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Effects of Mirror Therapy Combined With Progressive Strength Training in Unilateral Spastic 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, strength training

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

We will apply only upper limbs exercises with traditional therapy.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

muscle tone
Children's muscle tone will be assessed by Modified Tardieu Scale (MTS). The original scale was developed in 1954 to assess spasticity by passive motion. This scale reveals the speed-dependent nature of spasticity. Passive stretching is made 3 different speeds that limb segment in the rate of fall with gravity and is faster than this speed and is slower than this speed. It has been developed by Boyd and Graham for 1999. Original scale is added to the assessment position of the limbs and angle of spasticity.
muscle strength
8 channels Biopac® MP150 surface electromyography for root mean square of maximum voluntary contraction, hand-held dynamometer "Power track II commander" for isometric muscle strength will be used to evaluate muscle strength.

Full Information

First Posted
May 28, 2015
Last Updated
February 11, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT02458612
Brief Title
Effects of Mirror Therapy Combined With Progressive Strength Training in Unilateral Spastic Cerebral Palsy
Official Title
Effectiveness of Mirror Therapy Combined With Progressive Strength Training on Upper Limb Function in Children With Unilateral Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Cerebral Palsy (CP) is a permanent but not progressive disorder of motor function and movement/posture that caused by lesion in the immature brain. Children with hemiplegic CP have unilateral motor disorder affecting the right or left half of the body. They constitute 42% of all CP. motor impairment of the upper extremity usually occurs more than the lower extremity. This motor impairment of upper extremity is one of the main reasons of the muscle weakness in children with unilateral CP. Nowadays studies has been proven to increase the activity and the body structure and function without any negative effect of strengthening education in children with CP. Park & Kim showed that huge impact of the upper and lower reinforcement training on children with CP the current meta-analysis (d = 0.861). 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 reorganization. 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, strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
We will apply only upper limbs exercises with traditional therapy.
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
We will apply mirror therapy and progressive strength training for upper extremities.
Intervention Type
Other
Intervention Name(s)
control group
Other Intervention Name(s)
traditional therapy
Intervention Description
We will apply traditional physiotherapy including upper limb exercises in three times a week for 12 week.
Intervention Type
Other
Intervention Name(s)
intervention group
Other Intervention Name(s)
mirror therapy and progressive strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
upper extremity skills
Description
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.
Time Frame
change from baseline upper extremity skills at 12 weeks
Secondary Outcome Measure Information:
Title
muscle tone
Description
Children's muscle tone will be assessed by Modified Tardieu Scale (MTS). The original scale was developed in 1954 to assess spasticity by passive motion. This scale reveals the speed-dependent nature of spasticity. Passive stretching is made 3 different speeds that limb segment in the rate of fall with gravity and is faster than this speed and is slower than this speed. It has been developed by Boyd and Graham for 1999. Original scale is added to the assessment position of the limbs and angle of spasticity.
Time Frame
change from baseline muscle tone at 12 weeks
Title
muscle strength
Description
8 channels Biopac® MP150 surface electromyography for root mean square of maximum voluntary contraction, hand-held dynamometer "Power track II commander" for isometric muscle strength will be used to evaluate muscle strength.
Time Frame
change from baseline muscle stregth at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozgun Kaya Kara, PhD
Organizational Affiliation
Hacettepe 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
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
PubMed Identifier
24997890
Citation
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.
Results Reference
background
PubMed Identifier
25462469
Citation
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.
Results Reference
background

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Effects of Mirror Therapy Combined With Progressive Strength Training in Unilateral Spastic Cerebral Palsy

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