NCT03612128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

July 27, 2018

Last Update Submit

August 2, 2018

Conditions

Keywords

cerebral palsymirror therapycerebral re-organizationupper extremitydaily life activitiesfunctional motor capacitymotor functions

Outcome Measures

Primary Outcomes (2)

  • 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

    change from baseline brain reorganization at 8 weeks

  • 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.

    change from baseline upper extremity skills at 8 weeks

Secondary Outcomes (2)

  • Functional independence measure (WeeFIM)

    change from baseline functional independence at 8 weeks

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

    change from baseline quality of life at 8 weeks

Study Arms (2)

control group

OTHER

Children continued their traditional physiotherapy

Other: control group

intervention group

ACTIVE COMPARATOR

We applied mirror therapy in addition to traditional physiotherapy

Other: intervention group

Interventions

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

Also known as: traditional physiotherapy
control 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.

Also known as: mirror therapy in addition to traditional physiotherapy
intervention group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 12578233BACKGROUND
  • 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.

    PMID: 12227614BACKGROUND
  • 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.

    PMID: 16467053BACKGROUND
  • 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.

    PMID: 15315248BACKGROUND
  • 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.

    PMID: 21410693BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Control GroupsMirror Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsPhysical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Duygu Korkem, PhD

    Uskudar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 2, 2018

Study Start

January 12, 2015

Primary Completion

December 19, 2016

Study Completion

March 13, 2017

Last Updated

August 3, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations