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| Name | Class |
|---|---|
| Ben-Gurion University of the Negev | OTHER |
| Sheba Medical Center | OTHER_GOV |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App for vestibular rehabilitation | Other | This app is a platform for performing conventional vestibular rehabilitation remotely |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Participants that will meet the following inclusion criteria were recruited to the study:
Exclusion Criteria:
Exclusion criteria for the study group will be as follows:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Wolfovitz, Dr. | Sheba Meical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Hospital | Ramat Gan | Center | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34864777 | Background | 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. | |
| 33774661 |
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| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| 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 |
| 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. |
| 33048219 | 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. |
| 19832817 | 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. |
| 30714985 | 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. |
| 27638071 | 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. |