ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000117819

Ethics application status

Approved

Date submitted

5/12/2019

Date registered

5/02/2021

Date last updated

5/02/2021

Date data sharing statement initially provided

5/02/2021

Date results information initially provided

5/02/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Telerehabilitation with virtual reality in spastic hemiplegia cerebral palsy

Scientific title

Implementation of an exercise program with virtual reality via telerehabilitation for patients with cerebral palsy type spastic hemiplegia

Secondary ID [1]

Identifier issued by funding bodies:
Authority, Maule Regional Government - Chile
ID, 30.481.923-0

Universal Trial Number (UTN)

U1111-1243-4922

Trial acronym

TvrCP, Telerehabilitation virtual reality in Cerebral Palsy

Linked study record

Health condition

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

Cerebral Palsy

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Clinical trial parallel in patients with cerebral palsy. Two-arm, parallel-groups and randomised. Intervention exposure exercise program version "face to face" (control group) or "remote" (exposure group) both with Nintendo Wii balance board.
A virtual reality-based exercise protocol using Wii therapy (W-t) with Nintendo Wii balance board an “exposure-arm” performed by the parents or caregivers from patients' homes, and physiotherapists from the rehabilitation center and from the Special School each one will be guided remotely from the telerehabilitation center of the University of Talca. A total of 18 sessions W-t will be deliver over a period of 6 weeks with a frequency of 3 times per week (Monday, Wednesday and Friday) for 25 minutes each session and four weeks of follow-up in participant’s children and adolescent with spastic hemiplegic cerebral palsy. Each participants will execute three series of exercise with manual guidance and verbal instructions for the first 2 weeks and only verbal instructions by a parents or caregivers or physiotherapists in the following weeks. The first two series included Snowboard, Penguin Slide, and Super Hula Hoop; the third series was deep breathing in the Yoga game. The participants will be standing with their arms and hands at their sides, in a relaxed manner, during the first series. Each game will be repeat in a standing position and with their hands on their waist during second series. Finally, the participants will be instruct to maintain their posture and be as relaxed as possible with eyes open (EO) and later eyes closed (EC) during the third series. W-t will consist of a virtual reality training session using the Nintendo Wii balance board console for 25 min each session. This programme is based on previous studies, that demonstrate the training of balance is in all three planes of motion. For monitor adherence to the intervention will be through telephone reminders and direct observation by study personnel.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Comparator treatment will is face to face version:
A virtual reality-based exercise protocol using Wii therapy (W-t) with Nintendo Wii balance board this arm (face to face version, F/F) will perform only a physiotherapist towards the patient during six weeks of training and four weeks of follow-up in participant’s children and adolescent with spastic hemiplegic cerebral palsy. The exercise protocol is the same as for the exposure group, the difference is that the patient is face to face with the physiotherapist.

Control group

Active

Outcomes

Primary outcome [1]

Postural balance through CoP sway area (CoPSway), which is defined as the total trajectory that the CoP makes in the medial-lateral (ML) and anterior–posterior (AP) directions. Posturography (force plate) has been widely used to quantify balance, and is considered the gold standard within the laboratory equipment, as it is able to measure the amount of sway by using the center-of-pressure (CoP) displacements.
CoPSway have shown that this is a reliable and valid measure of balance during standing in different clinical and nonclinical populations. Greater values of CoP sway (i.e. sway area) indicate poorer balance control when standing still.
Participants stood on a force plate with their feet at shoulder–width distance and in a comfortable position. Posturography will be assess under six conditions for 30 seconds each: (i) eyes open (EO), (ii) eyes closed (EC), (iii) mediolateral displacement of body guided by auditory stimuli (sound) at a frequency of 30Hz and (iv) then 60Hz, both with EO and (v) mediolateral and (vi) anteroposterior displacement of body with virtual environment. Postural balance evaluation will be complete within 20 min.

