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Completed

NCT Number: NCT02319122

A Prospective Study of Two Home Based Muscle Strengthening Programs for Children With Cerebral Palsy

The aim of this randomized, stratified, single-blinded study is to compare two home based strength-training protocols (High Intensity Interval Training and Progressive Resistance Training) and their effects on muscle strength, gait and aerobic and anaerobic capacity in children with cerebral palsy.

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Key information

Conditions

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

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LKH Graz - Department of Pediatric and Adolescent Surgery

Graz, Styria, 8036, Austria

About this study

Cerebral palsy is a common neuro-developmental disorder. Among other signs of upper motor neuron syndrome, walking pathologies and muscle weakness are leading signs of disability in children with cerebral palsy. Moreover, the gradual decline in muscle strength is part of the aging process and can be particularly devastating for people with motor disabilities. Therefore muscle-strengthening programs are indicated for children with cerebral palsy. There is evidence that lower extremity muscle strength can be increased by Progressive Resistance Training (PRT) in children with cerebral palsy. However, PRT is time consuming and therefore not always feasible for children with neurologic disorders. Moreover, it does not influence the anaerobic capacity needed for everyday activities in children. High Intensity Interval Training (HIIT) is a time efficient method, which increases both aerobic and anaerobic capacities. The aim of this randomized, stratified, single-blinded study is to compare two home based strength-training protocols (HIIT and PRT) and their effects on muscle strength, gait and aerobic and anaerobic capacity in children with cerebral palsy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ambulatory children with unilateral or bilateral spastic cerebral palsy
  • Age between 8-16 years
  • Ability to accept and follow verbal instruction
  • Gross Motor Function Classification System (GMFCS) at level I-II
  • Willingness to participate

Exclusion criteria

  • Other than spastic form of cerebral palsy (ataxia, athetoid or dystonic)
  • Quadriplegia
  • History of orthopaedic surgery in the last 12 months
  • History of Botulinum Toxin A application in the last 6 months
  • Severe mental retardation

Treatment and study plan

High Intensity Interval Training

Other

See arm description

Other names: HIIT

Progressive resistance training

Other

See arm description

Other names: PRT

Primary outcomes

  1. Change in time for 6 minute Walk Test

    Time frame: between baseline and 2 months later (end of intervention)

    The 6 minute walk test is a self-paced, submaximal test that assesses functional capacity for walking a prolonged distance. The distance reached within 6 minutes of walking is evaluated.

Secondary outcomes

  1. Change in time for Muscle Power Sprint Test

    Time frame: between baseline and 2 months later (end of intervention)

    Short-term muscle power will be measured using the mean power (in watts) derived from the Muscle Power Sprint Test. This test has been shown to be reliable in children with cerebral palsy. For the test, the children are instructed to complete six 15m runs at maximum pace. Between each run, the child is allowed a timed 10 second rest. Mean power output (in watts) is calculated based on the child's body weight and the average time taken to perform the six all-out sprints.

  2. Change in Range of Motion measurements (Goniometer)

    Time frame: between baseline and 2 months later (end of intervention)

    Range of Motion measurements for both lower limbs.

  3. Change in Spasticity measurements (Modified Ashworth Scale)

    Time frame: between baseline and 2 months later (end of intervention)

    Spasticity measurements for both lower limbs.

  4. Change in time for Timed Up and Go Test

    Time frame: between baseline and 2 months later (end of intervention)

    The test requires the children to rise from an armchair stand momentarily, walk 3 meters, return to the same seat and sit down again.

  5. Change in time for Timed Stair Test

    Time frame: between baseline and 2 months later (end of intervention)

    The Timed Stair Test (TST) assesses the time needed to go up and down stairs. The test is performed on a 4 or 5-step set of stairs, with handrails on both sides.

  6. Change in Energy Expenditure Index

    Time frame: between baseline and 2 months later (end of intervention)

    Heart rate is an accurate and convenient measure of energy expenditure during submaximal work in normally developing children and in children with cerebral palsy and other developmental disabilities.

  7. Change in hand held dynamometer muscle strength measurements

    Time frame: between baseline and 2 months later (end of intervention)

    Hand-held dynamometry (HHD) is used to quantify subjects' isometric muscle force production.

  8. Change in Results of Dynamometry, Ultrasound imaging, Electromyography - Analysis of the muscle-tendon unit morphology and physiology measurements of the calf muscles

    Time frame: between baseline and 2 months later (end of intervention)

    After recording, the ultrasound images will be utilized to determine the muscle belly length, fascicle length, pennation angle and muscle thickness of the GM, muscle and tendon excursion, Achilles tendon length and cross-sectional-area (CSA) to calculate muscle and tendon stiffness and Young's modulus of the tendon.

  9. Change in metabolomics data

    Time frame: between baseline and 2 months later (end of intervention)

    A metabolic profile will provide detailed information on the change in energy metabolism.

  10. Change in results of Pediatric Outcome Data Collection Instrument (PODCI) and Activity Scale for kids performance version (ASKp) questionnaires

    Time frame: between baseline and 2 months later (end of intervention)

    Questionnaires measuring the childrens participation and activities of daily living (ADLs)

  11. Change of 3D Gait Analysis data

    Time frame: between baseline and 2 months later (end of intervention)

    Today three dimensional segment models allow the quantification of segment and joint motions of the lower limbs in the three major planes of movement. In addition to the joint-angle and segment-position information, kinetic parameters such as joint moments and forces can be approximated.

Sponsors and collaborators

Lead sponsor

Svehlik Martin, MD PhD

Other

Collaborators

  • University of Graz

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 18, 2014
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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