Completed

NCT Number: NCT01267929

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

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.

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Key information

Conditions

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

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pathum Thani, 12120, Thailand

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The mirror neurons stimulation based VCD program

Procedure

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

Procedure

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Collaborators

National Research Council of Thailand

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Dec 29, 2010
Registry last updated: Dec 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.