Data were collected and recorded at 200 Hz using an AMTI OR6-7 forceplate and AMTI-NetForce software (AMTI Inc., Boston, MA, USA). A procedure written in Matlab R2012 (Mathworks Inc., Natick, MA, USA) was used for low-pass filtering data (second-order Butterworth, 40 Hz cut-off frequency).

Timepoint [1]

Baseline, at 2, 4 and 6 weeks (primary timepoint) during the intervention (a Friday or the last day of these weeks), and 8 and 10 weeks (follow up) a Friday or in the last day of these weeks, respectively.

Secondary outcome [1]

Standard desviation of CoP in the mediolateral (SDML) and the anterior-posterior (SDAP) directions, are a composite secondary outcome. Standard deviation measures (SDML and SDAP), both reflect the variability of the CoP displacements, hence, of the motor responses aimed to minimize postural sway.
Participants stood on a force plate with their feet at shoulder–width distance and in a comfortable position. Posturography will be assess under six conditions for 30 seconds each: (i) eyes open (EO), (ii) eyes closed (EC), (iii) mediolateral displacement of body guided by auditory stimuli (sound) at a frequency of 30Hz and (iv) then 60Hz, both with EO and (v) mediolateral and (vi) anteroposterior displacement of body with virtual environment. Postural balance evaluation will be complete within 20 min.
Data were collected and recorded at 200 Hz using an AMTI OR6-7 forceplate and AMTI-NetForce software (AMTI Inc., Boston, MA, USA). A procedure written in Matlab R2012 (Mathworks Inc., Natick, MA, USA) was used for low-pass filtering data (second-order Butterworth, 40 Hz cut-off frequency).

Timepoint [1]

Baseline, at 2, 4 and 6 weeks during the intervention (a Friday or the last day of these weeks), and 8 and 10 weeks (follow up) a Friday or in the last day of these weeks, respectively.

Secondary outcome [2]

Velocity of CoP in in the mediolateral (VML) and the anterior-posterior (VAP) directions, are a composite secondary outcome. Greater values for CoPSway indicates poorer balance control as CoP gets closer to the limit of stability, which demands rapid stabilization responses expressed in greater CoP velocities (VML and VAP).
Participants stood on a force plate with their feet at shoulder–width distance and in a comfortable position. Posturography will be assess under six conditions for 30 seconds each: (i) eyes open (EO), (ii) eyes closed (EC), (iii) mediolateral displacement of body guided by auditory stimuli (sound) at a frequency of 30Hz and (iv) then 60Hz, both with EO and (v) mediolateral and (vi) anteroposterior displacement of body with virtual environment. Postural balance evaluation will be complete within 20 min.
Data were collected and recorded at 200 Hz using an AMTI OR6-7 forceplate and AMTI-NetForce software (AMTI Inc., Boston, MA, USA). A procedure written in Matlab R2012 (Mathworks Inc., Natick, MA, USA) was used for low-pass filtering data (second-order Butterworth, 40 Hz cut-off frequency).

Timepoint [2]

Baseline, at 2, 4 and 6 weeks during the intervention (a Friday or the last day of these weeks), and 8 and 10 weeks (follow up) a Friday or in the last day of these weeks, respectively.

Eligibility

Key inclusion criteria

- Volunteer participants with Spastic Hemiplegia Cerebral Palsy.
- Level I or II of the Gross Motor Function Classification System (GMFCS).
- Understand the procedures to be performed (full-scale intelligence quotient, FSIQ, <80).

Minimum age

7 Years

Maximum age

14 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Patients with other neurological disorders, such as epilepsy.
- Patients with uncorrected vision and hearing disorders.
- Previous surgeries in lower limb over the last 10 months or application Botulinum Toxin-A in the lower limb over the past 10 months.
- Participants with access to a Nintendo Wii at home.

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)

Central randomisation by computer (software IBM-SPSS 20.00, Inc., Armonk, NY, USA) with an identification ID and without a preset order. In this way, two random samples (face to face and remote version) will be extracted.

