Power Training Combined With Interval Treadmill Training (PT³)

Power Training Combined With Interval Treadmill Training to Improve Walking Activity in Cerebral Palsy (PT³)

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.

Study Overview

• Status: Completed
• Conditions: Central Nervous System Diseases; Cerebral Palsy; Brain Damage, Chronic
• Intervention / Treatment: Behavioral: Power training combined with interval treadmill training; Behavioral: Strength training combined with traditional treadmill training

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: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Sciences Center
  • Washington
    • Seattle, Washington, United States, 98121
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PT³; Power Training combined with interval treadmill training	Behavioral: 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	Behavioral: 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 (Normalized)	Calculated from the 10 meter walk test in meters/second at self-selected speed and then normalized by stature to yield non-dimensional units. Higher values represent faster gait speeds.	Baseline and immediate post training (8-10 weeks post baseline)
Change in Fast Gait Speed (Normalized)	Calculated from the 10 meter walk test in meters/second at fast walking speed and then normalized by stature to yield non-dimensional units. Higher values equal faster gait speeds.	Baseline and immediate post training (8-10 weeks post baseline)
Change in Peak Power	Lower extremity peak power produced during a power leg press test averaged over 5 trials; product of force x velocity; adjusted for sled angle and body mass	Baseline and immediate post training (8-10 weeks post baseline)
Change in Average Strides Per Day	Average number of strides walked per day captured by Step Watch accelerometer as worn for a minimum of 4 days	Baseline and immediate post training (8-10 weeks post baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Self-selected Gait Speed (Normalized)	Calculated from the 10 meter walk test in meters/second at self-selected speed and then normalized by stature to yield non-dimensional units. Higher values equal faster speeds.	Baseline and 2 months post training (16 weeks post baseline)
Change in Fast Gait Speed (Normalized)	Calculated from the 10 meter walk test in meters/second at fast walking speed and then normalized by stature to yield non-dimensional units. Higher values equal faster speeds.	Baseline and 2 months post training (16 weeks post baseline)
Change in Peak Power	Lower extremity peak power produced during a power leg press test averaged over 5 trials; product of force x velocity; adjusted for sled angle and body mass	Baseline and 2 months post training (16 weeks post baseline)
Change in Average Strides Per Day	Average number of strides walked per day captured by Step Watch accelerometer as worn for a minimum of 4 days	Baseline and 2 months post training (16 weeks post baseline)
Change in One Minute Walk Test	Distance covered while walking as fast as possible for 1 minute measured in meters	Baseline and immediate post training (8-10 weeks post baseline)
Change in Cross-sectional Area	Cross-sectional area of rectus femoris taken at 50% distance between anterior superior iliac spine and apex of patella using 2D Bmode Ultrasound imaging in cm^2; Average of Right and Left Sides	Baseline and immediate post training (8-10 weeks post baseline)
Change in Isokinetic Muscle Strength of Knee Extensors	Isokinetic dynamometer (Biodex System 3/4) according to published standard procedures for isokinetic strength. Calculated for knee extensors at 60 degrees/second in newton-meters	Baseline and immediate post training (8-10 weeks post baseline)
Change in Walking Intensity at Medium and High Stride Rates (Strides/Minute)	Average strides/day at medium (31 to 60 stride/min) and high (> 60 stride/min) stride rates as captured by Step Watch accelerometer as worn for a minimum of 4 days	Baseline and immediate post training (8-10 weeks post baseline)
Change in Patient-Reported Outcomes Measurement Information System Physical Function-Mobility (PROMIS v2.0 Pediatric Profile 49 - Physical Function-Mobility)	Patient-Reported Outcomes Measurement Information System (PROMIS); The PROMIS item bank was developed from patient-reported outcome measures that indicate patients' state of well-being and functional abilities. The results of the Physical Function-Mobility domain are reported here as the Change in the T-score from baseline to 8-10wks post baseline. The T-score is a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured so for a positive concept, such as Physical Function-Mobility, a higher T-score or 'change' in the T-score represents higher physical functioning and mobility.	Baseline and immediate post training (8-10 weeks post baseline)
Change in 1RM (Muscle Strength)	1repetition maximum (1RM) testing on a leg press reported in lbs; external load reported after adjusting for the angle of the press	Baseline and immediate post training (8-10 weeks post baseline)

Collaborators and Investigators

• 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
• 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): April 15, 2019
• Primary Completion (Actual): October 4, 2023
• Study Completion (Actual): November 10, 2023

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: muscle weakness; resistance training; muscle power; treadmill training
• Additional Relevant MeSH Terms: Brain Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Cerebral Palsy; Nervous System Diseases; Central Nervous System Diseases; Brain Damage, Chronic
• Other Study ID Numbers: R01HD091089 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No