Clinical trial NCT02319122: A Prospective Study of Two Home Based Muscle Strengthening Programs for Children With Cerebral Palsy
Official title: A Prospective Study of Two Home Based Muscle Strengthening Programs for Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Muscle structure
Strength training
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: University of Graz
First posted: 2014-12-18
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in time for 6 minute Walk Test
timeFrame: between baseline and 2 months later (end of intervention)
Secondary outcomes:
measure: Change in time for Muscle Power Sprint Test
timeFrame: between baseline and 2 months later (end of intervention)
measure: Change in Range of Motion measurements (Goniometer)
timeFrame: between baseline and 2 months later (end of intervention)
measure: Change in Spasticity measurements (Modified Ashworth Scale)
timeFrame: between baseline and 2 months later (end of intervention)
measure: Change in time for Timed Up and Go Test
timeFrame: between baseline and 2 months later (end of intervention)
measure: Change in time for Timed Stair Test
timeFrame: between baseline and 2 months later (end of intervention)
measure: Change in Energy Expenditure Index
timeFrame: between baseline and 2 months later (end of intervention)
measure: Change in hand held dynamometer muscle strength measurements
timeFrame: between baseline and 2 months later (end of intervention)
measure: Change in Results of Dynamometry, Ultrasound imaging, Electromyography - Analysis of the muscle-tendon unit morphology and physiology measurements of the calf muscles
timeFrame: between baseline and 2 months later (end of intervention)
measure: Change in metabolomics data
timeFrame: between baseline and 2 months later (end of intervention)
measure: Change in results of Pediatric Outcome Data Collection Instrument (PODCI) and Activity Scale for kids performance version (ASKp) questionnaires
timeFrame: between baseline and 2 months later (end of intervention)
measure: Change of 3D Gait Analysis data
timeFrame: between baseline and 2 months later (end of intervention)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH Graz - Department of Pediatric and Adolescent Surgery
state: Styria
Study officials:
affiliation: LKH-Univ.Klinikum Graz
name: Martin Svehlik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Schranz C, Kruse A, Tilp M, Svehlik M. Is there a relationship between muscle-tendon properties and a variety of functional tasks in children with spastic cerebral palsy? Gait Posture. 2021 Mar;85:14-19. doi: 10.1016/j.gaitpost.2021.01.009. Epub 2021 Jan 14.
citation: Schranz C, Kruse A, Belohlavek T, Steinwender G, Tilp M, Pieber T, Svehlik M. Does Home-Based Progressive Resistance or High-Intensity Circuit Training Improve Strength, Function, Activity or Participation in Children With Cerebral Palsy? Arch Phys Med Rehabil. 2018 Dec;99(12):2457-2464.e4. doi: 10.1016/j.apmr.2018.06.010. Epub 2018 Jul 4.