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Vestibular DisorderNCT05959278

Pilot Feasibility of App-supported Vestibular Rehabilitation

A study testing App for vestibular rehabilitation in people with Vestibular Disorder, run by University of Haifa at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Vestibular Disorder
What is being tested?
App for vestibular rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteIsrael
Study dates
16 Jul 2023to 4 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants that will meet the following inclusion criteria were recruited to the study:
  • between the ages of 18-75;
  • diagnosis of vestibular dysfunction;
  • fluent in Hebrew;
  • own an Android smart-phone

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Sheba Hospital

    Ramat Gan, Center

Other trials in Israel

About this study

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).

Being tested
App for vestibular rehabilitation
Medical subject headings
Vestibular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • App for vestibular rehabilitationOther

    This app is a platform for performing conventional vestibular rehabilitation remotely

Study groups in NCT05959278
Study groupRoleWhat they receive
Group 1 - Vestibular rehabilitation - initially supported by the appExperimentalFirst two and a half weeks - conventional vestibular rehabilitation supported by an app Second two and a half weeks - conventional vestibular rehabilitation without an app
Receives: Other: App for vestibular rehabilitation
Group 2 - Vestibular rehabilitation - initially without the support of the appExperimentalFirst two and a half weeks - conventional vestibular rehabilitation without an app Second two and a half weeks - conventional vestibular rehabilitation supported by an app
Receives: Other: App for vestibular rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

    Measured: After two and a half weeks of using the application

  5. 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.

    Measured: After two and a half weeks of using the application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2023
  2. Study start16 Jul 2023
  3. Primary completion4 Jul 2024
  4. Study completion4 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05959278
Sponsor's protocol ID
SHEBA-23--957622-AW-CTIL
Status last verified
Dec 2024
First submitted
6 Jul 2023
Last updated
9 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34864777

  • 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.

    PubMed 33774661

  • 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.

    PubMed 33048219

  • 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.

    PubMed 19832817

  • 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.

    PubMed 30714985

  • 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.

    PubMed 27638071

Questions about this trial

What is this clinical trial studying?

A study testing App for vestibular rehabilitation in people with Vestibular Disorder, run by University of Haifa at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Instrumented Timed Up and Go Test (iTUG) (Change) (time frame: In each of the measurement sessions - baseline, after two and a half weeks, and after five weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05959278, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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