Trial Review

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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] 305980 0
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 324600 0
Condition category
Condition code
Neurological 322056 322056 0 0
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] 322376 0
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] 329817 0
Walking Performance, assessed with 6 Minute Walking Test
Timepoint [1] 329817 0
At the 6th Week and 12th Week of the trial. (Primary End Point)
Primary outcome [2] 329818 0
Lower Limb Muscle Strength, assessed with Micro-FET Dynamometer.
Timepoint [2] 329818 0
At the 6th Week and 12th Week of the trial. (Primary End Point)
Primary outcome [3] 331629 0
Gross Motor Function, Assessed with Gross Motor Function Measure-66 (GMFM-66) Component D & E.
Timepoint [3] 331629 0
At the 6th Week and 12th Week of the trial. (Primary End Point)
Secondary outcome [1] 403953 0
Level of Physical Activity, Assessed with Activpal
Timepoint [1] 403953 0
At the 6th Week and 12th Week of the trial.
Secondary outcome [2] 403954 0
Quality of Life, Assessed with PedsQoL (Bahasa Malaysia Version)
Timepoint [2] 403954 0
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?
No
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
28
Accrual to date
4
Final
Recruitment outside Australia
Country [1] 24375 0
Malaysia
State/province [1] 24375 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 310321 0
Government body
Name [1] 310321 0
Ministry of Higher Education Malaysia
Country [1] 310321 0
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] 311656 0
None
Name [1] 311656 0
Address [1] 311656 0
Country [1] 311656 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309983 0
Universiti Kebangsaan Malaysia Research Ethics Committee
Ethics committee address [1] 309983 0
Hospital Canselor Tuanku Muhriz, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Ethics committee country [1] 309983 0
Malaysia
Date submitted for ethics approval [1] 309983 0
07/01/2022
Approval date [1] 309983 0
02/06/2022
Ethics approval number [1] 309983 0

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 116074 0
Dr Asfarina Zanudin
Address 116074 0
Physiotherapy Program
Faculty of Health Sciences
Universiti Kebangsaan Malaysia Kampus Kuala Lumpur
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 116074 0
Malaysia
Phone 116074 0
+601128177381
Fax 116074 0
Email 116074 0
asfarina.zanudin@ukm.edu.my
Contact person for public queries
Name 116075 0
Dr Asfarina Zanudin
Address 116075 0
Physiotherapy Program
Faculty of Health Sciences
Universiti Kebangsaan Malaysia Kampus Kuala Lumpur
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 116075 0
Malaysia
Phone 116075 0
+601128177381
Fax 116075 0
Email 116075 0
asfarina.zanudin@ukm.edu.my
Contact person for scientific queries
Name 116076 0
Dr Asfarina Zanudin
Address 116076 0
Physiotherapy Program
Faculty of Health Sciences
Universiti Kebangsaan Malaysia Kampus Kuala Lumpur
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 116076 0
Malaysia
Phone 116076 0
+601128177381
Fax 116076 0
Email 116076 0
asfarina.zanudin@ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data are private and confidential.


What supporting documents are/will be available?

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



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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