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Trial registered on ANZCTR


Registration number
ACTRN12619000781145
Ethics application status
Approved
Date submitted
10/05/2019
Date registered
27/05/2019
Date last updated
27/05/2019
Date data sharing statement initially provided
27/05/2019
Date results information initially provided
27/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a virtual reality game device on the functioning of children and adolescents with motor disabilities
Scientific title
The effect of a head mounted display virtual reality game device on the functioning of children and adolescents with cerebral palsy
Secondary ID [1] 298155 0
Nil Known
Universal Trial Number (UTN)
U1111-1232-8187
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 312704 0
Condition category
Condition code
Physical Medicine / Rehabilitation 311205 311205 0 0
Physiotherapy
Neurological 311344 311344 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental group will participate in a virtual reality game program with a head mounted display(HMD) device (HTC Vive) while continuing the physiotherapy program of the rehabilitation center in Athens.
The duration of the physiotherapy program is 45 minutes,the frequency is twice per week and involves exercises for muscle strengthening,for better balance, functional activities like riding a bicycle, walking on a treadmill and climbing stairs and techniques-exercises from the neurodevelopmental therapy. A physiotherapist is responsible for the administration of the therapy.He/She uses only simple equipment like pilates balls,layers and rolls. Children receive the physiotherapy program regardless they are involved in this study.
The intervention with the HMD will be delivered once a week for 8 weeks.The duration of the intervention will be 45 minutes.
Each child will participate alone.
The two games, which children will play, will be selected based on children's preferences, through a list of several games, during their familiarization with the HMD device.
In the first game,that called "Beat Saber", children hold the 2 controllers (in the game they see them as light sabers) and they have to cut blue and red cubes in the rythm of the music they have chosen, while they are trying to avoid obstacles like walls.In the second game called "Arcade Saga", children hold the 2 controllers (in the game they see them as shields) and they have to punch a ball (small,big,a dozen of balls or a very fast ball.That depends on moving cubes that change the condition of the ball if the ball hits them) and score 7 or 9 goals, depends on the level, to win the computer.They can also slow down the ball with yellow circle rays by targetting the ball and pressing the trigger button.
The intervention will be delivered by the researcher, but the assessments with the functional tests at the beginning of the research,at the end 8 weeks later and 8 weeks after the end will be done by the physiotherapists of each child.
The researcher will be present when children will play and will guide them.
A diary will be used to monitor adherence to the intervention.In the diary the researcher will record the days when each child comes and the results from each game to increase each time their degree of difficulty and at the same time to know their progress.
Intervention code [1] 314377 0
Rehabilitation
Intervention code [2] 314378 0
Treatment: Other
Intervention code [3] 314379 0
Treatment: Devices
Comparator / control treatment
The control group will continue to follow the physiotherapy program of the rehbilitation center.
Control group
Active

Outcomes
Primary outcome [1] 319963 0
Gross motor function assesed by GMFM-Gross Motor Function Measure
Timepoint [1] 319963 0
Baseline(before we start the intervention), 8 weeks later after the intervention to the determine the effects of the intervention(in the fisrt week after the intervention has ended-primary timepoint) and 8 weeks after the end of intervention(int the first week after completing these 8 weeks)
Primary outcome [2] 319964 0
Walking assesed by GMFM-Gross Motor Function Measure, Time Up and Go(TUG), 1 Minute Walking Test and by 10 Meters Walking Test
Timepoint [2] 319964 0
Baseline(before we start the intervention), 8 weeks later after the intervention to the determine the effects of the intervention(in the fisrt week after the intervention has ended-primary timepoint) and 8 weeks after the end of intervention(int the first week after completing these 8 weeks)
Primary outcome [3] 319965 0
Movement and Changes in body position assesed by Time Up and Go(TUG), 1 Minute Walking Test, 10 Meters Walking Test and by 30 seconds Sit to Stand Test
This a composite primary outcome.
Timepoint [3] 319965 0
Baseline(before we start the intervention), 8 weeks later after the intervention to the determine the effects of the intervention(in the fisrt week after the intervention has ended-primary timepoint) and 8 weeks after the end of intervention(int the first week after completing these 8 weeks)
Secondary outcome [1] 369995 0
Spasticity assesed by Ashworth Scale
Timepoint [1] 369995 0
Baseline(before we start the intervention), 8 weeks later after the intervention(in the fisrt week after the intervention has ended) and 8 weeks after the end of intervention(int the first week after completing these 8 weeks)
Secondary outcome [2] 369996 0
Range Of Motion assessed by a goniometer.This is a composite secondary outcome.
We will assess the passive range of motion of shoulder abduction, elbow extension, wrist extension, hip abduction,hip flection, knee extension and ankle dorsi flexion.
Timepoint [2] 369996 0
Baseline(before we start the intervention), 8 weeks later after the intervention(in the fisrt week after the intervention has ended) and 8 weeks after the end of intervention(int the first week after completing these 8 weeks)