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

Simple randomisation using a randomisation table created by computer software.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The sample size was calculated in order to detect clinically relevant changues in the effects postural balance of W-t face to face versus remote version at six weeks. Based on data from earlier studies (V.F Gatica et al., 2014; Gatica-Rojas V, et al., 2017; Gatica-Rojas V, et al., 2017), We considered a standard deviation of 4.974 cm2, a significance alpha level of 0.05, 80% statistical power, and with an allowance for 5% attrition, we required a minimum of 20 participants in each group (total sample of 40).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

14/10/2019

Date of last participant enrolment

Anticipated

Actual

7/02/2020

Date of last data collection

Anticipated

Actual

28/02/2020

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Chile

State/province [1]

Talca

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Maule Regional Government - Chile

Address [1]

Calle 1 Nte. 731, Talca Cyty, Maule Región, Chile

Country [1]

Chile

Primary sponsor type

Government body

Name

Maule Regional Government

Address

Calle 1 Nte. 731, Talca Cyty, Maule Región.

Country

Chile

Secondary sponsor category [1]

University

Name [1]

Universidad de Talca

Address [1]

Calle Cardenal Raúl Silva Henríquez (Ex 1 Poniente) 1441, 4° Piso, Talca

Country [1]

Chile

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comité Ético Científico, Universidad de Talca

Ethics committee address [1]

Avenida Lircay S/N, Talca, Chile.

Ethics committee country [1]

Chile

Date submitted for ethics approval [1]

07/08/2018

Approval date [1]

26/09/2018

Ethics approval number [1]

24-2018

Summary

Brief summary

This research project seeks to implement an exercise program with virtual environments generated through the Nintendo Wii console and the balance board (Wii therapy, W-t) via telerehabilitation to improvement the postural balance in children and adolescents with cerebral palsy of type spastic hemiplegia. A clinical trial design whose objective will be to compare the effectiveness in improvement postural balance of face-to-face Wii therapy (physiotherapist with the patient) versus remote (parents / caregivers). Wii therapy face to face versus remote version are equivalent in their effects for the postural balance.

Trial website

https://cttn.cl/fic/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Valeska Gatica-Rojas

Address

Tele-rehabilitation technology center and Neurosciences in Human Movement, Faculty of Health Sciences, Universidad de Talca, Av. Lircay S/N, Talca, Chile.

Country

Chile

Phone

+56 71 2418859

Fax

[email protected]

Contact person for public queries

Name

Miss Mariel Mena

Address

Universidad de Talca, Av. Lircay S/N, Talca, Chile

Country

Chile

Phone

+56 71 2414646

Fax

[email protected]

Contact person for scientific queries

Name

Dr Valeska Gatica-Rojas

Address

Tele-rehabilitation technology center and Neurosciences in Human Movement, Faculty of Health Sciences, Universidad de Talca, Av. Lircay S/N, Talca, Chile.

Country

Chile

Phone

+56 71 2418859

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?

Individual participant data underlying published results only for example primary and secondary outcome.

When will data be available (start and end dates)?

Immediately following publication and ending 2 years following main results publication.

Available to whom?

Case-by-case basis at the discretion of Primary Sponsor (Maule Regional Government).

Available for what types of analyses?

For IPD meta-analyses.

How or where can data be obtained?

Access subject to approvals by Principal Investigator ([email protected]; +56 71 2418859; +56 988393227) and Maule Regional Government ([email protected]).

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6039	Ethical approval			[email protected]		378729-(Uploaded-05-12-2019-00-34-17)-Study-related document.pdf
6040	Informed consent form			[email protected]		378729-(Uploaded-05-12-2019-01-02-09)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Postural control telerehabilitation with a low-cost virtual reality protocol for children with cerebral palsy: Protocol for a clinical trial.	2022	https://dx.doi.org/10.1101/2022.04.25.22274289

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically