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Power Training Combined With Interval Treadmill Training (PT³)

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ClinicalTrials.gov Identifier: NCT03625570
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Washington
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Central Nervous System Diseases Brain Damage, Chronic Behavioral: Power training combined with interval treadmill training Behavioral: Strength training combined with traditional treadmill training Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Power Training Combined With Interval Treadmill Training to Improve Walking Activity in Cerebral Palsy (PT³)
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy

Arm Intervention/treatment
Experimental: PT³
Power Training combined with interval treadmill training
Behavioral: Power training combined with interval treadmill training
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.

Active Comparator: Traditional training
Strength training combined with traditional treadmill training
Behavioral: Strength training combined with traditional treadmill training
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.




Primary Outcome Measures :
  1. Change in Self-selected gait speed [ Time Frame: Baseline and immediate post training ]
    Calculated from the 10 meter walk test in meters/second at self-selected speed

  2. Change in Peak power [ Time Frame: Baseline and immediate post training ]
    Product of force x velocity

  3. Change in Average strides per day [ Time Frame: Baseline and immediate post training ]
    Average strides/day as captured by Step Watch accelerometer as worn for 5 days (Community walking activity level)


Secondary Outcome Measures :
  1. Change in Self-selected gait speed [ Time Frame: Baseline and 2 months and 6 months post training ]
    Calculated from the 10 meter walk test in meters/second at self-selected speed

  2. Change in Peak power [ Time Frame: Baseline and 2 months post training and 6 months post training ]
    Product of force x velocity

  3. Change in Average strides per day [ Time Frame: Baseline and 2 months post training and 6 months post training ]
    Average strides/day as captured by Step Watch accelerometer as worn for 5 days (Community walking activity level)

  4. Change in Fast gait speed (m/s) [ Time Frame: Baseline and immediate post training, 2 months and 6 months post training ]
    Calculated from the 10 meter walk test in meters/second at fast walking speed

  5. Change in One minute walk test (m) [ Time Frame: Baseline and immediate post training, 2 months and 6 months post training ]
    Distance covered while walking as fast as possible for 1 minute measured in meters

  6. Change in Cross-sectional area [ Time Frame: Baseline and immediate post training, 2 months and 6 months post training ]
    Ultrasound image of cross-sectional area of rectus femoris at 50% distance between anterior superior iliac spine and apex of patella

  7. Change in Isokinetic muscle strength [ Time Frame: Baseline and immediate post training, 2 months and 6 months post training ]
    Isokinetic dynamometer (Biodex System 3) according to published standard procedures for isokinetic strength. Calculated for knee extensors, ankle plantarflexors.

  8. Change in Walking intensity - stride rates (strides/minute) [ Time Frame: Baseline and immediate post training, 2 months and 6 months post training ]
    Average strides/day in low (1 to 30 strides/min), medium (31 to 60 stride/min), and high (> 60 stride/min) stride rates as captured by Step Watch accelerometer as worn for 5 days.

  9. Change in Patient-Reported Outcomes Measurement Information System (PROMIS v2.0 Pediatric Profile 49 [ Time Frame: Baseline and immediate post training, 2 months and 6 months post training ]
    Patient-Reported Outcomes from NINDS Common Data Elements - CP; The PROMIS item bank was developed from patient-reported outcome measures that indicate patients' state of well-being and functional abilities



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625570


Contacts
Contact: Noelle G Moreau, PhD 504-568-4291 nmorea@lsuhsc.edu

Locations
United States, Louisiana
Louisiana State University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Noelle G Moreau, PT, PhD    504-568-4291    nmorea@lsuhsc.edu   
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98121
Contact: Kristie Bjornson, PT, PhD    206-884-2066    kristie.bjornson@seattlechildrens.org   
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Washington
Investigators
Principal Investigator: Noelle G Moreau, PT, PhD Louisiana State University Health Sciences Center - New Orleans

Responsible Party: Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT03625570     History of Changes
Other Study ID Numbers: R01HD091089 ( U.S. NIH Grant/Contract )
R01HD091089 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
muscle weakness
muscle power
resistance training
treadmill training

Additional relevant MeSH terms:
Cerebral Palsy
Nervous System Diseases
Central Nervous System Diseases
Brain Injuries
Brain Damage, Chronic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries