Trial Review

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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
Date results information 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] 300010 0
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 315536 0
Stability deficits 315537 0
Condition category
Condition code
Physical Medicine / Rehabilitation 313820 313820 0 0
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] 316307 0
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] 322219 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 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] 322219 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] 377763 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).
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] 377763 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] 390205 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] 390205 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
- 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?
No
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
16
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 22173 0
Chile
State/province [1] 22173 0
Talca

Funding & Sponsors
Funding source category [1] 304462 0
Government body
Name [1] 304462 0
Maule Regional Government – Chile
Country [1] 304462 0
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] 304733 0
University
Name [1] 304733 0
Universidad de Talca
Address [1] 304733 0
Calle Cardenal Raúl Silva Henríquez (Ex 1 Poniente) 1441, 4° Piso, Talca
Country [1] 304733 0
Chile

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304896 0
Comité Ético Científico, Universidad de Talca
Ethics committee address [1] 304896 0
Avenida Lircay S/N, Talca, Chile.
Ethics committee country [1] 304896 0
Chile
Date submitted for ethics approval [1] 304896 0
07/08/2018
Approval date [1] 304896 0
26/09/2018
Ethics approval number [1] 304896 0
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 98566 0
Dr Valeska Gatica-Rojas
Address 98566 0
Tele-rehabilitation technology center and Neurosciences in Human Movement, Faculty of Health Sciences, Universidad de Talca, Av. Lircay S/N, Talca, Chile.
Country 98566 0
Chile
Phone 98566 0
+56 71 2418859
Fax 98566 0
Email 98566 0
[email protected]
Contact person for public queries
Name 98567 0
Miss Mariel Mena
Address 98567 0
Universidad de Talca, Av. Lircay S/N, Talca, Chile
Country 98567 0
Chile
Phone 98567 0
+56 71 2414646
Fax 98567 0
Email 98567 0
[email protected]
Contact person for scientific queries
Name 98568 0
Dr Valeska Gatica-Rojas
Address 98568 0
Tele-rehabilitation technology center and Neurosciences in Human Movement, Faculty of Health Sciences, Universidad de Talca, Av. Lircay S/N, Talca, Chile.
Country 98568 0
Chile
Phone 98568 0
+56 71 2418859
Fax 98568 0
Email 98568 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
6106Ethical approval  [email protected] 378877-(Uploaded-10-12-2019-08-35-08)-Study-related document.pdf
6107Informed 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.