 10 meter walk test in meters/second at fast walking speed
|
Baseline and 2 months post training and 6 months post training
|
Change in Peak power
Time Frame: Baseline and 2 months post training and 6 months post training
|
Lower extremity power produced during a power leg press test; product of force x velocity
|
Baseline and 2 months post training and 6 months post training
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Noelle G Moreau, PT, PhD, Louisiana State University Health Sciences Center - New Orleans
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HD091089 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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