Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention Phase
Children With Spastic Diplegia Aged Between 2-10 Years.
Gross Motor Function Classification System (GMFCS) Level of 1-3.
Procedure: The mirror neurons stimulation based VCD program
Procedure: The conventional physical therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Thammasat University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: September 2009
Study Completion Date: October 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267929

Locations
Thailand
Department of Physical therapy, Faculty of Allied Health Sciences Thammasat University
Klongluang, 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

No publications provided

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
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

Keywords provided by 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

ClinicalTrials.gov processed this record on November 25, 2014