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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 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]

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

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Neurological

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

Gross motor function assesed by GMFM-Gross Motor Function Measure

Timepoint [1]

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]

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]

Primary outcome [3]

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]

Secondary outcome [1]

Spasticity assesed by Ashworth Scale

Timepoint [1]

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]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/04/2019

Date of last participant enrolment

Anticipated

Actual

8/04/2019

Date of last data collection

Anticipated

31/07/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Greece

State/province [1]

Athens

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Andreas Karamolegkos

Address [1]

Athens, 15772
Funding source’s work organisation:National and Kapodistrian University of Athens

Country [1]

Greece

Primary sponsor type

University

Name

National and Kapodistrian University of Athens

Address

Athens, 15772

Country

Greece

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Internal Committee for Research Ethics and Bioethics of the School of Physical Education and Sport Science

Ethics committee address [1]

Ethnikis Antistaseos 41, Dafni

Ethics committee country [1]

Greece

Date submitted for ethics approval [1]

Approval date [1]

16/01/2019

Ethics approval number [1]

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

Mr Andreas Karamolegkos

Address

Athens, 15772
National and Kapodistrian University of Athens
School of Physical Education and Sport Science

Country

Greece

Phone

+306949146306

Fax

[email protected]

Contact person for public queries

Name

Andreas Karamolegkos

Address

Athens, 15772
National and Kapodistrian University of Athens
School of Physical Education and Sport Science

Country

Greece

Phone

+306949146306

Fax

[email protected]

Contact person for scientific queries

Name

Skordilis Emmanouil

Address

Athens, 15772
National and Kapodistrian University of Athens
School of Physical Education and Sport Science

Country

Greece

Phone

+302107276024

Fax

[email protected]

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2015	Ethical approval					377534-(Uploaded-06-05-2019-21-03-10)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		The research was published in the International Jo... [More Details]	377534-(Uploaded-30-04-2020-01-56-10)-Journal results publication.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically