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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 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] 299796 0
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 315232 0
Condition category
Condition code
Neurological 313538 313538 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 313539 313539 0 0
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] 316093 0
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] 322145 0
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] 322145 0
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] 377477 0
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] 377477 0
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] 378357 0
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] 378357 0
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?
No
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
40
Accrual to date
Final
37
Recruitment outside Australia
Country [1] 22162 0
Chile
State/province [1] 22162 0
Talca

Funding & Sponsors
Funding source category [1] 304260 0
Government body
Name [1] 304260 0
Maule Regional Government - Chile
Country [1] 304260 0
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] 304716 0
University
Name [1] 304716 0
Universidad de Talca
Address [1] 304716 0
Calle Cardenal Raúl Silva Henríquez (Ex 1 Poniente) 1441, 4° Piso, Talca
Country [1] 304716 0
Chile

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304715 0
Comité Ético Científico, Universidad de Talca
Ethics committee address [1] 304715 0
Ethics committee country [1] 304715 0
Chile
Date submitted for ethics approval [1] 304715 0
07/08/2018
Approval date [1] 304715 0
26/09/2018
Ethics approval number [1] 304715 0
24-2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97974 0
Dr Valeska Gatica-Rojas
Address 97974 0
Tele-rehabilitation technology center and Neurosciences in Human Movement, Faculty of Health Sciences, Universidad de Talca, Av. Lircay S/N, Talca, Chile.
Country 97974 0
Chile
Phone 97974 0
+56 71 2418859
Fax 97974 0
Email 97974 0
[email protected]
Contact person for public queries
Name 97975 0
Mariel Mena
Address 97975 0
Universidad de Talca, Av. Lircay S/N, Talca, Chile
Country 97975 0
Chile
Phone 97975 0
+56 71 2414646
Fax 97975 0
Email 97975 0
[email protected]
Contact person for scientific queries
Name 97976 0
Valeska Gatica-Rojas
Address 97976 0
Tele-rehabilitation technology center and Neurosciences in Human Movement, Faculty of Health Sciences, Universidad de Talca, Av. Lircay S/N, Talca, Chile.
Country 97976 0
Chile
Phone 97976 0
+56 71 2418859
Fax 97976 0
Email 97976 0
[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.TypeCitationLinkEmailOther DetailsAttachment
6039Ethical approval  [email protected] 378729-(Uploaded-05-12-2019-00-34-17)-Study-related document.pdf
6040Informed 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
SourceTitleYear of PublicationDOI
EmbasePostural control telerehabilitation with a low-cost virtual reality protocol for children with cerebral palsy: Protocol for a clinical trial.2022https://dx.doi.org/10.1101/2022.04.25.22274289
N.B. These documents automatically identified may not have been verified by the study sponsor.