Clinical trial NCT02460406: Progressive Functional Strength Training in Unilateral Spastic Cerebral Palsy
Official title: The Effects of Lower Limb Progressive Functional Strength Training Protocol on Body Functions and Activity in Children With Unilateral Spastic Cerebral Palsy: a Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Hemiplegic Cerebral Palsy
Keywords: strength training
virtual reality
plyometric exercises
cerebral palsy
hemiplegic
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 43
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to investigate effectiveness of progressive functional strength training protocol (functional squat system with virtual reality in leg press, plyometric exercises, exercises with Bosu ball \& heel-rise exercises) on Body Functions and activity in children with unilateral spastic Cerebral Palsy (CP) by applying current guidelines. According to literature, there are studies that investigate the effects of functional strength training in children with CP. But there is no randomized controlled trial, explore the effects of progressive functional strength training protocol on body functions and activity on unilateral spastic CP. Hypothesis of this study is that progressive functional strength training protocol improves performance-related physical fitness, gross motor function, dynamic, balance, muscle tone and muscle strength in unilateral spastic CP.

Detailed description: Cerebral palsy (CP) describes a group of disorders in the development of movement and posture, causing activity limitations, which are attributed to non-progressive disturbances that occurred in the developing brain. It is the most common cause of movement disability in childhood. Children with CP may experience a variety of impaired muscle functions, such as spasticity, muscle weakness, and loss of selective motor control. Muscle structural changes are caused to activate of mechanisms that are limited function with growing and maturation. The weakness found in children with CP is attributable to both altered neural mechanisms and muscle tissue changes. Several factors affect the level of weakness found in the muscles of children with CP. First, weakness may differ between proximal and distal limb muscles. Stackhouse et al. found that the maximum voluntary contraction (MVC) was more impaired in the plantar flexors than the quadriceps of children with mild CP compared with controls. Second, the peak torque may vary according to the velocity of limb movement. Peak torque of the knee flexors and extensors in 24 children with CP was found to decrease with increasing velocity on an isokinetic machine. Third, peak torque may vary according to muscle length. An isokinetic study of 44 children and young people with CP found that peak torque in the hip abductors occurred when the muscle was in a lengthened position with the leg still in adduction. Fourth, the type of contraction was found to consistently affect the peak torque in both children with CP and those who are typically developing, with eccentric force being greater than concentric force in the same muscle. Although all impaired muscle functions limit the performance of daily life activities and participation in a child with CP, a recent study has shown that muscle weakness showed a stronger association with mobility limitations in children with CP than spasticity. Strength training for these children is, therefore, expected to improve or maintain their strength and functional performance.

Eligibility criteria: Inclusion Criteria:

* age between 7 years and 16 years;
* classified in levels I of the Gross Motor Function Classification System (GMFCS)
* able to follow and accept verbal instructions

Exclusion Criteria:

* any orthopaedic surgery or botulinum toxin injection in the past 6 months,
* children whose parents refused to participate

Primary outcomes:
measure: muscle strength
timeFrame: change from basaline muscle strenght of lower extremities at 12 weeks
Secondary outcomes:
measure: gross motor function
timeFrame: change from basaline gross motor funciton at 12 weeks
measure: muscle tone
timeFrame: change from basaline muscle tone at 12 weeks
measure: balance
timeFrame: change from basaline balance at 12 week
measure: functional muscle strength
timeFrame: change from basaline funcitonal muscle strenght at 12 weeks
measure: muscle performance
timeFrame: change from basaline muscle performance at 12 weeks
measure: power
timeFrame: change from basaline short-term muscle power at 12 weeks
measure: Agility
timeFrame: change from basaline agility at 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Ozgun Kaya Kara, PhD
role: STUDY_DIRECTOR
References:
citation: Park EY, Kim WH. Meta-analysis of the effect of strengthening interventions in individuals with cerebral palsy. Res Dev Disabil. 2014 Feb;35(2):239-49. doi: 10.1016/j.ridd.2013.10.021. Epub 2013 Nov 27.
citation: Taylor NF, Dodd KJ, Baker RJ, Willoughby K, Thomason P, Graham HK. Progressive resistance training and mobility-related function in young people with cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2013 Sep;55(9):806-12. doi: 10.1111/dmcn.12190. Epub 2013 Jun 22.
citation: Scholtes VA, Becher JG, Comuth A, Dekkers H, Van Dijk L, Dallmeijer AJ. Effectiveness of functional progressive resistance exercise strength training on muscle strength and mobility in children with cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2010 Jun;52(6):e107-13. doi: 10.1111/j.1469-8749.2009.03604.x. Epub 2010 Feb 12.
citation: Kaya Kara O, Atasavun Uysal S, Turker D, Karayazgan S, Gunel MK, Baltaci G. The effects of Kinesio Taping on body functions and activity in unilateral spastic cerebral palsy: a single-blind randomized controlled trial. Dev Med Child Neurol. 2015 Jan;57(1):81-8. doi: 10.1111/dmcn.12583. Epub 2014 Sep 12.