Clinical trial NCT05959278: Pilot Feasibility of App-supported Vestibular Rehabilitation
Official title: Pilot Feasibility of App-supported Vestibular Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disorder
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
name: Sheba Medical Center
First posted: 2023-07-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Instrumented Timed Up and Go Test (iTUG) (Change)
timeFrame: In each of the measurement sessions - baseline, after two and a half weeks, and after five weeks
measure: State-Trait Anxiety Inventory (STAI) (Change)
timeFrame: In each of the measurement sessions - baseline, after two and a half weeks, and after five weeks
measure: Dizziness Handicap Inventory (DHI) (Change)
timeFrame: In each of the measurement sessions - baseline, after two and a half weeks, and after five weeks
measure: Custom-made questionnaire
timeFrame: After two and a half weeks of using the application
measure: User Satisfaction Evaluation Questionnaire (USEQ)
timeFrame: After two and a half weeks of using the application
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Hospital
state: Center
Study officials:
affiliation: Sheba Meical Center
name: Amit Wolfovitz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.