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Идёт набор NCT06222450

Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI

Без фазы С лечением Mild Traumatic Brain Injury Dizziness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Vestibular Rehabilitation Therapy (VRT).
Кому может быть актуально
Состояния в реестре: Mild Traumatic Brain Injury, Dizziness. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Rock Steady: A Mobile, Gamified Vestibular Rehabilitation Therapy App for Adults With Dizziness Related to Mild Traumatic Brain Injury

Обзор

The goal of this clinical trial is to compare outcomes for standard vestibular rehabilitation home program to a digital vestibular rehabilitation home program in adults with dizziness related to mild traumatic brain injury (mTBI). The main question is whether participants who use the digital format of vestibular rehabilitation improve to a greater extent at discharge than those who use the standard format. Participants will undergo a customized vestibular rehabilitation home exercise program per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training under the supervision of a physical therapist. Participants will complete the gaze stabilization and habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks. Participants will be tested before and after the 4-week intervention. At the initial session, the researcher will perform standard clinical tests of the inner ear balance system. Also at the initial session, the researcher will perform standard clinical tests of balance and walking and questionnaires about the impact of dizziness on daily activities. At the final session, the researcher will repeat the tests of balance and walking and questionnaires. Three months after completing the intervention participants will complete an online questionnaire about the impact of dizziness on daily activities.

Подробное описание

A single blind randomized controlled trial (RCT) will be performed with pre- and post-treatment assessment and a 3-month follow-up assessment. Study groups are defined by the method that the home exercise vestibular rehabilitation therapy (VRT) program is provided: Group 1 will receive standard vestibular rehabilitation therapy (S-VRT) home program, while Group 2 will receive a digital vestibular rehabilitation therapy (D-VRT) home program using the Health in Motion platform. Sixty-eight adults (+10% for attrition) with sub-acute (2 weeks-3 months) or chronic dizziness (\> 3 months) related to mTBI will be recruited and enrolled in the study. We will use a randomized block design to assure equal allocation of symptom severity to the intervention groups. Random assignment will be made using SPSS random number function. The research coordinator at each study site will create sealed study envelopes with the random study identification number that contains group assignment. In order to instruct the participant in the appropriate exercise intervention, the treating physical therapist will receive an envelope (in consecutive order) once a subject has consented to participate in the study. This study will incorporate a single blind research design, so that the researcher performing clinical balance and gait assessments will be blinded to group assignment. It is not possible to blind the treating therapist or participants.

During the pre-test session, the researcher will perform a standard vestibular evaluation including tests of balance and walking as well as questionnaires about dizziness impact on activities, balance confidence, motion sensitivity, and disability.

The treating clinician will create and provide a customized VRT home exercise program (HEP) per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training. Gaze stabilization exercises involve head movement while maintaining fixation on a target which may be stationary or moving. Habituation exercises are chosen based on movements (of self or the visual environment) that provoke symptoms and the participant performs several repetitions of motions that cause mild to moderate symptoms. Balance and gait exercises are chosen based on identified impairments and limitations and are performed under challenging sensory and dynamic conditions to optimize balance. General conditioning, such as a customized graduated walking program for endurance will be included.

All participants will receive verbal instructions (in Health in Motion the text instruction is accompanied with voice over), demonstration of, and feedback on, accurate performance of the gaze stabilization/habituation HEP per group assignment. The S-VRT group will only receive these instructions and feedback at the weekly clinic visit from the supervising clinician. The D-VRT group will receive exercise instructions and demonstration via the Rock Steady app the first time using a game and as requested thereafter. The supervising clinician will evaluate the participant's ability to accurately perform the exercises at each follow-up visit (1x/week) and will provide additional training/feedback as needed for both S-VRT and D-VRT groups.

