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

This study has been completed.
Sponsor:
Collaborator:
National Research Council of Thailand
Information provided by (Responsible Party):
Namfon Mahasup, Thammasat University
ClinicalTrials.gov Identifier:
NCT01267929
First received: December 28, 2010
Last updated: February 15, 2014
Last verified: February 2014
Results First Received: March 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Children With Spastic Diplegia Aged Between 2-10 Years.
Gross Motor Function Classification System (GMFCS) Level of 1-3.
Interventions: Procedure: The mirror neurons stimulation based VCD program
Procedure: The conventional physical therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The children were recruited from Thammasat University hospital and Rajanukul institute. Study period was two years which started from September 2009 to October 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty two children were assessed for their eligibility to participate in the study. One were excluded for failing to meet the inclusion criteria. One parent of a child refused to participate in the study.

Reporting Groups
  Description
The Mirror Neurons Stimulation Based VCD Program The children receive the mirror neurons stimulation based Video Compact Disc (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.
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.

Participant Flow:   Overall Study
    The Mirror Neurons Stimulation Based VCD Program     The Conventional Physical Therapy  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
The Mirror Neurons Stimulation Based VCD Program The children receive the mirror neurons stimulation based Video Compact Disc (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.
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.
Total Total of all reporting groups

Baseline Measures
    The Mirror Neurons Stimulation Based VCD Program     The Conventional Physical Therapy     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age [1]
[units: years]
Mean ± Standard Deviation
  6.2  ± 2.2     5.5  ± 2.2     5.9  ± 2.2  
Gender [2]
[units: participants]
     
Female     6     5     11  
Male     9     10     19  
Region of Enrollment  
[units: participants]
     
Thailand     15     15     30  
Baseline Gross Motor Function Measure (GMFM-66) score [3]
[units: Scores]
Mean ± Standard Deviation
  44.8  ± 14.0     49.4  ± 13.1     47.1  ± 13.5  
[1] The average age of each group
[2] The number of males and females of each group
[3] The mean total score of GMFM-66 of each group at entry. 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. GMFM-66 score less than 30 that are considered low gross motor skills.



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This Video Compact Disc (VCD) program was applicable for children with cerebral palsy with spastic diplegia who had high GMFCS level (1-3). Generalized the results to children with other types of cerebral palsy with different severity are limited.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Miss Namfon Mahasup
Organization: Postgraduate Studied Program, faculty of medicine, Thammasat University
phone: +66 867733596
e-mail: namfon_pt@yahoo.com


No publications provided


Responsible Party: Namfon Mahasup, Thammasat University
ClinicalTrials.gov Identifier: NCT01267929     History of Changes
Other Study ID Numbers: MTU-P-1-71/51
Study First Received: December 28, 2010
Results First Received: March 5, 2012
Last Updated: February 15, 2014
Health Authority: Thailand:Faculty of Medicine Thammasat University Ethics Commitee for Human Research