Clinical trial NCT03612128: The Effect of Mirror Therapy on Cerebral Re-organization, Functional Motor Skills, and Quality of Life in Hemiplegic Cerebral Palsy
Official title: The Effect of Upper Extremity Mirror Therapy on Cerebral Re-organization, Functional Motor Skills, Daily Life Activities and Health Related Quality of Life in Children With Spastic Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Hemiplegic Cerebral Palsy
Keywords: cerebral palsy
mirror therapy
cerebral re-organization
upper extremity
daily life activities
functional motor capacity
motor functions
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 10
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this type of controlled clinical trials, the same subjects are used as experimental and control groups, ie both the new treatment method and the classical method or the placebo method are applied to the same subjects. The efficacy is applied to the new treatment method and on the other hand the classical method is applied on the same subjects at different times and the results are compared.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate brain reorganization, functional motor development, level of daily living activity and quality of life of upper extremity mirror therapy in children with spastic hemiplegic cerebral palsy. Several studies have reported increased use of the affected arm following rearrangement of cerebral re-organization with mirror therapy. The investigator's study is the first of its kind and was planned to evaluate the effectiveness of upper extremity mirror therapy in cerebral reorganization and functional motor skills in children with spastic hemiplegic cerebral palsy. Hypothesis of this study is that mirror therapy improves brain re-organisation, functional motor skills and daily living activities in unilateral spastic CP.

Detailed description: Cerebral palsy (CP) is the most common neurodisability in children. It has been defined as a disorder of movement and posture due to a defect or lesion of the immature brain and as a group of non-progressive, but often changing motor impairment syndromes secondary to lesions or anomalies of the brain arising in the early stages of development.

Characteristically, children with unilateral cerebral palsy (CP) have one well-functioning hand and one impaired hand.Common features of the hemiplegic hand are slowness, abnormal muscle tone, decreased strength, and coordination difficulties, which occur to a varying extent in children independently of age. Many children also have impaired sensibility and mirror movements. Perhaps most importantly, children with unilateral CP hav e varying degrees of limitation in their ability to handle objects in daily life. This limitation is most obvious insituations where two hands are needed. However, knowledge about bimanual ability in chil dren with unilateral CP and its development over time is scarce at present.

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 re-organization. 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.

Eligibility criteria: Inclusion Criteria:

* Congenital spastic hemiplegic cerebral palsy,
* Between the ages of 4-18,
* Continuing physiotherapy and rehabilitation program throughout the study.

Exclusion Criteria:

* Upper extremity fracture or muscle-tendon and bone operation shortly before 6 months,
* Any pharmacologic agent that will inhibit spasticity within 6 months,
* Visual function disorder except eye fracture defect

Primary outcomes:
measure: Functional Magnetic Resonance Imaging (fMRI)
timeFrame: change from baseline brain reorganization at 8 weeks
measure: Quality of upper extremity skills assessment (QUEST)
timeFrame: change from baseline upper extremity skills at 8 weeks
Secondary outcomes:
measure: Functional independence measure (WeeFIM)
timeFrame: change from baseline functional independence at 8 weeks
measure: Child Health Questionnaire Parent Form 50 Questions (CHQ-PF50)
timeFrame: change from baseline quality of life at 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Uskudar University
name: Duygu Korkem, PhD
role: STUDY_DIRECTOR
References:
citation: Fedrizzi E, Pagliano E, Andreucci E, Oleari G. Hand function in children with hemiplegic cerebral palsy: prospective follow-up and functional outcome in adolescence. Dev Med Child Neurol. 2003 Feb;45(2):85-91.
citation: Siebes RC, Wijnroks L, Vermeer A. Qualitative analysis of therapeutic motor intervention programmes for children with cerebral palsy: an update. Dev Med Child Neurol. 2002 Sep;44(9):593-603. doi: 10.1017/s0012162201002638.
citation: Odding E, Roebroeck ME, Stam HJ. The epidemiology of cerebral palsy: incidence, impairments and risk factors. Disabil Rehabil. 2006 Feb 28;28(4):183-91. doi: 10.1080/09638280500158422.
citation: Skold A, Josephsson S, Eliasson AC. Performing bimanual activities: the experiences of young persons with hemiplegic cerebral palsy. Am J Occup Ther. 2004 Jul-Aug;58(4):416-25. doi: 10.5014/ajot.58.4.416.
citation: 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.