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

NCT01267929 | Completed Results DMC

• 1 other identifier: MTU-P-1-71/51
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

The mirror neurons stimulation based VCD program

EXPERIMENTAL

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 conventional physical therapy

ACTIVE COMPARATOR

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

Interventions

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 mirror neurons stimulation based VCD program

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.

The conventional physical therapy

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thammasat University: lead
• National Research Council of Thailand: collaborator

Study Sites (1)

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

Pathum Thani, 12120, Thailand

Location

Limitations and Caveats

This Video Compact Disc (VCD) program was applicable for children with cerebral palsy with spastic diplegia who had high GMFCS level (1-3). Generalized the results to children with other types of cerebral palsy with different severity are limited.

Results Point of Contact

• Title: Miss Namfon Mahasup
• Organization: Postgraduate Studied Program, faculty of medicine, Thammasat University

namfon_pt@yahoo.com

+66 867733596

Study Officials

• Assoc.Prof.Paskorn Sritipsukho, MD

  Thailand:Faculty of Medicine Thammasat University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.candidate, Postgraduate Studied Program, faculty of Medicine, Thammasat University

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 29, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 18, 2017
• Results First Posted: February 17, 2014

Record last verified: 2017-11

Locations

TH (1)