Spastic Hemiplegic Cerebral PalsyNCT02460406
Progressive Functional Strength Training in Unilateral Spastic Cerebral Palsy
A study testing traditional physiotherapy and progressive functional strength training in people with Spastic Hemiplegic Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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)… Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Spastic Hemiplegic Cerebral Palsy
- What is being tested?
- traditional physiotherapy and progressive functional strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- any orthopaedic surgery or botulinum toxin injection in the past 6 months,
- children whose parents refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Being tested
- traditional physiotherapy, progressive functional strength training
- Keywords
- strength training, virtual reality, plyometric exercises, cerebral palsy, hemiplegic
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional physiotherapyOther
We are applying routine traditional physiotherapy consisted of neurodevelopmental treatment (stretching, weight bearing, functional reaching \& walking so on).
progressive functional strength trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | traditional physiotherapy (stretching, normal range of movement, walking) Receives: Other: traditional physiotherapy |
| intervention group | Active comparator | 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. Receives: Other: progressive functional strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from basaline muscle strenght of lower extremities at 12 weeks
Secondary outcomes (7)
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.
Measured: change from basaline gross motor funciton at 12 weeks
muscle tone
modified Tardieu scale was used to evaluate muscle tone.
Measured: change from basaline muscle tone at 12 weeks
balance
Dynamic balance was assessed with Time up \& go and functional reaching test.
Measured: change from basaline balance at 12 week
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.
Measured: change from basaline funcitonal muscle strenght at 12 weeks
muscle performance
Standing Broad Jump and vertical jump was used to evaluate muscle performance.
Measured: change from basaline muscle performance at 12 weeks
power
Short-term muscle power was evaluated using the mean power and peak power obtained from the Muscle Power Sprint Test.
Measured: change from basaline short-term muscle power at 12 weeks
Agility
Agility was measured via using the 10x5m sprint test.
Measured: change from basaline agility at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spastic Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Hacettepe University
- Investigators
- Ozgun Kaya Kara, PhD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460406
- Sponsor's protocol ID
- GO 14/224
- Status last verified
- May 2016
- First submitted
- 28 May 2015
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 24291625Taylor 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.
PubMed 23789741Scholtes 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.
PubMed 20132136Kaya 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.
PubMed 25213082
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02460406
- Acronym / sponsor ID
- GO 14/224
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Keywords
- strength training, virtual reality, plyometric exercises, cerebral palsy, hemiplegic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: traditional physiotherapytraditional physiotherapy (stretching, normal range of movement, walking) |
| intervention group | Active comparator | Other: progressive functional strength trainingprogressive 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. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- any orthopaedic surgery or botulinum toxin injection in the past 6 months,
- children whose parents refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional physiotherapyWe are applying routine traditional physiotherapy consisted of neurodevelopmental treatment (stretching, weight bearing, functional reaching \& walking so on). | Other | control group |
| progressive functional strength trainingParticipants 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. | Other | intervention group |
Primary outcome
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.
7 secondary outcomes
gross motor function
Time frame: change from basaline gross motor funciton at 12 weeks
muscle tone
Time frame: change from basaline muscle tone at 12 weeks
balance
Time frame: change from basaline balance at 12 week
functional muscle strength
Time frame: change from basaline funcitonal muscle strenght at 12 weeks
muscle performance
Time frame: change from basaline muscle performance at 12 weeks
power
Time frame: change from basaline short-term muscle power at 12 weeks
Agility
Time frame: change from basaline agility at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Background: PubMed 24291625Park 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.
- Background: PubMed 23789741Taylor 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.
- Background: PubMed 20132136Scholtes 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.
- Background: PubMed 25213082Kaya 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.
- National Strength and Conditioning AssociationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozgun Kaya Kara, PhD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional physiotherapy and progressive functional strength training in people with Spastic Hemiplegic Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (time frame: change from basaline muscle strenght of lower extremities at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02460406, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.