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Effects of Mirror Neurons Stimulation on Motor Skill Rehabilitation in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT01267929
Recruitment Status : Completed
First Posted : December 29, 2010
Results First Posted : February 17, 2014
Last Update Posted : December 18, 2017
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Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study aimed to develop Video Compact Disc (VCD) program that applying the concept of imitative learning with mirror neurons stimulation on standard rehabilitation technique in children with cerebral palsy. The author will also examine effectiveness of the program by compare the motor function measured by the gross motor function measure (GMFM-66) between conventional physical therapy and the mirror neurons stimulation based VCD program for six months.

Condition or disease Intervention/treatment
Children With Spastic Diplegia, Between the Ages of 2 to 10 Years Gross Motor Function Classification System (GMFCS) Level I,II and III Procedure: The mirror neurons stimulation based VCD program Procedure: The conventional physical therapy

Detailed Description:
A randomized controlled trial was performed with thirty children with cerebral palsy recruited from Thammasat University Hospital and Rajanukul institute. Informed consent was obtained from the participants' parents before participation in this study. The participants were randomly assigned according to the randomization list to receive either the mirror neurons stimulation based VCD program and practice at home or conventional physical therapy for six months. The participants in the experiment group received the mirror neurons stimulation based VCD program and practice at home three times a day for six months. Concerning the control group, the participants received conventional physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. Both experimental and control groups were measured their motor functions with gross motor function measure (GMFM-66).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2009
Primary Completion Date : August 2011
Study Completion Date : October 2011

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Arms and Interventions

Arm Intervention/treatment
Experimental: The mirror neurons stimulation based VCD program
The children receive the mirror neurons stimulation based VCD program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
Procedure: The mirror neurons stimulation based VCD program
The children receive the mirror neurons stimulation based VCD program and practice at home three times a day for six months.
Active Comparator: The conventional physical therapy
The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
Procedure: The conventional physical therapy
The children were randomly assigned to receive the conventional physical therapy for six months. Both experimental and control groups were measured their motor functions with GMFM-66 by an independent pediatric physical therapist who was blinded for treatment allocation at entry, the second month and the sixth month.


Outcome Measures

Primary Outcome Measures :
  1. The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month. [ Time Frame: Base line, two months and six months ]
    The mean total score of GMFM-66 of each group at entry, the second and the sixth month. The GMFM-66 contains five dimensions of motor measure including lying/rolling (4 items), sitting (15 items), crawling/kneeling (10 items), standing (13 items), and walking/running/jumping (24 items). The GMFM-66 are scored on a 4-point ordinal scale 0=does not initiate, 1=initiates < 10% of activity,2=partially completes 10% to < 100% of activity,3=completes activity). The scores were converted to a continuous scale by using the Winsteps Rasch Software.The GMFM-66 score is an interval-level measure of function where subjects are placed on an ability continuum ranging from 0 (low motor ability) to 100 (high motor ability). GMFM-66 score less than 30 that are considered low gross motor skills.


Eligibility Criteria

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with cerebral palsy aged between 2-10 years old
  • GMFCS level of one to three
  • Able to verbal instruction
  • Sitting are performed without assistance
  • Standing and walking are performed with adult assistance
  • No severe limitation of joint movement

Exclusion Criteria:

  • The children were received orthopedic intervention or botulinum toxin injection within 6 months
  • Seizure
  • Other conditions that prevent children from participate in research project
  • Severe visual and hearing deficits
Contacts and Locations

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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): NCT01267929


Locations
Thailand
Department of Physical therapy, Faculty of Allied Health Sciences Thammasat University
Pathumthani, Thailand, 12120
Sponsors and Collaborators
Thammasat University
National Research Council of Thailand
Investigators
Study Director: Assoc.Prof.Paskorn Sritipsukho, MD Thailand:Faculty of Medicine Thammasat University
More Information

Responsible Party: Namfon Mahasup, Ph.D.candidate, Postgraduate Studied Program, faculty of Medicine, Thammasat University, Thammasat University
ClinicalTrials.gov Identifier: NCT01267929     History of Changes
Other Study ID Numbers: MTU-P-1-71/51
First Posted: December 29, 2010    Key Record Dates
Results First Posted: February 17, 2014
Last Update Posted: December 18, 2017
Last Verified: November 2017

Keywords provided by Namfon Mahasup, Thammasat University:
Children with cerebral palsy
Gross Motor Function Measure
Imitative learning
Mirror neuron
Action observation
Conventional physical therapy

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases