Power Training Combined With Interval Treadmill Training

NCT03625570 | Completed Results DMC

• 1 other identifier: R01HD091089
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy; Central Nervous System Diseases; Brain Damage, Chronic

Keywords

muscle weakness; muscle power; resistance training; treadmill training

Outcome Measures

Primary Outcomes (4)

• Change in Self-selected Gait Speed (Normalized)

  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.

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

• Change in Fast Gait Speed (Normalized)

  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.

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

• Change in Peak Power

  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

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

• Change in Average Strides Per Day

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

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

Secondary Outcomes (10)

• 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)

Study Arms (2)

PT³

EXPERIMENTAL

Power Training combined with interval treadmill training

Behavioral: Power training combined with interval treadmill training

Traditional training

ACTIVE COMPARATOR

Strength training combined with traditional treadmill training

Behavioral: Strength training combined with traditional treadmill training

Interventions

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.

PT³

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.

Traditional training

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of bilateral spastic Cerebral Palsy (CP)
• Age 10 to 17 years inclusive
• GMFCS levels I, II, or III

You may not qualify if:

• 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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Washington: collaborator

Study Sites (2)

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98121, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Central Nervous System Diseases; Brain Damage, Chronic; Muscle Weakness

Condition Hierarchy (Ancestors)

Brain Diseases; Nervous System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Noelle G. Moreau
• Organization: Louisiana State University Health Sciences Center - New Orleans

nmorea@lsuhsc.edu

504-568-4291

Study Officials

• Noelle G Moreau, PT, PhD

  Louisiana State University Health Sciences Center - New Orleans

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 10, 2018
• Study Start: April 15, 2019
• Primary Completion: October 4, 2023
• Study Completion: November 10, 2023
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)