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

Children With Spastic Diplegia, Between the Ages of 2 to 10 Years Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267929
• Other study ID #: MTU-P-1-71/51
• Status: Completed
• Phase: N/A
• First received: December 28, 2010
• Last updated: November 10, 2017
• Start date: September 2009
• Est. completion date: October 2011

Study information

• Verified date: November 2017
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Thailand	Department of Physical therapy, Faculty of Allied Health Sciences Thammasat University	Pathumthani

Sponsors (2)

Lead Sponsor	Collaborator
Thammasat University	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Base line, two months and six months