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Trial registered on ANZCTR

Registration number

ACTRN12621001380886

Ethics application status

Approved

Date submitted

10/01/2021

Date registered

11/10/2021

Date last updated

11/10/2021

Date data sharing statement initially provided

11/10/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Telerehabilitation with virtual reality in older adults.

Scientific title

Implementation of an exercise program with virtual reality via telerehabilitation for older adults

Secondary ID [1]

Authority, Maule Regional Government - Chile
ID, 30.481.923-0

Universal Trial Number (UTN)

U1111-1244-9649

Trial acronym

TvrOA, Telerehabilitation virtual reality in Older Adults.

Linked study record

Health condition

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

Postural Instability

Stability deficits

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Clinical trial parallel in older adults. 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-group” performed by older adult properly trained for 6 months in W-t. An older adult trained in W-t will be the therapist of his older adult peers which belong to a geriatrics Club, a physical space close to their homes that seeks to provide recreational and sports activities for older adults who attend daily. The elderly therapist will be guided remotely from the telerehabilitation center of the Universidad de Talca.
W-t will be have for 6 weeks of training, which will have at a frequency of three times per week reaching 18 sessions in total and four weeks of follow-up in the older adults. Each participants will execute three series of exercise with manual guidance and verbal instructions for the first 3 weeks and only verbal instructions by an older adult therapist in the following weeks. The protocol has three series of exercises and activates postural balance in the three planes of motion: sagittal, frontal and transversal. The games –Snowboard, Penguin Slide and Super Hula Hoop- will be used for the first two series of exercise, and the yoga game will be used for the third series. In the first series of exercise, the older adults stand with their arms and hands at their sides in the relaxed manner. In the second series of exercises, each game will be repeated in the standing position with their hands on their waists. Between the first and the second series of exercises, there will be a one to two minute break, where the participants will sit on a chair until they had recovered. The third series of exercises will consist of keeping their posture as relaxed as possible during the yoga game with their eyes open and then repeating it with their eyes closed.
W-t will consist of a virtual reality training session using the Nintendo Wii balance board console for 25 min each session. W-t is based on previous studies. So, the strategies used to monitor adherence to the intervention have: session attendance checklists in an excell and direct observation by study personnel (physioterapist and elderly therapist).

Intervention code [1]

Rehabilitation

Comparator / control treatment

A virtual reality-based exercise protocol using Wii therapy (W-t) with Nintendo Wii balance board this group (face to face version, F/F) will perform only a physiotherapist towards the older adult during six weeks of training and four weeks of follow-up in this population. The exercise protocol is the same as for the exposure group, the difference is that the older adult is face to face with the physiotherapist in the Tele-rehabilitation technology center and Neurosciences in Human Movement, Universidad de Talca, Talca, Chile.

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 eight conditions for 60 seconds each: (i) eyes open (EO), (ii) eyes closed (EC), (iii) then with EO and EC mediolateral displacement of body guided by auditory stimuli (sound) at a frequency of 30Hz (iv), and subsequently 60Hz so much with EO (v) and EC (vi), and finally mediolateral and anteroposterior displacement of body with virtual environment (vii and viii, respectively). Postural balance evaluation will be complete within 30 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).
Clinical measurements: Single-leg station (seconds); Time Up and Go (meters/seconds); Barthel index (variable in number) and Tinneti scale (variable in number), will be complete within 20 minutes.

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

- Older adults volunteers.
- Occasional or permanent corrected lens wear.
- Mini Mental State Examination (MMSE) score of over 17 points.
- Older adults no falls in the last 12 months.

Minimum age

65 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Vestibular impairment.
- Participants with access to a Nintendo Wii at home or execution of other physical therapies.

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 changes in the effects postural balance of W-t face to face versus remote version at six weeks. Based on data from earlier studies (Gatica V. et al., 2010; Gatica-Rojas, V., 2016; Gatica-Rojas et al., 2019), we propose a difference equal to or greater than 1.5 units. We also considered a standard deviation of 1,1 cm2, a significance alpha level of 0.05, 80% statistical power, and with an allowance for 5% attrition, we required a minimum of 8 participants in each group (total sample of 16).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

28/10/2019

Date of last participant enrolment

Anticipated

Actual

7/02/2020

Date of last data collection

Anticipated

Actual

22/05/2020

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 City, Maule Región, Chile

Country [1]

Chile

Primary sponsor type

Government body

Name

Maule Regional Government – Chile

Address

Calle 1 Nte. 731, Talca City, 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 older adults. A clinical trial design with two-arm and parallel whose objective will be to compare the effectiveness in improvement postural balance of face-to-face Wii therapy (physiotherapist with the patient) versus remote (elderly therapist, which was trained for 6 months in W-t by a physiotherapist). Wii therapy face to face versus remote version are equivalent in their effects for the postural balance in this population.

Trial website

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

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

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
6106	Ethical approval			[email protected]		378877-(Uploaded-10-12-2019-08-35-08)-Study-related document.pdf
6107	Informed consent form			[email protected]		378877-(Uploaded-10-12-2019-08-38-19)-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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically