NCT02458612

Brief Summary

The purpose of this study is to investigate the effects of mirror therapy combined with upper extremity strengthening training on upper extremity function in children with unilateral spastic Cerebral Palsy (CP): a single blind randomized controlled trial. In the literature, there was no randomized controlled trial. According to literature, there are few studies that investigate the effects of mirror therapy in children with CP. But there is no randomized controlled trial, explore the effects of mirror therapy combined with upper extremity strength training on upper extremity functions in unilateral spastic CP. Hypothesis of this study is that mirror therapy combined with strength training improves upper extremity function and muscle strength in unilateral spastic CP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

May 28, 2015

Last Update Submit

February 11, 2020

Conditions

Keywords

cerebral palsymirror therapystrength training

Outcome Measures

Primary Outcomes (1)

  • upper extremity skills

    Quality of upper extremity skills assessment will 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. It examines the quality of upper extremity skills in 5 sub-sections. It is used to between 18 monhts- 8 years age of children.

    change from baseline upper extremity skills at 12 weeks

Secondary Outcomes (2)

  • muscle tone

    change from baseline muscle tone at 12 weeks

  • muscle strength

    change from baseline muscle stregth at 12 weeks

Study Arms (2)

control group

OTHER

We will apply only upper limbs exercises with traditional therapy.

Other: control group

intervention group

ACTIVE COMPARATOR

We will apply mirror therapy and progressive strength training for upper extremities.

Other: intervention group

Interventions

We will apply traditional physiotherapy including upper limb exercises in three times a week for 12 week.

Also known as: traditional therapy
control group

Participants allocated to the experimental group completed three times a week, 12-week mirror therapy combined with progressive strength training. This protocol consisted of mirror therapy with a mirror box, strength training with Thera-band and exercises for scapular dyskinesis. This intensity of training is approximately equal to training at an intensity of 60% to 80% of one-repetition maximum according to "National Strength and Conditioning Association (NSCA)" protocols. Intensity of exercise is gradually increased 10% bi-weekly.

Also known as: mirror therapy and progressive strength training
intervention group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age between 6 years and 18 years
  • classified in levels I or II of the Gross Motor Function Classification System (GMFCS)
  • classified in levels I, II-III of the Manual Ability Classification System (MACS)
  • able to follow and accept verbal instructions.

You may not qualify if:

  • any orthopaedic surgery or botulinum toxin injection in the past 6 months,
  • children whose parents refused to participate
  • Epileptic seizures that can not be stopped
  • Individuals who can not participate in any physical activities because of chronic disease except cerebral palsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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
  • Piraua AL, Pitangui AC, Silva JP, Pereira dos Passos MH, Alves de Oliveira VM, Batista Lda S, Cappato de Araujo R. Electromyographic analysis of the serratus anterior and trapezius muscles during push-ups on stable and unstable bases in subjects with scapular dyskinesis. J Electromyogr Kinesiol. 2014 Oct;24(5):675-81. doi: 10.1016/j.jelekin.2014.05.009. Epub 2014 Jun 12.

    PMID: 24997890BACKGROUND
  • Rameckers EA, Janssen-Potten YJ, Essers IM, Smeets RJ. Efficacy of upper limb strengthening in children with Cerebral Palsy: A critical review. Res Dev Disabil. 2015 Jan;36C:87-101. doi: 10.1016/j.ridd.2014.09.024. Epub 2014 Oct 15.

    PMID: 25462469BACKGROUND

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

  • Ozgun Kaya Kara, PhD

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 1, 2015

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2017

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations