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Pilot Feasibility of App-supported Vestibular Rehabilitation

U

University of Haifa

Status

Completed

Conditions

Vestibular Disorder

Treatments

Other: App for vestibular rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT05959278
SHEBA-23--957622-AW-CTIL

Details and patient eligibility

About

The primary goal of the study is to examine the feasibility of accompanying vestibular practice supported by a phone app for vestibular rehabilitation. Feasibility will be established using the following parameters: (1) the User Satisfaction Evaluation Questionnaire (USEQ) (2) a custom-made questionnaire to collect feedback from participants, and (3) compliance measurements derived from app usage. The secondary goal of the study is to examine the effect of practice supported by the app on balance and anxiety indices. These will be measured using the following parameters: (1) Instrumented Timed Up and Go Test (iTUG), (2) Dizziness Handicap Inventory (DHI), (3) State-Trait Anxiety Inventory (STAI). The third goal is to assess the correlation between balance function (iTUG) and anxiety (STAI).

A randomized crossover pilot study will be conducted with 24 participants. During the study, each group will undergo two and a half weeks of conventional vestibular rehabilitation and two and a half weeks of app-supported vestibular rehabilitation. Measurement sessions will be conducted at three-time points: upon enrollment in the study (T0), after two and a half weeks (T1), and at the end of the study (T2).

Enrollment

26 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants that will meet the following inclusion criteria were recruited to the study:

  1. between the ages of 18-75;
  2. diagnosis of vestibular dysfunction;
  3. fluent in Hebrew;
  4. own an Android smart-phone

Exclusion criteria

Exclusion criteria for the study group will be as follows:

  1. a medical condition that prevents participant from performing home vestibular rehabilitation practice - such as orthopedic, neurological, cardiac, visual impairment;
  2. individuals with dizziness who already have been given a home vestibular rehabilitation exercise program;
  3. diagnosis of central vestibular disorder due to brain structural damage.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

26 participants in 2 patient groups

Group 1 - Vestibular rehabilitation - initially supported by the app
Experimental group
Description:
First two and a half weeks - conventional vestibular rehabilitation supported by an app Second two and a half weeks - conventional vestibular rehabilitation without an app
Treatment:
Other: App for vestibular rehabilitation
Group 2 - Vestibular rehabilitation - initially without the support of the app
Experimental group
Description:
First two and a half weeks - conventional vestibular rehabilitation without an app Second two and a half weeks - conventional vestibular rehabilitation supported by an app
Treatment:
Other: App for vestibular rehabilitation

Trial contacts and locations

1

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Central trial contact

Azriel Kaplan

Data sourced from clinicaltrials.gov

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