Spastic Hemiplegic Cerebral PalsyNCT02458612
Effects of Mirror Therapy Combined With Progressive Strength Training in Unilateral Spastic Cerebral Palsy
A study testing intervention group in people with Spastic Hemiplegic Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effects of mirror therapy combined with upper extremity strengthening training on upper extremity function in children with unilateral spastic Cerebral Palsy (CP): a single blind randomized controlled trial. In the literature, there was no randomized controlled trial. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Spastic Hemiplegic Cerebral Palsy
- What is being tested?
- intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2016to Dec 2017
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age between 6 years and 18 years
- classified in levels I or II of the Gross Motor Function Classification System (GMFCS)
- classified in levels I, II-III of the Manual Ability Classification System (MACS)
- 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
- Epileptic seizures that can not be stopped
- Individuals who can not participate in any physical activities because of chronic disease except cerebral palsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mirror Therapy Combined With Progressive Strength Training on Upper Limb Function in Children With Unilateral Spastic Cerebral Palsy
The purpose of this study is to investigate the effects of mirror therapy combined with upper extremity strengthening training on upper extremity function in children with unilateral spastic Cerebral Palsy (CP): a single blind randomized controlled trial. In the literature, there was no randomized controlled trial. According to literature, there are few studies that investigate the effects of mirror therapy in children with CP. But there is no randomized controlled trial, explore the effects of mirror therapy combined with upper extremity strength training on upper extremity functions in unilateral spastic CP. Hypothesis of this study is that mirror therapy combined with strength training improves upper extremity function and muscle strength in unilateral spastic CP.
Read the detailed description
Cerebral Palsy (CP) is a permanent but not progressive disorder of motor function and movement/posture that caused by lesion in the immature brain. Children with hemiplegic CP have unilateral motor disorder affecting the right or left half of the body. They constitute 42% of all CP. motor impairment of the upper extremity usually occurs more than the lower extremity. This motor impairment of upper extremity is one of the main reasons of the muscle weakness in children with unilateral CP. Nowadays studies has been proven to increase the activity and the body structure and function without any negative effect of strengthening education in children with CP. Park \& Kim showed that huge impact of the upper and lower reinforcement training on children with CP the current meta-analysis (d = 0.861).
To improve upper extremity function in children with unilateral CP, the mirror therapy is a promising approach. Mirror therapy for the first time, Ramachandran et al. has described for the treatment of phantom pain in amputee. Also in unilateral spastic CP mirror therapy have indicated that visual illusion of functional limb provided by mirror can support healing. By means of visual feedback, modified vision and perception is stimulated plasticity the premotor cortex and developed reorganization. In the current studies, mirror therapy in hemiplegic patients, have been shown that improve the function and reduce the sensitivity of the hemi neglect. Gygax et al. have investigated the effects of mirror therapy on upper extremity function 10 children with unilateral spastic CP between 6-14 years. Consequently, the spontaneous use affected hand, the maximum grip force increase of 15% and is demonstrated that improve the upper extremity motor function.
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Being tested
- control group, intervention group
- Keywords
- cerebral palsy, mirror therapy, strength training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupOther
Also called traditional therapy
We will apply traditional physiotherapy including upper limb exercises in three times a week for 12 week.
intervention groupOther
Also called mirror therapy and progressive strength training
Participants allocated to the experimental group completed three times a week, 12-week mirror therapy combined with progressive strength training. This protocol consisted of mirror therapy with a mirror box, strength training with Thera-band and exercises for scapular dyskinesis. 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 | We will apply only upper limbs exercises with traditional therapy. Receives: Other: control group |
| intervention group | Active comparator | We will apply mirror therapy and progressive strength training for upper extremities. Receives: Other: intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper extremity skills
Quality of upper extremity skills assessment will be assessed by Quality of Upper Extremity Skills Test (QUEST). The test evaluates that handcraft and the quality of the movement in children with CP. It examines the quality of upper extremity skills in 5 sub-sections. It is used to between 18 monhts- 8 years age of children.
Measured: change from baseline upper extremity skills at 12 weeks
Secondary outcomes (2)
muscle tone
Children's muscle tone will be assessed by Modified Tardieu Scale (MTS). The original scale was developed in 1954 to assess spasticity by passive motion. This scale reveals the speed-dependent nature of spasticity. Passive stretching is made 3 different speeds that limb segment in the rate of fall with gravity and is faster than this speed and is slower than this speed. It has been developed by Boyd and Graham for 1999. Original scale is added to the assessment position of the limbs and angle of spasticity.
Measured: change from baseline muscle tone at 12 weeks
muscle strength
8 channels Biopac® MP150 surface electromyography for root mean square of maximum voluntary contraction, hand-held dynamometer "Power track II commander" for isometric muscle strength will be used to evaluate muscle strength.
Measured: change from baseline muscle stregth 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 posted1 Jun 2015 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spastic Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 30 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
- NCT02458612
- Sponsor's protocol ID
- GO 15/135-43
- Status last verified
- Feb 2020
- First submitted
- 28 May 2015
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gygax MJ, Schneider P, Newman CJ. Mirror therapy in children with hemiplegia: a pilot study. Dev Med Child Neurol. 2011 May;53(5):473-6. doi: 10.1111/j.1469-8749.2011.03924.x. Epub 2011 Mar 17.
PubMed 21410693Piraua AL, Pitangui AC, Silva JP, Pereira dos Passos MH, Alves de Oliveira VM, Batista Lda S, Cappato de Araujo R. Electromyographic analysis of the serratus anterior and trapezius muscles during push-ups on stable and unstable bases in subjects with scapular dyskinesis. J Electromyogr Kinesiol. 2014 Oct;24(5):675-81. doi: 10.1016/j.jelekin.2014.05.009. Epub 2014 Jun 12.
