Progressive Functional Strength Training in Unilateral Spastic Cerebral Palsy
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
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 28, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedMay 23, 2016
May 1, 2016
7 months
May 28, 2015
May 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
change from basaline muscle strenght of lower extremities at 12 weeks
Secondary Outcomes (7)
gross motor function
change from basaline gross motor funciton at 12 weeks
muscle tone
change from basaline muscle tone at 12 weeks
balance
change from basaline balance at 12 week
functional muscle strength
change from basaline funcitonal muscle strenght at 12 weeks
muscle performance
change from basaline muscle performance at 12 weeks
- +2 more secondary outcomes
Study Arms (2)
control group
OTHERtraditional physiotherapy (stretching, normal range of movement, walking)
intervention group
ACTIVE COMPARATORprogressive 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.
Interventions
We are applying routine traditional physiotherapy consisted of neurodevelopmental treatment (stretching, weight bearing, functional reaching \& walking so on).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- any orthopaedic surgery or botulinum toxin injection in the past 6 months,
- children whose parents refused to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University
Ankara, 06100, Turkey (Türkiye)
Related Publications (4)
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.
PMID: 24291625BACKGROUNDTaylor 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.
PMID: 23789741BACKGROUNDScholtes 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.
PMID: 20132136BACKGROUNDKaya 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.
PMID: 25213082BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ozgun Kaya Kara, PhD
Hacettepe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PT, PhD
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 2, 2015
Study Start
September 1, 2014
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
May 23, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share