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Completed

NCT Number: NCT03612128

The Effect of Mirror Therapy on Cerebral Re-organization, Functional Motor Skills, and Quality of Life in Hemiplegic Cerebral Palsy

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.

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Key information

Conditions

Spastic Hemiplegic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Group

Other

Children continued their traditional physiotherapy including upper limb exercises in three times a week for 8 week.

Other names: traditional physiotherapy

Intervention group

Other

Participants allocated to the experimental group completed three times a week, 8-week mirror therapy in addition to traditional physiotherapy . This protocol consisted of mirror therapy with a mirror box.

Other names: mirror therapy in addition to traditional physiotherapy

Primary outcomes

  1. Functional Magnetic Resonance Imaging (fMRI)

    Time frame: change from baseline brain reorganization at 8 weeks

    Brain reorganization was assessed by functional magnetic resonance imaging (fMRI).Being a non-invasive method, FMRI is nowadays the most common method used to map the neural activity of the human brain. fMRI is also used to describe patterns of cortical activation in children and adults with brain lesions

  2. Quality of upper extremity skills assessment (QUEST)

    Time frame: change from baseline upper extremity skills at 8 weeks

    Quality of upper extremity skills assessment was 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.This is an objective standardized measure evaluating the quality of upper extremity function in 4 domains: dissociated movement, grasp, protective extension, and weight bearing. Scores for the QUEST are calculated as percentages with a maximum score of 100.

Secondary outcomes

  1. Functional independence measure (WeeFIM)

    Time frame: change from baseline functional independence at 8 weeks

    The functional independence assessment was be assessed by Functional Independence Measure (WeeFIM). The Weefim was designed as a basic indicator of severity of disability and to determine the amount of assistance required by children to perform daily living activities on a consistent basisThe subsets are categorized as self-care (six items), sphincter control (two items),transfers (three items), locomotion (two items), communication (two items), and social cognition (three items). Each measurement item of the subsets is scored on a scale of 1- 7, where 1 indicates total assistance and 7 shows complete independence. The minimum total score is 18 (total dependence in all skills) and the maximum score is 126 (complete independence in all skills).

  2. Child Health Questionnaire Parent Form 50 Questions (CHQ-PF50)

    Time frame: change from baseline quality of life at 8 weeks

    Health related quality of life was evaluated by the Child Health Questionnaire Parent Form 50 Questions (CHQ-PF50). 50-item parent-completed CHQ (CHQ-PF50), which measures 11 domains of health. Physical domains include the following: physical functioning, role/social limitations as a result of physicalhealth, bodily pain/discomfort, and general health perception.

    Psychosocial domains include the following: role/social limitations as a result of emotional-behavioral problems, self-esteem, mental health, general behavior, emotional impact on parent, and time impact on parents. A separate domain measures limitations in family activities. There is also a single-item measure of family cohesion. Scores for the domains and single item range from 0 to 100, with higher scores indicating better HRQL

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 2, 2018
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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