PubMed 24997890Rameckers EA, Janssen-Potten YJ, Essers IM, Smeets RJ. Efficacy of upper limb strengthening in children with Cerebral Palsy: A critical review. Res Dev Disabil. 2015 Jan;36C:87-101. doi: 10.1016/j.ridd.2014.09.024. Epub 2014 Oct 15.
PubMed 25462469
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mirror Therapy Combined With Progressive Strength Training on Upper Limb Function in Children With Unilateral Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02458612
- Acronym / sponsor ID
- GO 15/135-43
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Keywords
- cerebral palsy, mirror therapy, strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 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.
The purpose of this study is to investigate the effects of mirror therapy combined with upper extremity strengthening training on upper extremity function in children with unilateral spastic Cerebral Palsy (CP): a single blind randomized controlled trial. In the literature, there was no randomized controlled trial. According to literature, there are few studies that investigate the effects of mirror therapy in children with CP. But there is no randomized controlled trial, explore the effects of mirror therapy combined with upper extremity strength training on upper extremity functions in unilateral spastic CP. Hypothesis of this study is that mirror therapy combined with strength training improves upper extremity function and muscle strength in unilateral spastic CP.
Detailed description
Cerebral Palsy (CP) is a permanent but not progressive disorder of motor function and movement/posture that caused by lesion in the immature brain. Children with hemiplegic CP have unilateral motor disorder affecting the right or left half of the body. They constitute 42% of all CP. motor impairment of the upper extremity usually occurs more than the lower extremity. This motor impairment of upper extremity is one of the main reasons of the muscle weakness in children with unilateral CP. Nowadays studies has been proven to increase the activity and the body structure and function without any negative effect of strengthening education in children with CP. Park \& Kim showed that huge impact of the upper and lower reinforcement training on children with CP the current meta-analysis (d = 0.861).
To improve upper extremity function in children with unilateral CP, the mirror therapy is a promising approach. Mirror therapy for the first time, Ramachandran et al. has described for the treatment of phantom pain in amputee. Also in unilateral spastic CP mirror therapy have indicated that visual illusion of functional limb provided by mirror can support healing. By means of visual feedback, modified vision and perception is stimulated plasticity the premotor cortex and developed reorganization. In the current studies, mirror therapy in hemiplegic patients, have been shown that improve the function and reduce the sensitivity of the hemi neglect. Gygax et al. have investigated the effects of mirror therapy on upper extremity function 10 children with unilateral spastic CP between 6-14 years. Consequently, the spontaneous use affected hand, the maximum grip force increase of 15% and is demonstrated that improve the upper extremity motor function.
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: control groupWe will apply only upper limbs exercises with traditional therapy. |
| intervention group | Active comparator | Other: intervention groupWe will apply mirror therapy and progressive strength training for upper extremities. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age between 6 years and 18 years
- classified in levels I or II of the Gross Motor Function Classification System (GMFCS)
- classified in levels I, II-III of the Manual Ability Classification System (MACS)
- able to follow and accept verbal instructions.
Key exclusion criteria (4 listed)
- any orthopaedic surgery or botulinum toxin injection in the past 6 months,
- children whose parents refused to participate
- Epileptic seizures that can not be stopped
- Individuals who can not participate in any physical activities because of chronic disease except cerebral palsy.
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 |
|---|---|---|
| control groupAlso: traditional therapyWe will apply traditional physiotherapy including upper limb exercises in three times a week for 12 week. | Other | control group |
| intervention groupAlso: mirror therapy and progressive strength trainingParticipants allocated to the experimental group completed three times a week, 12-week mirror therapy combined with progressive strength training. This protocol consisted of mirror therapy with a mirror box, strength training with Thera-band and exercises for scapular dyskinesis. 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
upper extremity skills
Time frame: change from baseline upper extremity skills at 12 weeks
Quality of upper extremity skills assessment will be assessed by Quality of Upper Extremity Skills Test (QUEST). The test evaluates that handcraft and the quality of the movement in children with CP. It examines the quality of upper extremity skills in 5 sub-sections. It is used to between 18 monhts- 8 years age of children.
2 secondary outcomes
muscle tone
Time frame: change from baseline muscle tone at 12 weeks
muscle strength
Time frame: change from baseline muscle stregth 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 12 Feb 2020.
- Background: PubMed 21410693Gygax MJ, Schneider P, Newman CJ. Mirror therapy in children with hemiplegia: a pilot study. Dev Med Child Neurol. 2011 May;53(5):473-6. doi: 10.1111/j.1469-8749.2011.03924.x. Epub 2011 Mar 17.
- Background: PubMed 24997890Piraua AL, Pitangui AC, Silva JP, Pereira dos Passos MH, Alves de Oliveira VM, Batista Lda S, Cappato de Araujo R. Electromyographic analysis of the serratus anterior and trapezius muscles during push-ups on stable and unstable bases in subjects with scapular dyskinesis. J Electromyogr Kinesiol. 2014 Oct;24(5):675-81. doi: 10.1016/j.jelekin.2014.05.009. Epub 2014 Jun 12.
- Background: PubMed 25462469Rameckers EA, Janssen-Potten YJ, Essers IM, Smeets RJ. Efficacy of upper limb strengthening in children with Cerebral Palsy: A critical review. Res Dev Disabil. 2015 Jan;36C:87-101. doi: 10.1016/j.ridd.2014.09.024. Epub 2014 Oct 15.
- 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 intervention group 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 4 inclusion and 4 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 12 Feb 2020. 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?
upper extremity skills (time frame: change from baseline upper extremity skills 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 NCT02458612, which also lists 3 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 12 Feb 2020.