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Progressive Functional Strength Training in Unilateral Spastic Cerebral Palsy

Primary Purpose

Spastic Hemiplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
traditional physiotherapy
progressive functional strength training
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Hemiplegic Cerebral Palsy focused on measuring strength training, virtual reality, plyometric exercises, cerebral palsy, hemiplegic

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

control group

intervention group

Arm Description

traditional physiotherapy (stretching, normal range of movement, walking)

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.

Outcomes

Primary Outcome Measures

muscle strength
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

gross motor function
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.
muscle tone
modified Tardieu scale was used to evaluate muscle tone.
balance
Dynamic balance was assessed with Time up & go and functional reaching test.
functional muscle strength
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.
muscle performance
Standing Broad Jump and vertical jump was used to evaluate muscle performance.
power
Short-term muscle power was evaluated using the mean power and peak power obtained from the Muscle Power Sprint Test.
Agility
Agility was measured via using the 10x5m sprint test.

Full Information

First Posted
May 28, 2015
Last Updated
May 20, 2016
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT02460406
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Hemiplegic Cerebral Palsy
Keywords
strength training, virtual reality, plyometric exercises, cerebral palsy, hemiplegic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
traditional physiotherapy (stretching, normal range of movement, walking)
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
traditional physiotherapy
Intervention Description
We are applying routine traditional physiotherapy consisted of neurodevelopmental treatment (stretching, weight bearing, functional reaching & walking so on).
Intervention Type
Other
Intervention Name(s)
progressive functional strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
muscle strength
Description
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.
Time Frame
change from basaline muscle strenght of lower extremities at 12 weeks
Secondary Outcome Measure Information:
Title
gross motor function
Description
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.
Time Frame
change from basaline gross motor funciton at 12 weeks
Title
muscle tone
Description
modified Tardieu scale was used to evaluate muscle tone.
Time Frame
change from basaline muscle tone at 12 weeks
Title
balance
Description
Dynamic balance was assessed with Time up & go and functional reaching test.
Time Frame
change from basaline balance at 12 week
Title
functional muscle strength
Description
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.
Time Frame
change from basaline funcitonal muscle strenght at 12 weeks
Title
muscle performance
Description
Standing Broad Jump and vertical jump was used to evaluate muscle performance.
Time Frame
change from basaline muscle performance at 12 weeks
Title
power
Description
Short-term muscle power was evaluated using the mean power and peak power obtained from the Muscle Power Sprint Test.
Time Frame
change from basaline short-term muscle power at 12 weeks
Title
Agility
Description
Agility was measured via using the 10x5m sprint test.
Time Frame
change from basaline agility at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozgun Kaya Kara, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24291625
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.
Results Reference
background
PubMed Identifier
23789741
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.
Results Reference
background
PubMed Identifier
20132136
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.
Results Reference
background
PubMed Identifier
25213082
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.
Results Reference
background
Links:
URL
http://www.nsca.com/
Description
National Strength and Conditioning Association

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Progressive Functional Strength Training in Unilateral Spastic Cerebral Palsy

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