Pilot Feasibility of App-supported Vestibular Rehabilitation

NCT ID: NCT05959278

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-16

Study Completion Date

2024-07-04

Brief Summary

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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).

Detailed Description

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Conditions

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Vestibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1 - Vestibular rehabilitation - initially supported by the app

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

Group Type EXPERIMENTAL

App for vestibular rehabilitation

Intervention Type OTHER

This app is a platform for performing conventional vestibular rehabilitation remotely

Group 2 - Vestibular rehabilitation - initially without the support of the app

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

Group Type EXPERIMENTAL

App for vestibular rehabilitation

Intervention Type OTHER

This app is a platform for performing conventional vestibular rehabilitation remotely

Interventions

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App for vestibular rehabilitation

This app is a platform for performing conventional vestibular rehabilitation remotely

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ben-Gurion University of the Negev

OTHER

Sponsor Role collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

University of Haifa

OTHER

Sponsor Role lead

Responsible Party

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Yoav Gimon

Head of the dizziness clinic, Sheba Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amit Wolfovitz, Dr.

Role: PRINCIPAL_INVESTIGATOR

Sheba Meical Center

Locations

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Sheba Hospital

Ramat Gan, Center, Israel

Site Status

Countries

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Israel

References

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Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382.

Reference Type BACKGROUND
PMID: 34864777 (View on PubMed)

Kim KJ, Gimmon Y, Millar J, Brewer K, Serrador J, Schubert MC. The Instrumented Timed "Up & Go" Test Distinguishes Turning Characteristics in Vestibular Hypofunction. Phys Ther. 2021 Jul 1;101(7):pzab103. doi: 10.1093/ptj/pzab103.

Reference Type BACKGROUND
PMID: 33774661 (View on PubMed)

Meldrum D, Burrows L, Cakrt O, Kerkeni H, Lopez C, Tjernstrom F, Vereeck L, Zur O, Jahn K. Vestibular rehabilitation in Europe: a survey of clinical and research practice. J Neurol. 2020 Dec;267(Suppl 1):24-35. doi: 10.1007/s00415-020-10228-4. Epub 2020 Oct 13.

Reference Type BACKGROUND
PMID: 33048219 (View on PubMed)

Polensek SH, Tusa RJ, Sterk CE. The challenges of managing vestibular disorders: a qualitative study of clinicians' experiences associated with low referral rates for vestibular rehabilitation. Int J Clin Pract. 2009 Nov;63(11):1604-12. doi: 10.1111/j.1742-1241.2009.02104.x.

Reference Type BACKGROUND
PMID: 19832817 (View on PubMed)

Rosiak O, Krajewski K, Woszczak M, Jozefowicz-Korczynska M. Evaluation of the effectiveness of a Virtual Reality-based exercise program for Unilateral Peripheral Vestibular Deficit. J Vestib Res. 2018;28(5-6):409-415. doi: 10.3233/VES-180647.

Reference Type BACKGROUND
PMID: 30714985 (View on PubMed)

Whitney SL, Alghwiri AA, Alghadir A. An overview of vestibular rehabilitation. Handb Clin Neurol. 2016;137:187-205. doi: 10.1016/B978-0-444-63437-5.00013-3.

Reference Type BACKGROUND
PMID: 27638071 (View on PubMed)

Other Identifiers

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SHEBA-23--957622-AW-CTIL

Identifier Type: -

Identifier Source: org_study_id