Condition category
Ear, Nose and Throat
Date applied
20/01/2020
Date assigned
03/02/2020
Last edited
03/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Vestibular rehabilitation is an important therapeutic option for the treatment of instability and imbalance. Dizziness or instability and imbalance in gait carry a risk of falls.
The prevention of them is an important consideration since they represent an important source of sequelae and therefore influence the patient's quality of life. Different studies have shown that older patients at risk of falling, regardless of gender or age or diagnosis, (whether central, peripheral or gait abnormalities) show a benefit with vestibular rehabilitation.
Vestibular Rehabilitation is developed at home by the patient through exercises with eye, head and body movements, following a prescribed guideline in consultation and delivered in paper format.
The objective of this research is to assess whether a vestibular rehabilitation based on the same exercises but offered through a mobile application with explanations and videos increases adherence to therapy and improves the expected results in the balance and stability of patients.
This study does not imply any extraordinary or different measures than those usually performed.

Who can participate?
Patients with a diagnosis of vestibular dysfunction confirmed and have access to the smartphone or tablet will be recruited to take part in the study

What does the study involve?
The study will have two arms; patients in the treatment arm have access to the mobile application, while patients in the control arm will have access to usual care only ( booklet).

What are the posible benefits and risks participants?
Vestibular rehabilitation based on the same exercises but offered through a mobile application with explanations and videos can increase adherence to therapy and improves the expected results in the balance and stability of patients.

In all vestibular rehabilitation, adverse events are rare, however, there is a possibility that they may experience any of the following symptoms: acute or prolonged pain in the neck, head or ear, feeling of fullness in the ear, deafness or noise in the ear, syncope, double vision and weakness or tingling in the arms or legs. In this case, you are advised to stop the intervention and not continue until you have consulted with the research team. Most of the problems that occur when patients perform the exercises can be remedied by making the exercises more smoothly and slowly.

Where is the study run from?
Otorhinolaryngology Unit, Puerta del Mar University Hospital, Cádiz, Spain.

When is the study starting and how long is it expected to run for?
Recruitment into this study runs from October 2018 until February 2020

Who is funding the study?
Council of Andalusian Health Services (Consejería de Salud, Junta de Andalucia) (Spain)

Who is the main contact?
Antonio Martín
antoniomartinmateos@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Antonio Jesús Martín Mateos

ORCID ID

https://orcid.org/0000-0002-5639-1595

Contact details

Puerta del Mar University Hospital
Ana de Viya
21
Cádiz
11009
Spain
+34 671568420
antonioj.martin.sspa@juntadeandalucia.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PIN-0357-2016

Study information

Scientific title

Effectiveness of a mobile application for vestibular rehabilitation in patients with vestibular disorders: a randomized clinical trial compares mobile application versus booklet based vestibular rehabilitation

Acronym

MhVR

Study hypothesis

1. Vestibular rehabilitation at home through a mobile application is more effective than a home based exercise booklet in reducing symptoms in dizzy patients
2. Mobile application home based vestibular rehabilitation is better than a home based exercise booklet
3. Vestibular rehabilitation at home through a mobile application is more effective than a home based exercise booklet

Ethics approval

Approved 27/10/2016, Research Ethics Committee of Cádiz. (Comité de Ética de la Investigación de Cádiz, Office 817. 8ª Floor, Hospital Universitario Puerta del Mar, Ana de Viya, 21,Cádiz, Spain , 11009; +34 956002005; ceic.hpm.sspa@juntadeandalucia.es), ref: n/a

Study design

Single-centre single-blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Disorders of vestibular function

Intervention

This study compares mobile application versus booklet based vestibular rehabilitation for vestibulopathy.

Control group: receive a booklet that explains Cawthorne-Cooksey (CC) exercises.

Experimental group: receive a mobile application that explains Cawthorne-Cooksey (CC) exercises with videos, with database to register the exercises make by patient. The patient can visualize the database with the exercises performed.

For each study arms: The exercises are classified into 4 progressive levels and each exercise should be performed at least twice a day.

Follow-up for each study arms: Six months.

Randomisation: The randomisation sequence is generated automatically by the Win Epi software . The randomisation algorithm is stratify patients by dizziness severity ( > 60 DHI). Sample randomization and allocation is performed by a researcher who is not involved in the clinical trial. The sequencing remain concealed to the trial team.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Effect of dizziness on daily life measured by the Dizziness Handicap Inventory (DHI) at baseline, after 3 months and after 6 months

Secondary outcome measures

1. Dizziness measured using a single item measure of subjective improvement. This asks patients to indicate whether they had felt better, same or worse with regard to their dizziness symptoms than at baseline
2. Demographic characteristics, including age, sex ,clinical and topographic diagnosis

Overall trial start date

01/01/2018

Overall trial end date

01/03/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Diagnosis of vestibular disease according to revised Society Barany criteria
3. Availability of Smarthphone or Tablet system android or ios
4. Sign informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 84 patients, 42 in each study group.

Participant exclusion criteria

1. Non-vestibular causes of dizziness
2. Medical contraindication for performing head movement exercises (such as diseases severe cervical)
3. Severe comorbidity (such as disabling neurological diseases)

Recruitment start date

01/10/2018

Recruitment end date

01/09/2019

Locations

Countries of recruitment

Spain

Trial participating centre

Puerta del Mar University Hospital
Otorhinolaryngology Unit Ana de Viya, 21
Cádiz
11012
Spain

Sponsor information

Organisation

Fundación para la Gestión de la Investigación Biomedica de Cádiz

Sponsor details

Ana de Viya
21
Cádiz
11012
Spain
+34 956 245 018 / +34 956 245 019
fundacion.cadiz@juntadeandalucia.es

Sponsor type

Research organisation

Website

http://www.juntadeandalucia.es/index.html

Funders

Funder type

Government

Funder name

Council of Andalusian Health Services (Consejería de Salud, Junta de Andalucia) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Dissemination of the research results within the clinical and scientific community, through papers published in clinical journals and presentations at conferences.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Will individual participant data be available (including data dictionaries)? Yes
What data in particular will be shared? All of the individual participant data collected during the trial, after deidentification.
What other documents will be available? Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code
When will data be available (start and end dates)? Immediately following publication. No end date.
With whom? Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose.
For what types of analyses? Any purpose
By what mechanism will data be made available? Data are available indefinitely (Link to be provided).

Intention to publish date

31/10/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/02/2020: Trial’s existence confirmed by Research Ethics Committee of Cádiz