- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02458612
Effects of Mirror Therapy Combined With Progressive Strength Training in Unilateral Spastic Cerebral Palsy
Effectiveness of Mirror Therapy Combined With Progressive Strength Training on Upper Limb Function in Children With Unilateral Spastic Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey, 06100
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: control group
We will apply only upper limbs exercises with traditional therapy.
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We will apply traditional physiotherapy including upper limb exercises in three times a week for 12 week.
Other Names:
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Active Comparator: intervention group
We will apply mirror therapy and progressive strength training for upper extremities.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
upper extremity skills
Time Frame: change from baseline upper extremity skills at 12 weeks
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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.
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change from baseline upper extremity skills at 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle tone
Time Frame: change from baseline muscle tone at 12 weeks
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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.
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change from baseline muscle tone at 12 weeks
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muscle strength
Time Frame: change from baseline muscle stregth at 12 weeks
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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.
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change from baseline muscle stregth at 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ozgun Kaya Kara, PhD, Hacettepe University
Publications and helpful links
General 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.
- Piraua 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.
- Rameckers 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 15/135-43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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