Pilot Feasibility of App-supported Vestibular Rehabilitation

NCT05959278 | Completed

• 1 other identifier: SHEBA-23--957622-AW-CTIL
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Vestibular Disorder

Outcome Measures

Primary Outcomes (5)

• Instrumented Timed Up and Go Test (iTUG) (Change)

  The Timed Up and Go Test (TUG) examine functional balance The investigators will use the Instrumented Timed Up and Go Test (iTUG), for a combination of qualitative and quantitative assessment for this test. For the measurement, the investigators will use Opal (APDM) sensors. Measurements will be repeated three times to determine whether any changes have occurred during the rehabilitation process.

  In each of the measurement sessions - baseline, after two and a half weeks, and after five weeks

• State-Trait Anxiety Inventory (STAI) (Change)

  The STAI is a self-reported questionnaire designed to examine a person's general and current anxiety levels. The investigators will use this questionnaire to better distinguish between the participant's general and momentary anxiety to assess vestibular rehabilitation's effect on anxiety levels. This is a questionnaire with a numerical score between 40-160, a higher score indicates more anxiety. Measurements will be repeated three times to determine whether any changes have occurred during the rehabilitation process.

  In each of the measurement sessions - baseline, after two and a half weeks, and after five weeks

• Dizziness Handicap Inventory (DHI) (Change)

  The DHI is a 25-items questionnaire designed to assess the impact of dizziness on everyday life in people with vestibular disorders. This is a questionnaire with a numerical score between 0-100; a higher score indicates a higher level of handicap. Measurements will be repeated three times to determine whether any changes have occurred during the rehabilitation process.

  In each of the measurement sessions - baseline, after two and a half weeks, and after five weeks

• Custom-made questionnaire

  The questionnaire includes questions regarding the user's experience with the application. The investigators will use the questionnaire to get the participants' feedback on using the app and to examine the feasibility of using the app in vestibular rehabilitation. This questionnaire mostly includes open-ended questions in free text and a part that includes questions with a numerical rating between 5-30. A higher score indicates a better user experience in the app.

  After two and a half weeks of using the application

• User Satisfaction Evaluation Questionnaire (USEQ)

  The investigators will use the questionnaire to get the participants' feedback on the use of the app, and to examine the feasibility of using the app in vestibular rehabilitation This is a questionnaire with a numerical score between 5-30; a higher score indicates a higher satisfaction level.

  After two and a half weeks of using the application

Study Arms (2)

Group 1 - Vestibular rehabilitation - initially supported by the app

EXPERIMENTAL

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

Other: App for vestibular rehabilitation

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

EXPERIMENTAL

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

Other: App for vestibular rehabilitation

Interventions

App for vestibular rehabilitation OTHER

This app is a platform for performing conventional vestibular rehabilitation remotely

Group 1 - Vestibular rehabilitation - initially supported by the app; Group 2 - Vestibular rehabilitation - initially without the support of the app

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the ages of 18-75;
• diagnosis of vestibular dysfunction;
• fluent in Hebrew;
• own an Android smart-phone

You may not qualify if:

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

Sponsors & Collaborators

• University of Haifa: lead
• Ben-Gurion University of the Negev: collaborator
• Sheba Medical Center: collaborator

Study Sites (1)

Sheba Hospital

Ramat Gan, Center, Israel

Location

Related Publications (6)

• 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.

  PMID: 34864777 BACKGROUND

• 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.

  PMID: 33774661 BACKGROUND

• 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.

  PMID: 33048219 BACKGROUND

• 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.

  PMID: 19832817 BACKGROUND

• 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.

  PMID: 30714985 BACKGROUND

• 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.

  PMID: 27638071 BACKGROUND

MeSH Terms

Conditions

Vestibular Diseases

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Amit Wolfovitz, Dr.

  Sheba Meical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the dizziness clinic, Sheba Hospital

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 25, 2023
• Study Start: July 16, 2023
• Primary Completion: July 4, 2024
• Study Completion: July 4, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

IL (1)