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

Primary Purpose

Children With Spastic Diplegia, Between the Ages of 2 to 10 Years, Gross Motor Function Classification System (GMFCS) Level I,II and III

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
The mirror neurons stimulation based VCD program
The conventional physical therapy
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children With Spastic Diplegia, Between the Ages of 2 to 10 Years focused on measuring Children with cerebral palsy, Gross Motor Function Measure, Imitative learning, Mirror neuron, Action observation, Conventional physical therapy

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical therapy, Faculty of Allied Health Sciences Thammasat University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The mirror neurons stimulation based VCD program

The conventional physical therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month.
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.

Secondary Outcome Measures

Full Information

First Posted
December 28, 2010
Last Updated
November 10, 2017
Sponsor
Thammasat University
Collaborators
National Research Council of Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT01267929
Brief Title
Effects of Mirror Neurons Stimulation on Motor Skill Rehabilitation in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
Collaborators
National Research Council of Thailand

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children With Spastic Diplegia, Between the Ages of 2 to 10 Years, Gross Motor Function Classification System (GMFCS) Level I,II and III
Keywords
Children with cerebral palsy, Gross Motor Function Measure, Imitative learning, Mirror neuron, Action observation, Conventional physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The mirror neurons stimulation based VCD program
Arm Type
Experimental
Arm Description
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.
Arm Title
The conventional physical therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
The mirror neurons stimulation based VCD program
Intervention Description
The children receive the mirror neurons stimulation based VCD program and practice at home three times a day for six months.
Intervention Type
Procedure
Intervention Name(s)
The conventional physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Gross Motor Function Measure (GMFM-66) Score at Entry, the Second and the Sixth Month.
Description
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.
Time Frame
Base line, two months and six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assoc.Prof.Paskorn Sritipsukho, MD
Organizational Affiliation
Thailand:Faculty of Medicine Thammasat University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Physical therapy, Faculty of Allied Health Sciences Thammasat University
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand

12. IPD Sharing Statement

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

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