All participants will be instructed to complete the gaze stabilization/habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks. All participants will use a paper exercise log to record the performance of the HEP, regardless of group assignment. After completing the 4-week intervention, participants will be offered the option to continue using their current method or try the alternate method for the 3- month maintenance phase. After the 3-month maintenance phase, participants will complete the questionnaire about dizziness impact on daily activities.

Вмешательства

  • Поведенческое Vestibular Rehabilitation Therapy (VRT)
    customized VRT home exercise program per standard of care, includes gaze stabilization, habituation, balance and gait exercises, and endurance training

Первичные конечные точки

  • Change from baseline in Dizziness on the Dizziness Handicap Inventory (DHI) at week four and week 12 [Срок оценки: baseline, week 4, week 12]
Вторичные конечные точки (7)
  • Change from baseline in modified Clinical Test of Sensory Interaction and Balance (mCTSIB) at week 4 [Срок оценки: baseline, week 4]
  • Change from baseline in Functional Gait Assessment (FGA) at week 4 [Срок оценки: baseline, week 4]
  • Change from baseline in 10 Meter Walk Test (10MWT) at week 4 [Срок оценки: baseline, week 4]
  • Change from baseline in Visual Analogue Scales (VAS) at week 4 [Срок оценки: baseline, week 4]
  • Change from baseline in Activities-specific Balance Confidence scale (ABC) at week 4 [Срок оценки: baseline, week 4]
  • Change from baseline in Disability Rating Scale (DRS) at week 4 [Срок оценки: baseline, week 4]
  • Change from baseline in modified Motion Sensitivity Test (mMST) at week 4 [Срок оценки: baseline, week 4]

Критерии участия

Критерии включения

  • at least 18 years of age,
  • diagnosis of mTBI,
  • documented dizziness (total DHI score ≥ 16) and/or imbalance (total functional gait assessment score < 23/30 or < age-referenced norms)

Критерии исключения

  • severe neurological disease (e.g., Parkinson's disease, neuropathy),
  • moderate to severe cognitive impairment (< 23/30 on the Montreal Cognitive Assessment),
  • significant orthopedic issues that would impact mobility or ability to perform gaze stabilization exercises (e.g., significant cervical dysfunction or pain),
  • vision impairment (best-corrected visual acuity worse than 20/40 in the better eye), and
  • severe depression/anxiety (≥ 9 on the 4-item Patient health Questionnaire)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • James A Haley VA Hospital — Tampa
  • Duke University School of Medicine — Durham
  • James H Quillen VAMC — Mountain Home

Публикации

  • Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011. PMID 2317323
  • Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18. PMID 15449976
  • Walker ML, Austin AG, Banke GM, Foxx SR, Gaetano L, Gardner LA, McElhiney J, Morris K, Penn L. Reference group data for the functional gait assessment. Phys Ther. 2007 Nov;87(11):1468-77. doi: 10.2522/ptj.20060344. Epub 2007 Sep 4. PMID 17785375
  • Bohannon RW, Williams Andrews A. Normal walking speed: a descriptive meta-analysis. Physiotherapy. 2011 Sep;97(3):182-9. doi: 10.1016/j.physio.2010.12.004. Epub 2011 May 11. PMID 21820535
  • Hall CD, Herdman SJ. Reliability of clinical measures used to assess patients with peripheral vestibular disorders. J Neurol Phys Ther. 2006 Jun;30(2):74-81. doi: 10.1097/01.npt.0000282571.55673.ed. PMID 16796772
  • Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28. PMID 7814786
  • Shepard NT, Telian SA, Smith-Wheelock M. Habituation and balance retraining therapy. A retrospective review. Neurol Clin. 1990 May;8(2):459-75. PMID 2359384
  • Heusel-Gillig L, Santucci V, Hall CD. Development and Validation of the Modified Motion Sensitivity Test. Otol Neurotol. 2022 Sep 1;43(8):944-949. doi: 10.1097/MAO.0000000000003641. PMID 35970158

Идентификаторы

NCT: NCT06222450 · TP210512

Первоисточники (государственные реестры)

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