Eligibility
Key inclusion criteria
Children and adolescents diagnosed with cerebral palsy,ability to understand simple instructions, ability to walk with or without aids (Gross Motor Function Classification System-GMFCS E & R levels I-III),not participating in other organized extracurricular activities during the afternoon hours,absence of epilepsy and non-involvement in therapeutic approaches such as orthopedic surgery or injection of botulinum toxin A (Botox-A) into hypertonic muscles over the last 6 months.
Minimum age
10 Years
Maximum age
13 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
children with a more heavy form of cerebral palsy(GMFSC IV-V),children aged less than 10 years old and older than 13 years of age,children with cerebral palsy and lower mental ability,children that not living in Athens.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
At the same time the experimental and the control group will do their phyiotherapies, but in advance the experimental group will play 2 games once in a week for 8 weeks with the virtual reality HMD device.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
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] 21456 0
Greece
State/province [1] 21456 0
Athens

Funding & Sponsors
Funding source category [1] 302683 0
Self funded/Unfunded
Name [1] 302683 0
Andreas Karamolegkos
Address [1] 302683 0
Athens, 15772
Funding source’s work organisation:National and Kapodistrian University of Athens
Country [1] 302683 0
Greece
Primary sponsor type
University
Name
National and Kapodistrian University of Athens
Address
Athens, 15772
Country
Greece
Secondary sponsor category [1] 302626 0
None
Name [1] 302626 0
Address [1] 302626 0
Country [1] 302626 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303301 0
Internal Committee for Research Ethics and Bioethics of the School of Physical Education and Sport Science
Ethics committee address [1] 303301 0
Ethnikis Antistaseos 41, Dafni
Ethics committee country [1] 303301 0
Greece
Date submitted for ethics approval [1] 303301 0
Approval date [1] 303301 0
16/01/2019
Ethics approval number [1] 303301 0

Summary
Brief summary
Cerebral palsy refers to impairment of the developing brain's motor centers leading to motor control deficits and disruption in body position and movement. It is characterized by pathological reflexes, muscle tone disorders and absence of coordinated and voluntary movements, thus influencing the person's skills and ability to respond to his / her daily activities (Rosenbaum et al., 2007; Himmelmann et al., 2006).
In recent years, virtual reality devices have often been used as an ancillary remedy for children and adolescents with cerebral palsy. This is probably due to the capabilities they provide (e.g difficulty adjustment, feedback) and the interactive experience children experience through the game (Levac et al., 2012; Pereira et al., 2014). However, it is noted that the efficiency of the most modern virtual reality devices, namely Head Mounted Displays (HMD), has not yet been studied. For this reason, the aim of this research is to evaluate the application of modern Head Mounted Displays (HMDs) to children and adolescents with cerebral palsy and to examine their impact on their daily functionality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93194 0
Mr Andreas Karamolegkos
Address 93194 0
Athens, 15772
National and Kapodistrian University of Athens
School of Physical Education and Sport Science
Country 93194 0
Greece
Phone 93194 0
+306949146306
Fax 93194 0
Email 93194 0
adreaskaramolegos@hotmail.com
Contact person for public queries
Name 93195 0
Mr Andreas Karamolegkos
Address 93195 0
Athens, 15772
National and Kapodistrian University of Athens
School of Physical Education and Sport Science
Country 93195 0
Greece
Phone 93195 0
+306949146306
Fax 93195 0
Email 93195 0
adreaskaramolegos@hotmail.com
Contact person for scientific queries
Name 93196 0
Prof Skordilis Emmanouil
Address 93196 0
Athens, 15772
National and Kapodistrian University of Athens
School of Physical Education and Sport Science
Country 93196 0
Greece
Phone 93196 0
+302107276024
Fax 93196 0
Email 93196 0
eskord@phed.uoa.gr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Available for data analysis will be the outcome from the assessments.
Qualitative data will be available from the diary kept throughout the
intervention.
When will data be available (start and end dates)?
At the end of the study and after the research been published.
IPD availability: No end date determined.
Available to whom?
To the research team, for data analysis only, and the chair of the institution. Parents and clinicians will also have access to the data of their own children/ patients (if they so desire).
Available for what types of analyses?
ANCOVA will be conducted to evaluate the effect of the intervention study.
The data will be available only to achieve the aims in the approved proposal.
How or where can data be obtained?
Writting a general report, or consultation in a private basis with the parents and the clinicians working with our sample.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2015 0
Ethical approval
Citation [1] 2015 0
Link [1] 2015 0
Email [1] 2015 0
Other [1] 2015 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary