Children With Spastic Diplegia, Between the Ages of 2 to 10 YearsNCT01267929

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

A study testing The mirror neurons stimulation based VCD program and The conventional physical therapy in people with Children With Spastic Diplegia, Between the Ages of 2 to 10 Years and Gross Motor Function Classification System (GMFCS) Level I,II and III, run by Thammasat University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 10 years
Conditions the study is for: Children With Spastic Diplegia, Between the Ages of 2 to 10 Years, Gross Motor Function Classification System (GMFCS) Level I,II and III
What is being tested?: The mirror neurons stimulation based VCD program and The conventional physical therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteThailand
Study dates: Sep 2009to Oct 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Department of Physical therapy, Faculty of Allied Health Sciences Thammasat University
Pathum Thani, 12120

Other trials in Thailand

About this study

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.

Read the 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).

Conditions: Children With Spastic Diplegia, Between the Ages of 2 to 10 Years, Gross Motor Function Classification System (GMFCS) Level I,II and III
Being tested: The mirror neurons stimulation based VCD program, The conventional physical therapy
Keywords: Children with cerebral palsy, Gross Motor Function Measure, Imitative learning, Mirror neuron, Action observation, Conventional physical therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The mirror neurons stimulation based VCD programProcedure or surgery
The children receive the mirror neurons stimulation based VCD program and practice at home three times a day for six months.
The conventional physical therapyProcedure or surgery
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.

Study groups in NCT01267929
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: The conventional physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Base line, two months and six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Oct 2011

First posted29 Dec 2010 (estimated)
Study startSep 2009
Primary completionAug 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Children With Spastic Diplegia, Between the Ages of 2 to 10 YearsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01267929
Sponsor's protocol ID: MTU-P-1-71/51
Status last verified: Nov 2017
First submitted: 28 Dec 2010
Last updated: 18 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Mirror Neurons Stimulation on Motor Skill Rehabilitation in Children With Cerebral Palsy
ClinicalTrials.gov ID: NCT01267929
Acronym / sponsor ID: MTU-P-1-71/51
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Thammasat UniversityUniversity, hospital or other
Collaborators: National Research Council of Thailand
Study start: Sep 2009
Primary completion: Aug 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 29 Dec 2010 (estimated)
Results: Posted 17 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
The mirror neurons stimulation based VCD program	Experimental	Procedure: The mirror neurons stimulation based VCD programThe 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 conventional physical therapy	Active comparator	Procedure: The conventional physical therapyThe 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.

Who may qualify

Ages: 2 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The mirror neurons stimulation based VCD programThe children receive the mirror neurons stimulation based VCD program and practice at home three times a day for six months.	Procedure or surgery	The mirror neurons stimulation based VCD program
The conventional physical therapyThe 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.	Procedure or surgery	The conventional physical therapy

Primary outcome

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.

Results and safety

Results posted to the registry on 17 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
The Mirror Neurons Stimulation Based VCD Program	15	15
The Conventional Physical Therapy	15	15

Primary outcome: 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. Mean (Standard Deviation). Unit: Scores on a scale

Measure	The Mirror Neurons Stimulation Based VCD Program n = 15	The Conventional Physical Therapy n = 15
The mean score of GMFM-66 at the entry	44.8 (14.0)	49.4 (13.1)
The mean score of GMFM-66 at the second month	54.7 (14.5)	57.5 (16.2)
The mean score of GMFM-66 at the sixth month	57.8 (13.9)	63.2 (16.8)

The Mirror Neurons Stimulation Based VCD Program vs The Conventional Physical Therapy: Mean Difference (Final Values): 2.1 (95% CI -2.3 to 6.5), p = 0.34, ANCOVA
The Mirror Neurons Stimulation Based VCD Program vs The Conventional Physical Therapy: Mean Difference (Net): -0.7 (95% CI -6.3 to 4.7), p = 0.78, ANCOVA

Population analysed: A total of 30 children with cerebral palsy was followed and completed the study.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The Mirror Neurons Stimulation Based VCD Program	0 of 30 (0%)	0 of 30 (0%)	Not reported
The Conventional Physical Therapy	0 of 30 (0%)	0 of 30 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Assoc.Prof.Paskorn Sritipsukho, MD study director

Thailand:Faculty of Medicine Thammasat University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01267929.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2017.