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Completed

NCT Number: NCT03625570

Power Training Combined With Interval Treadmill Training

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Chronic Disease Disease Attributes Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louisiana State University Health Sciences Center, New Orleans, Louisiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Power training combined with interval treadmill training

Behavioral

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.

Strength training combined with traditional treadmill training

Behavioral

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 outcomes

  1. Change in Self-selected Gait Speed (Normalized)

    Time frame: Baseline and immediate post training (8-10 weeks post baseline)

    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.

  2. Change in Fast Gait Speed (Normalized)

    Time frame: Baseline and immediate post training (8-10 weeks post baseline)

    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.

  3. Change in Peak Power

    Time frame: Baseline and immediate post training (8-10 weeks post baseline)

    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

  4. Change in Average Strides Per Day

    Time frame: Baseline and immediate post training (8-10 weeks post baseline)

    Average number of strides walked per day captured by Step Watch accelerometer as worn for a minimum of 4 days

Secondary outcomes

  1. Change in Self-selected Gait Speed (Normalized)

    Time frame: Baseline and 2 months post training (16 weeks post baseline)

    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.

  2. Change in Fast Gait Speed (Normalized)

    Time frame: Baseline and 2 months post training (16 weeks post baseline)

    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.

  3. Change in Peak Power

    Time frame: Baseline and 2 months post training (16 weeks post baseline)

    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

  4. Change in Average Strides Per Day

    Time frame: Baseline and 2 months post training (16 weeks post baseline)

    Average number of strides walked per day captured by Step Watch accelerometer as worn for a minimum of 4 days

  5. Change in One Minute Walk Test

    Time frame: Baseline and immediate post training (8-10 weeks post baseline)

    Distance covered while walking as fast as possible for 1 minute measured in meters

  6. Change in Cross-sectional Area

    Time frame: Baseline and immediate post training (8-10 weeks post baseline)

    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

  7. Change in Isokinetic Muscle Strength of Knee Extensors

    Time frame: Baseline and immediate post training (8-10 weeks post baseline)

    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

  8. Change in Walking Intensity at Medium and High Stride Rates (Strides/Minute)

    Time frame: Baseline and immediate post training (8-10 weeks post baseline)

    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

  9. Change in Patient-Reported Outcomes Measurement Information System Physical Function-Mobility (PROMIS v2.0 Pediatric Profile 49 - Physical Function-Mobility)

    Time frame: Baseline and immediate post training (8-10 weeks post baseline)

    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.

  10. Change in 1RM (Muscle Strength)

    Time frame: Baseline and immediate post training (8-10 weeks post baseline)

    1repetition maximum (1RM) testing on a leg press reported in lbs; external load reported after adjusting for the angle of the press

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Washington

Registry information

Official study title

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

Acronym: PT³

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2018
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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