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

August 2, 2018 updated by: Duygu Korkem, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: control group
Children continued their traditional physiotherapy
Other: control group
Children continued their traditional physiotherapy including upper limb exercises in three times a week for 8 week.
Other Names:
  • traditional physiotherapy
ACTIVE_COMPARATOR: intervention group
We applied mirror therapy in addition to traditional physiotherapy
Other: intervention group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline brain reorganization at 8 weeks
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.
change from baseline upper extremity skills at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
change from baseline functional independence at 8 weeks
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
change from baseline quality of life at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Director: Duygu Korkem, PhD, Uskudar university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 12, 2015

Primary Completion (ACTUAL)

December 19, 2016

Study Completion (ACTUAL)

March 13, 2017

Study Registration Dates

First Submitted

July 27, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (ACTUAL)

August 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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