Pilot Feasibility of App-supported Vestibular Rehabilitation

Vestibular Disorder Clinical Trial

Official title:

Pilot Feasibility of App-supported Vestibular Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959278
• Other study ID #: SHEBA-23--957622-AW-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2023
• Est. completion date: May 30, 2025

Study information

• Verified date: March 2024
• Source: University of Haifa
• Contact: Azriel Kaplan
• Phone: +972546387098
• Email: azrielk[@]post.bgu.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vestibular Diseases
• Vestibular Disorder

Intervention

Other:
• App for vestibular rehabilitation
This app is a platform for performing conventional vestibular rehabilitation remotely

Locations

Country	Name	City	State
Israel	Sheba Hospital	Ramat Gan	Center

Sponsors (3)

Lead Sponsor	Collaborator
University of Haifa	Ben-Gurion University of the Negev, Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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