Power Training Combined With Interval Treadmill Training to Improve Walking Activity in Cerebral Palsy (PT³)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 44
- Locations
- 4
- Primary Endpoint
- Change in Self-selected Gait Speed (Normalized)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PT³
Power Training combined with interval treadmill training
Intervention: Power training combined with interval treadmill training (Behavioral)
Traditional training
Strength training combined with traditional treadmill training
Intervention: Strength training combined with traditional treadmill training (Behavioral)
Outcomes
Primary Outcomes
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.
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.
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
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
- Change in Self-selected Gait Speed (Normalized)(Baseline and 2 months post training (16 weeks post baseline))
- Change in Fast Gait Speed (Normalized)(Baseline and 2 months post training (16 weeks post baseline))
- Change in Peak Power(Baseline and 2 months post training (16 weeks post baseline))
- Change in Average Strides Per Day(Baseline and 2 months post training (16 weeks post baseline))
- Change in One Minute Walk Test(Baseline and immediate post training (8-10 weeks post baseline))
- Change in Cross-sectional Area(Baseline and immediate post training (8-10 weeks post baseline))
- Change in Isokinetic Muscle Strength of Knee Extensors(Baseline and immediate post training (8-10 weeks post baseline))
- Change in Walking Intensity at Medium and High Stride Rates (Strides/Minute)(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)(Baseline and immediate post training (8-10 weeks post baseline))
- Change in 1RM (Muscle Strength)(Baseline and immediate post training (8-10 weeks post baseline))