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

December 21, 2017 updated by: Svehlik Martin, MD PhD
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • LKH Graz - Department of Pediatric and Adolescent Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Progressive Resistance Training

The key for the PRT is the timely progression of load, based on the child's individual level of strength, which ensures progressive overload.

Every training session will consist of a warm up, progressive resistance exercises and a cool down period. During warm up and cool down periods.These exercises will be the same for both training groups.

The strength training exercises have been chosen to strengthen the main lower extremity muscle groups which are important for the gait: sit-to-stand, lateral step-ups, the half knee rise, heel-rises and bridging.

All these exercises are performed loaded according to the individual level. Three sets of 8 to 10 repetitions of each exercise will be practiced on 3 non-consecutive days with moderate velocity.
Other: Progressive Resistance Training
See arm description
Other Names:
  • PRT
OTHER: High Intensity Interval Training
The High Intensity Circuit Training is a sub form of High Intensity Interval Training. The key feature is the very little rest between the exercises which causes a consistent elevation of the participant's heart rate and a short duration of the whole exercise session. Every training session consists of a warm-up, a circuit of 5 exercises (the same as these in the PRT group) and a cool-down period. The children will be asked to train 3 times a week on non-consecutive days and to perform 3 sets. Exercise workload is controlled by determination of time intervals (30 seconds). The children will be instructed to perform as many repetitions as possible during the exercise interval and to keep the rest between the exercises short (it must not exceed 30 seconds).
Other: High Intensity Interval Training
See arm description
Other Names:
  • HIIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
between baseline and 2 months later (end of intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
between baseline and 2 months later (end of intervention)
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.
between baseline and 2 months later (end of intervention)
Change in Spasticity measurements (Modified Ashworth Scale)
Time Frame: between baseline and 2 months later (end of intervention)
Spasticity measurements for both lower limbs.
between baseline and 2 months later (end of intervention)
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.
between baseline and 2 months later (end of intervention)
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.
between baseline and 2 months later (end of intervention)
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.
between baseline and 2 months later (end of intervention)
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.
between baseline and 2 months later (end of intervention)
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.
between baseline and 2 months later (end of intervention)
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.
between baseline and 2 months later (end of intervention)
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)
between baseline and 2 months later (end of intervention)
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.
between baseline and 2 months later (end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Svehlik Martin, MD PhD

Collaborators

University of Graz

Investigators

  • Principal Investigator: Martin Svehlik, MD, PhD, LKH-Univ.Klinikum Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

July 14, 2017

Study Completion (ACTUAL)

July 14, 2017

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 12, 2014

First Posted (ESTIMATE)

December 18, 2014

Study Record Updates

Last Update Posted (ACTUAL)

December 26, 2017

Last Update Submitted That Met QC Criteria

December 21, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-526 ex 13/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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