Power Training Combined With Interval Treadmill Training

Not Applicable

Completed

Conditions: Cerebral Palsy
Central Nervous System Diseases
Brain Damage, Chronic

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

Registration Number: NCT03625570

Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PT³	Power training combined with interval treadmill training	Power Training combined with interval treadmill training
Traditional training	Strength training combined with traditional treadmill training	Strength training combined with traditional treadmill training

Primary Outcome Measures

Name	Time	Method
Change in Self-selected Gait Speed (Normalized)	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.
Change in Fast Gait Speed (Normalized)	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.
Change in Peak Power	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
Change in Average Strides Per Day	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 Outcome Measures

Name	Time	Method
Change in Self-selected Gait Speed (Normalized)	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.
Change in Fast Gait Speed (Normalized)	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.
Change in Peak Power	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
Change in Average Strides Per Day	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
Change in One Minute Walk Test	Baseline and immediate post training (8-10 weeks post baseline)	Distance covered while walking as fast as possible for 1 minute measured in meters
Change in Cross-sectional Area	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
Change in Isokinetic Muscle Strength of Knee Extensors	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
Change in Walking Intensity at Medium and High Stride Rates (Strides/Minute)	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
Change in Patient-Reported Outcomes Measurement Information System Physical Function-Mobility (PROMIS v2.0 Pediatric Profile 49 - Physical Function-Mobility)	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.
Change in 1RM (Muscle Strength)	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

Trial Locations

Locations (2): Seattle Children's Hospital
🇺🇸
Seattle, Washington, United States
Louisiana State University Health Sciences Center
🇺🇸
New Orleans, Louisiana, United States