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

November 10, 2017 updated by: Namfon Mahasup, Thammasat University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Pathumthani, Thailand, 12120
        • Department of Physical therapy, Faculty of Allied Health Sciences Thammasat University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Base line, two months and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thammasat University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Research Council of Thailand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Assoc.Prof.Paskorn Sritipsukho, MD, Thailand:Faculty of Medicine Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MTU-P-1-71/51

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