Progressive Functional Strength Training in Unilateral Spastic Cerebral Palsy

• ClinicalTrials.gov Identifier: NCT02460406
• Recruitment Status: Completed
• First Posted: June 2, 2015
• Last Update Posted: May 23, 2016
• Sponsor: Hacettepe University
• Information provided by (Responsible Party): Ozgun Kaya Kara, Hacettepe University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spastic Hemiplegic Cerebral Palsy	Other: traditional physiotherapy; Other: progressive functional strength training	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: September 2014
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
control group; traditional physiotherapy (stretching, normal range of movement, walking)	Other: traditional physiotherapy; We are applying routine traditional physiotherapy consisted of neurodevelopmental treatment (stretching, weight bearing, functional reaching & walking so on).
Active Comparator: intervention group; progressive functional strength training protocol on lower extremities consisted of functional squat system with virtual reality in leg press, plyometric exercises, exercises with Bosu ball & heel-rise exercises.	Other: progressive functional strength training; Participants allocated to the experimental group completed three times a week, 12-week progressive resistance training protocol. This protocol consisted of functional squat system with virtual reality in leg press, plyometric exercises, exercises with Bosu ball & heel-rise exercises. This intensity of training is approximately equal to training at an intensity of 60% to 80% of one-repetition maximum according to "National Strength and Conditioning Association (NSCA)" protocols. Intensity of exercise is gradually increased 10% bi-weekly.

Outcome Measures

Primary Outcome Measures :

1. muscle strength [ Time Frame: change from basaline muscle strenght of lower extremities at 12 weeks ]
   8 channels Biopac® surface electromyography data acquisition and analysis systems for root mean square of maximum voluntary contraction, hand-held dynamometer "Power track II commander" for isometric muscle strength and functional squat rehabilitation system with leg press for one-maximum repetition was used to evaluate muscle strength.

Secondary Outcome Measures :

1. gross motor function [ Time Frame: change from basaline gross motor funciton at 12 weeks ]
   Gross motor function will be assessed using dimensions D and E of the Gross Motor Function Measurement (GMFM), which consists of standing, and walking, running, and jumping. 10-metre walking and 1-minute walking will be evaluated function.
2. muscle tone [ Time Frame: change from basaline muscle tone at 12 weeks ]
   modified Tardieu scale was used to evaluate muscle tone.
3. balance [ Time Frame: change from basaline balance at 12 week ]
   Dynamic balance was assessed with Time up & go and functional reaching test.
4. functional muscle strength [ Time Frame: change from basaline funcitonal muscle strenght at 12 weeks ]
   The 30s Repetition Maximum test was used to assess functional muscle strength of the lower extremities. The three closed kinetic chain exercises of lateral step-up test, sit to stand, and attain stand through half knee were used.
5. muscle performance [ Time Frame: change from basaline muscle performance at 12 weeks ]
   Standing Broad Jump and vertical jump was used to evaluate muscle performance.
6. power [ Time Frame: change from basaline short-term muscle power at 12 weeks ]
   Short-term muscle power was evaluated using the mean power and peak power obtained from the Muscle Power Sprint Test.
7. Agility [ Time Frame: change from basaline agility at 12 weeks ]
   Agility was measured via using the 10x5m sprint test.

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

Hacettepe University

Ankara, Turkey, 06100

Sponsors and Collaborators

Hacettepe University

Investigators

• Study Director: Ozgun Kaya Kara, PhD; Hacettepe University

More Information

Additional Information:

National Strength and Conditioning Association 

Publications:

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.

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.

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.

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.

• Responsible Party: Ozgun Kaya Kara, PT, PhD, Hacettepe University
• ClinicalTrials.gov Identifier: NCT02460406
• Other Study ID Numbers: GO 14/224
• First Posted: June 2, 2015
• Last Update Posted: May 23, 2016
• Last Verified: May 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Ozgun Kaya Kara, Hacettepe University:

strength training; virtual reality; plyometric exercises; cerebral palsy; hemiplegic

Additional relevant MeSH terms:

Muscle Spasticity; Paralysis; Cerebral Palsy; Neurologic Manifestations; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations