Power Training Combined With Interval Treadmill Training (PT³)
Primary Purpose
Cerebral Palsy, Central Nervous System Diseases, Brain Damage, Chronic
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Power training combined with interval treadmill training
Strength training combined with traditional treadmill training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring muscle weakness, muscle power, resistance training, treadmill training
Eligibility Criteria
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
Sites / Locations
- Louisiana State University Health Sciences CenterRecruiting
- Seattle Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PT³
Traditional training
Arm Description
Power Training combined with interval treadmill training
Strength training combined with traditional treadmill training
Outcomes
Primary Outcome Measures
Change in Self-selected gait speed
Calculated from the 10 meter walk test in meters/second at self-selected speed
Change in Peak power
Product of force x velocity
Change in Average strides per day
Average strides/day as captured by Step Watch accelerometer as worn for 5 days (Community walking activity level)
Secondary Outcome Measures
Change in Self-selected gait speed
Calculated from the 10 meter walk test in meters/second at self-selected speed
Change in Peak power
Product of force x velocity
Change in Average strides per day
Average strides/day as captured by Step Watch accelerometer as worn for 5 days (Community walking activity level)
Change in Fast gait speed (m/s)
Calculated from the 10 meter walk test in meters/second at fast walking speed
Change in One minute walk test (m)
Distance covered while walking as fast as possible for 1 minute measured in meters
Change in Cross-sectional area
Ultrasound image of cross-sectional area of rectus femoris at 50% distance between anterior superior iliac spine and apex of patella
Change in Isokinetic muscle strength
Isokinetic dynamometer (Biodex System 3) according to published standard procedures for isokinetic strength. Calculated for knee extensors, ankle plantarflexors.
Change in Walking intensity - stride rates (strides/minute)
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.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS v2.0 Pediatric Profile 49
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
Change in 1RM (muscle strength)
1repetition maximum (1RM) testing on a leg press
Full Information
NCT ID
NCT03625570
First Posted
August 1, 2018
Last Updated
April 28, 2021
Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT03625570
Brief Title
Power Training Combined With Interval Treadmill Training
Acronym
PT³
Official Title
Power Training Combined With Interval Treadmill Training to Improve Walking Activity in Cerebral Palsy (PT³)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Louisiana State University Health Sciences Center in New Orleans
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Ambulatory children with cerebral palsy (CP) experience walking limitations which negatively influence their ability to physically participate in day to day life. The investigators propose that impaired muscle power generation is the key limiting factor affecting walking activity and participation. This proposal represents a combined approach where participants undergo resistance training for muscle power generation in combination with locomotor treadmill training that is based on typical pediatric walking and activity patterns rather than adult protocols, which are endurance or time-based. Therefore, the primary objective of this randomized controlled trial is to determine 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 CP. We hypothesize that remediating the most pronounced muscle performance impairment (i.e., muscle power) with power training combined with a task- specific approach to walking that is developmentally appropriate will have a significant effect on walking capacity and performance.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Central Nervous System Diseases, Brain Damage, Chronic
Keywords
muscle weakness, muscle power, resistance training, treadmill training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PT³
Arm Type
Experimental
Arm Description
Power Training combined with interval treadmill training
Arm Title
Traditional training
Arm Type
Active Comparator
Arm Description
Strength training combined with traditional treadmill training
Intervention Type
Behavioral
Intervention Name(s)
Power training combined with interval treadmill training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strength training combined with traditional treadmill training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Self-selected gait speed
Description
Calculated from the 10 meter walk test in meters/second at self-selected speed
Time Frame
Baseline and immediate post training
Title
Change in Peak power
Description
Product of force x velocity
Time Frame
Baseline and immediate post training
Title
Change in Average strides per day
Description
Average strides/day as captured by Step Watch accelerometer as worn for 5 days (Community walking activity level)
Time Frame
Baseline and immediate post training
Secondary Outcome Measure Information:
Title
Change in Self-selected gait speed
Description
Calculated from the 10 meter walk test in meters/second at self-selected speed
Time Frame
Baseline and 2 months and 6 months post training
Title
Change in Peak power
Description
Product of force x velocity
Time Frame
Baseline and 2 months post training and 6 months post training
Title
Change in Average strides per day
Description
Average strides/day as captured by Step Watch accelerometer as worn for 5 days (Community walking activity level)
Time Frame
Baseline and 2 months post training and 6 months post training
Title
Change in Fast gait speed (m/s)
Description
Calculated from the 10 meter walk test in meters/second at fast walking speed
Time Frame
Baseline and immediate post training, 2 months and 6 months post training
Title
Change in One minute walk test (m)
Description
Distance covered while walking as fast as possible for 1 minute measured in meters
Time Frame
Baseline and immediate post training, 2 months and 6 months post training
Title
Change in Cross-sectional area
Description
Ultrasound image of cross-sectional area of rectus femoris at 50% distance between anterior superior iliac spine and apex of patella
Time Frame
Baseline and immediate post training, 2 months and 6 months post training
Title
Change in Isokinetic muscle strength
Description
Isokinetic dynamometer (Biodex System 3) according to published standard procedures for isokinetic strength. Calculated for knee extensors, ankle plantarflexors.
Time Frame
Baseline and immediate post training, 2 months and 6 months post training
Title
Change in Walking intensity - stride rates (strides/minute)
Description
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.
Time Frame
Baseline and immediate post training, 2 months and 6 months post training
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS v2.0 Pediatric Profile 49
Description
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
Time Frame
Baseline and immediate post training, 2 months and 6 months post training
Title
Change in 1RM (muscle strength)
Description
1repetition maximum (1RM) testing on a leg press
Time Frame
Baseline and immediate post training, 2 months and 6 months post training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noelle G Moreau, PhD
Phone
504-568-4291
Email
nmorea@lsuhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noelle G Moreau, PT, PhD
Organizational Affiliation
Louisiana State University Health Sciences Center - New Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louisiana State University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noelle G Moreau, PT, PhD
Phone
504-568-4291
Email
nmorea@lsuhsc.edu
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristie Bjornson, PT, PhD
Phone
206-884-2066
Email
kristie.bjornson@seattlechildrens.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Power Training Combined With Interval Treadmill Training
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