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Trial record 51 of 10339 for:    strength

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

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ClinicalTrials.gov Identifier: NCT02458612
Recruitment Status : Unknown
Verified September 2015 by Ozgun Kaya Kara, Hacettepe University.
Recruitment status was:  Not yet recruiting
First Posted : June 1, 2015
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
Ozgun Kaya Kara, Hacettepe University

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.

Condition or disease Intervention/treatment Phase
Spastic Hemiplegic Cerebral Palsy Other: control group Other: intervention group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Mirror Therapy Combined With Progressive Strength Training on Upper Limb Function in Children With Unilateral Spastic Cerebral Palsy
Study Start Date : June 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
control group
We will apply only upper limbs exercises with traditional therapy.
Other: control group
We will apply traditional physiotherapy including upper limb exercises in three times a week for 12 week.
Other Name: traditional therapy

Active Comparator: intervention group
We will apply mirror therapy and progressive strength training for upper extremities.
Other: intervention 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.
Other Name: mirror therapy and progressive strength training




Primary Outcome Measures :
  1. upper extremity skills [ Time Frame: change from baseline upper extremity skills at 12 weeks ]
    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 :
  1. muscle tone [ Time Frame: change from baseline muscle tone at 12 weeks ]
    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.

  2. muscle strength [ Time Frame: change from baseline muscle stregth at 12 weeks ]
    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.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458612


Contacts
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Contact: Ozgun Kaya Kara, PhD 00905309342163 ozgun_kaya@yahoo.com
Contact: Bilge Nur Yardimci, PT 00905052237114 bilgenuryardimci@gmail.com

Locations
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Turkey
Hacettepe University
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Study Director: Ozgun Kaya Kara, PhD Hacettepe University

Publications:
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Responsible Party: Ozgun Kaya Kara, PT, PhD, Hacettepe University
ClinicalTrials.gov Identifier: NCT02458612     History of Changes
Other Study ID Numbers: GO 15/135-43
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: September 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ozgun Kaya Kara, Hacettepe University:
cerebral palsy
mirror therapy
strength training
Additional relevant MeSH terms:
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Muscle Spasticity
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations