Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02458612
Other study ID # GO 15/135-43
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date December 2017

Study information

Verified date February 2020
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Pirauá AL, Pitangui AC, Silva JP, Pereira dos Passos MH, Alves de Oliveira VM, Batista Lda S, Cappato de Araújo 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. change from baseline muscle tone at 12 weeks
Secondary muscle strength 8 channels BiopacĀ® 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. change from baseline muscle stregth at 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT02460406 - Progressive Functional Strength Training in Unilateral Spastic Cerebral Palsy N/A
Completed NCT02010736 - Loading Gait in Spatic Cerebral Palsy N/A
Completed NCT04064788 - Modified Constraint-Induced Movement Therapy in Children With Hemiparetic Cerebral Palsy N/A
Completed NCT05593406 - Mechanical Vibration on Children With Cerebral Palsy N/A
Completed NCT04171232 - Effect of Augmented Reality Intervention on the Range of Motion, Muscle Strength, Function of Upper Extremity and Balance in Children With Spastic Hemiplegic Cerebral Palsy: A Randomized Clinical Trial N/A
Completed NCT04884386 - Effects of WALKBOT-G Robot-assisted Gait Training on Anticipatory Posture Adjustment Function and Balance With Cerebral Palsy N/A
Completed NCT05094921 - Halliwick Concept on Motor Functions in Spastic CP N/A
Completed NCT03612128 - The Effect of Mirror Therapy on Cerebral Re-organization, Functional Motor Skills, and Quality of Life in Hemiplegic Cerebral Palsy N/A
Recruiting NCT05261048 - Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance N/A
Completed NCT06352762 - The Effects of Upper Extremity Robotic Rehabilitation in Children With Spastic Hemiparetic Cerebral Palsy N/A
Recruiting NCT03402854 - tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy N/A
Completed NCT04154566 - Influence of Aerobic Exercise on Inhibitory Control of Excutive Function in Spastic Hemiplegic C.P N/A