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Power Training Combined With Interval Treadmill Training (PT³)

Louisiana State University logo

Louisiana State University

Status

Completed

Conditions

Central Nervous System Diseases
Cerebral Palsy
Brain Damage, Chronic

Treatments

Behavioral: Strength training combined with traditional treadmill training
Behavioral: Power training combined with interval treadmill training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03625570
R01HD091089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

PT³
Experimental group
Description:
Power Training combined with interval treadmill training
Treatment:
Behavioral: Power training combined with interval treadmill training
Traditional training
Active Comparator group
Description:
Strength training combined with traditional treadmill training
Treatment:
Behavioral: Strength training combined with traditional treadmill training

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Noelle G Moreau, PhD

Data sourced from clinicaltrials.gov

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