ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001013752

Ethics application status

Approved

Date submitted

10/06/2022

Date registered

19/07/2022

Date last updated

19/07/2022

Date data sharing statement initially provided

19/07/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

The Effects of Virtual Reality-Based Therapy on Physical Functions, Physical Activity, and Quality of Life in Children and Adolescents with Cerebral Palsy

Scientific title

The Effects of Virtual Reality-Based Therapy on Physical Functions, Physical Activity, and Quality of Life in Children and Adolescents with Cerebral Palsy

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1272-3075

Trial acronym

VRT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cerebral Palsy

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The exercises chosen for VR-based therapy mainly includes activities in standing, for instance marching, side stepping, upper limb movements, squatting and jumping. Participants will come for the VR sessions two times per week with duration of one hour per session, and the whole program lasts 12 weeks. Warming up and cooling down session will be performed around 5 minutes prior and at the end of the each session, respectively. During warm up, upper and lower limb stretches are done following with static and dynamic marching. Whereas for cool down, upper and lower limb stretches are done. The whole intervention session will be conducted by the researcher, and to monitor the adherence of participants to the intervention, the session attendance will be recorded.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Control group will be continuing their regular Cerebral Palsy Rehabilitation Program as usual. Only assessments will be done pre and post 6 and 12 weeks of trial.

Treatments may include:
1. Stretching
2. Gait Training
3. Strengthening Exercise
4. Functional Activities Training

Control group

Active

Outcomes

Primary outcome [1]

Walking Performance, assessed with 6 Minute Walking Test

Timepoint [1]

At the 6th Week and 12th Week of the trial. (Primary End Point)

Primary outcome [2]

Lower Limb Muscle Strength, assessed with Micro-FET Dynamometer.

Timepoint [2]

At the 6th Week and 12th Week of the trial. (Primary End Point)

Primary outcome [3]

Gross Motor Function, Assessed with Gross Motor Function Measure-66 (GMFM-66) Component D & E.

Timepoint [3]

At the 6th Week and 12th Week of the trial. (Primary End Point)

Secondary outcome [1]

Level of Physical Activity, Assessed with Activpal

Timepoint [1]

At the 6th Week and 12th Week of the trial.

Secondary outcome [2]

Quality of Life, Assessed with PedsQoL (Bahasa Malaysia Version)

Timepoint [2]

At the 6th Week and 12th Week of the trial.

Eligibility

Key inclusion criteria

1. Malaysian
2. Gross Motor Function Classification System (GMFCS) Level I, II & III
3. Age ranging between 7-17 years old
4. Not enrolled in any specific/structured fitness programs
5. Able to walk with or without assistive devices

Minimum age

7 Years

Maximum age

17 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Treatment with botulinum toxin A in lower limb and/or serial casting of lower limb less than 6 months before the start of the training
2. History of Orthopedic Surgery Procedure within 6months prior of the program

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomized concealed allocation by researcher's supervisor before the treatment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Stratified allocation according to Gross Motor Function Classification System

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

All the results will be analyzed using the Statistical Products and Service Solution (SPSS) version 26.0. The data will be analyzed by using the descriptive statistics of mean and standard deviation, analysis of prevalence, logistic and linear regression and moderation analysis. Independent sample T-test will be used to compare the means of both intervention groups and control groups in order to determine whether there is any significant difference between the means of baseline data of both groups. One Way Manova Test will be performed to assess the interaction between and within group over time. A p value of 0.05 is set as the level of statistical significance for the primary and secondary outcome. For the measurement of effect size, Cohen's d is used and a d value of 0.6 is considered to be large. Power of the statistical test is set at 80%.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

20/06/2022

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Kuala Lumpur

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Ministry of Higher Education Malaysia

Address [1]

No. 2, Menara 2, Jalan P5/6, Precinct 5, Federal Government Administrative Centre, 62200 Putrajaya.

Country [1]

Malaysia

Primary sponsor type

Government body

Name

Ministry of Higher Education Malaysia

Address

No. 2, Menara 2, Jalan P5/6, Precinct 5, Federal Government Administrative Centre, 62200 Putrajaya.

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Universiti Kebangsaan Malaysia Research Ethics Committee

Ethics committee address [1]

Hospital Canselor Tuanku Muhriz, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

07/01/2022

Approval date [1]

02/06/2022

Ethics approval number [1]

Summary

Brief summary

Cerebral Palsy (CP) has been one of the major disabling motor disorders which affects a children’s Quality of Life (QoL) to different extents depending on the severity of the condition. Being the most common motor disability among children, Centers for Disease Control and Prevention has reported prevalence estimating 1 to nearly 4 per 1,000 live births worldwide. According to the report by the Department of Statistics Malaysia in 2020, there are approximately 20,300 children with Disability (CWD). Based on the estimated prevalence of 1 to 4 CP children per 1000 live births among 9.3 million children among the Malaysian population, the actual number of CP children in Malaysia may be significantly higher. Virtual Reality as a new leading tool in rehabilitation possesses its ability to solve limitations in current practices such as (1) Musculoskeletal-pain and additional impairments related to activity limitations; (2) knowledge and exercising skills; (3) availability; (4) social support due to its unique traits of being virtual and recreational-oriented. Owing to the huge CP population and the lack of literatures reviewing effect of Virtual Reality-based Therapy (VRT) on CP patients locally, it is timely to assess the effect of VRT on physical function and QoL of children and adolescents with CP to provide fundamental data for clinicians in assessing CP patients as well as serving as an intervention guideline for future practices. In our research, we will be focusing on aspects of impairments such as strength, walking capacity,gross motor function, level of physical activities and Quality of Life among CP children and adolescents between 7 to 17 years old. The subjects will be recruited from local Physiotherapy Clinic and also Hospital based on the inclusion criterias stated. They will then be divided into 2 groups in a blinded way to a control group which continues routine physiotherapy and also a VRT intervention group for 12 weeks with assessments on 6th and 12th week to note for improvements.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Asfarina Zanudin

Address

Physiotherapy Program
Faculty of Health Sciences
Universiti Kebangsaan Malaysia Kampus Kuala Lumpur
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur

Country

Malaysia

Phone

+601128177381

Fax

asfarina.zanudin@ukm.edu.my

Contact person for public queries

Name

Asfarina Zanudin

Address

Physiotherapy Program
Faculty of Health Sciences
Universiti Kebangsaan Malaysia Kampus Kuala Lumpur
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur

Country

Malaysia

Phone

+601128177381

Fax

asfarina.zanudin@ukm.edu.my

Contact person for scientific queries

Name

Asfarina Zanudin

Address

Physiotherapy Program
Faculty of Health Sciences
Universiti Kebangsaan Malaysia Kampus Kuala Lumpur
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur

Country

Malaysia

Phone

+601128177381

Fax

asfarina.zanudin@ukm.edu.my

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

The data are private and confidential.

What supporting documents are/will be available?

Doc. No.	Type	Email
14611	Study protocol	asfarina.zanudin@ukm.edu.my
14612	Ethical approval	asfarina.zanudin@ukm.edu.my
14613	Informed consent form	asfarina.zanudin@ukm.edu.my

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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