Clinical trial NCT03625570: Power Training Combined With Interval Treadmill Training
Official title: Power Training Combined With Interval Treadmill Training to Improve Walking Activity in Cerebral Palsy (PT³)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Central Nervous System Diseases
Brain Damage, Chronic
Keywords: muscle weakness
muscle power
resistance training
treadmill training
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Washington
First posted: 2018-08-10
Enrollment: 44
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Self-selected Gait Speed (Normalized)
timeFrame: Baseline and immediate post training (8-10 weeks post baseline)
measure: Change in Fast Gait Speed (Normalized)
timeFrame: Baseline and immediate post training (8-10 weeks post baseline)
measure: Change in Peak Power
timeFrame: Baseline and immediate post training (8-10 weeks post baseline)
measure: Change in Average Strides Per Day
timeFrame: Baseline and immediate post training (8-10 weeks post baseline)
Secondary outcomes:
measure: Change in Self-selected Gait Speed (Normalized)
timeFrame: Baseline and 2 months post training (16 weeks post baseline)
measure: Change in Fast Gait Speed (Normalized)
timeFrame: Baseline and 2 months post training (16 weeks post baseline)
measure: Change in Peak Power
timeFrame: Baseline and 2 months post training (16 weeks post baseline)
measure: Change in Average Strides Per Day
timeFrame: Baseline and 2 months post training (16 weeks post baseline)
measure: Change in One Minute Walk Test
timeFrame: Baseline and immediate post training (8-10 weeks post baseline)
measure: Change in Cross-sectional Area
timeFrame: Baseline and immediate post training (8-10 weeks post baseline)
measure: Change in Isokinetic Muscle Strength of Knee Extensors
timeFrame: Baseline and immediate post training (8-10 weeks post baseline)
measure: Change in Walking Intensity at Medium and High Stride Rates (Strides/Minute)
timeFrame: Baseline and immediate post training (8-10 weeks post baseline)
measure: Change in Patient-Reported Outcomes Measurement Information System Physical Function-Mobility (PROMIS v2.0 Pediatric Profile 49 - Physical Function-Mobility)
timeFrame: Baseline and immediate post training (8-10 weeks post baseline)
measure: Change in 1RM (Muscle Strength)
timeFrame: Baseline and immediate post training (8-10 weeks post baseline)
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Louisiana State University Health Sciences Center - New Orleans
name: Noelle G Moreau, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: