search
Back to results

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

Primary Purpose

Spastic Hemiplegic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
control group
intervention group
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Hemiplegic Cerebral Palsy focused on measuring cerebral palsy, mirror therapy, cerebral re-organization, upper extremity, daily life activities, functional motor capacity, motor functions

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

control group

intervention group

Arm Description

Children continued their traditional physiotherapy

We applied mirror therapy in addition to traditional physiotherapy

Outcomes

Primary Outcome Measures

Functional Magnetic Resonance Imaging (fMRI)
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
Quality of upper extremity skills assessment (QUEST)
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 Outcome Measures

Functional independence measure (WeeFIM)
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).
Child Health Questionnaire Parent Form 50 Questions (CHQ-PF50)
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

Full Information

First Posted
July 27, 2018
Last Updated
August 2, 2018
Sponsor
Hacettepe University
search

1. Study Identification

Unique Protocol Identification Number
NCT03612128
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 12, 2015 (Actual)
Primary Completion Date
December 19, 2016 (Actual)
Study Completion Date
March 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Hemiplegic Cerebral Palsy
Keywords
cerebral palsy, mirror therapy, cerebral re-organization, upper extremity, daily life activities, functional motor capacity, motor functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
Children continued their traditional physiotherapy
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
We applied mirror therapy in addition to traditional physiotherapy
Intervention Type
Other
Intervention Name(s)
control group
Other Intervention Name(s)
traditional physiotherapy
Intervention Description
Children continued their traditional physiotherapy including upper limb exercises in three times a week for 8 week.
Intervention Type
Other
Intervention Name(s)
intervention group
Other Intervention Name(s)
mirror therapy in addition to traditional physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Magnetic Resonance Imaging (fMRI)
Description
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
Time Frame
change from baseline brain reorganization at 8 weeks
Title
Quality of upper extremity skills assessment (QUEST)
Description
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.
Time Frame
change from baseline upper extremity skills at 8 weeks
Secondary Outcome Measure Information:
Title
Functional independence measure (WeeFIM)
Description
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).
Time Frame
change from baseline functional independence at 8 weeks
Title
Child Health Questionnaire Parent Form 50 Questions (CHQ-PF50)
Description
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
Time Frame
change from baseline quality of life at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duygu Korkem, PhD
Organizational Affiliation
Uskudar University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12578233
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. Erratum In: Dev Med Child Neurol. 2003 Mar;45(3):206.
Results Reference
background
PubMed Identifier
12227614
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.
Results Reference
background
PubMed Identifier
16467053
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.
Results Reference
background
PubMed Identifier
15315248
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.
Results Reference
background
PubMed Identifier
21410693
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs