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Ai Chi-Based Rehabilitation for Peripheral Unilateral Vestibular Dysfunction (AICHI-VR)

4 maja 2026 zaktualizowane przez: Yaren Çelik, Gaziosmanpasa Research and Education Hospital

Contribution of an Ai Chi-Based Rehabilitation Program in Patients With Peripheral Unilateral Vestibular Dysfunction: A Randomized Prospective Single-Blind Study

This study aims to evaluate the effects of an Ai Chi-based rehabilitation program on balance, dizziness severity, and quality of life in patients with unilateral peripheral vestibular hypofunction. Participants will be randomly assigned to either a control group receiving standard home-based vestibular rehabilitation exercises or an intervention group receiving additional Ai Chi sessions. The intervention will be conducted over a 4-week period with a total of 10 sessions under the supervision of a certified therapist.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Unilateral peripheral vestibular hypofunction is a clinical condition characterized by reduced vestibular function due to inner ear or vestibular nerve pathology. It presents with symptoms such as dizziness, imbalance, visual instability, and impaired postural control, significantly affecting functional independence and quality of life. Diagnosis is typically established by the otorhinolaryngology clinic and supported by vestibular function tests such as videonystagmography (VNG) and video head impulse testing (vHIT).

Vestibular rehabilitation is an evidence-based therapeutic approach aimed at promoting central compensation through mechanisms of adaptation, substitution, and habituation. These mechanisms contribute to the improvement of vestibulo-ocular reflex function, postural stability, and overall functional performance.

Ai Chi is an aquatic exercise program derived from Tai Chi and Qi Gong principles, consisting of slow, continuous, and controlled movements coordinated with breathing. The aquatic environment provides unique therapeutic properties such as buoyancy, hydrostatic pressure, and viscosity, allowing safe movement, reducing fall risk, and enhancing proprioceptive and sensory input. These features may support multisensory integration and facilitate central compensation in patients with vestibular dysfunction.

Although aquatic therapy has been increasingly used in rehabilitation, there is limited evidence regarding the effectiveness of Ai Chi specifically in patients with unilateral peripheral vestibular hypofunction. To the best of our knowledge, no randomized controlled study has specifically evaluated the effects of Ai Chi in this patient population.

In this randomized controlled study, participants will be allocated into two groups. Both groups will receive a standardized home-based vestibular rehabilitation program. In addition, the intervention group will participate in supervised Ai Chi sessions conducted in an aquatic environment over a 4-week period, consisting of a total of 10 sessions. All sessions will be delivered by a certified therapist, and adherence will be monitored using exercise logs.

Assessments will be performed at baseline, immediately after the intervention, and during the follow-up period by a blinded evaluator. The findings of this study are expected to contribute to the development of alternative rehabilitation strategies and provide additional evidence for the management of patients with vestibular disorders.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

38

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Age between 18 and 70 years
  • Diagnosis of unilateral peripheral vestibular hypofunction
  • Presence of dizziness symptoms for at least 3 months
  • Ability to participate in Ai Chi and aquatic exercise program
  • Berg Balance Scale score ≥21
  • Willingness to participate in the study

Exclusion Criteria:

  • Inability to complete assessment tests and questionnaires
  • Severe systemic disease that may interfere with exercise participation
  • Central vestibular disorders
  • Berg Balance Scale score ≤20
  • Severe visual or hearing impairment
  • Initiation or change of psychiatric medication within the last 3 weeks
  • Severe cardiopulmonary disease
  • Contraindications to hydrotherapy, including water phobia, behavioral disorders, dyspnea at rest, incontinence, known chlorine allergy, open wounds, acute systemic illness, epilepsy, tracheostomy, permanent drainage devices, immunodeficiency, or known neurological disorders

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Ai Chi Group
Participants in this group will receive an Ai Chi-based aquatic exercise program in addition to standard home-based vestibular rehabilitation exercises. The Ai Chi program will be applied over 4 weeks with a total of 10 sessions under the supervision of a certified therapist.
Behawioralne: Ai Chi-based exercise program
Ai Chi-based exercise program is a structured aquatic therapy approach consisting of slow, continuous, and controlled movements combined with breathing techniques. The program will be conducted in a pool environment over 4 weeks, with a total of 10 sessions delivered as group sessions under the supervision of a certified therapist. The exercises are designed to enhance balance, postural control, proprioceptive input, and multisensory integration, thereby supporting central compensation in patients with vestibular dysfunction.
Behawioralne: Home-Based Vestibular Rehabilitation
Participants will receive a structured home-based vestibular rehabilitation program including gaze stabilization, head movement, balance, and postural control exercises. The program aims to promote vestibulo-ocular reflex adaptation, improve postural stability, and reduce dizziness-related symptoms. Participants will be instructed to perform the exercises regularly, and adherence will be monitored using exercise logs.
Aktywny komparator: Control Group
Participants in this group will receive standard home-based vestibular rehabilitation exercises without additional Ai Chi intervention.
Behawioralne: Home-Based Vestibular Rehabilitation
Participants will receive a structured home-based vestibular rehabilitation program including gaze stabilization, head movement, balance, and postural control exercises. The program aims to promote vestibulo-ocular reflex adaptation, improve postural stability, and reduce dizziness-related symptoms. Participants will be instructed to perform the exercises regularly, and adherence will be monitored using exercise logs.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in balance performance assessed by Berg Balance Scale
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in balance performance will be assessed using the Berg Balance Scale (BBS). The BBS consists of 14 items scored from 0 to 4, with a total score ranging from 0 to 56. Higher scores indicate better balance performance. balance performance will be assessed using the Berg Balance Scale in participants receiving Ai Chi-based exercise program in addition to home-based vestibular rehabilitation, compared with participants receiving home-based vestibular rehabilitation alone.
Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in dizziness-related disability will be assessed using the Dizziness Handicap Inventory (DHI). The DHI consists of 25 items with a total score ranging from 0 to 100. Higher scoredizziness-related disability assessed by Dizziness Handicap Inventory
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in dizziness-related disability will be assessed using the Dizziness Handicap Inventory.
Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in dizziness severity assessed by Vertigo Symptom Scale-Short Form
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in vestibular symptoms will be assessed using the Vestibular Symptoms Scale (VSS). The VSS consists of 15 items evaluating the frequency of vestibular symptoms. Each item is scored from 0 to 4, with a total score ranging from 0 to 60. Higher scores indicate more severe symptoms. dizziness severity will be assessed using the Vertigo Symptom Scale-Short Form.
Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in kinesiophobia assessed by Tampa Kinesiophobia Scale
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK). The TSK consists of 17 items scored from 1 to 4, with total scores ranging from 17 to 68. Higher scores indicate greater fear of movement.
Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in quality of life assessed by Short Form-36
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in quality of life will be assessed using the Short Form-36 Health Survey (SF-36). The SF-36 consists of 8 subscales scored from 0 to 100, with higher scores indicating better health status.
Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in balance confidence assessed by Activities-specific Balance Confidence Scale
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABC). The ABC includes 16 items scored from 0% to 100%, with higher scores indicating greater balance confidence.
Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in functional mobility assessed by Timed Up and Go Test
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in functional mobility will be assessed using the Timed Up and Go Test (TUG). The time required to stand up, walk 3 meters, turn, and sit down is recorded in seconds. Lower times indicate better performance.
Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in tandem balance performance assessed by tandem stance/walking duration
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in dynamic balance will be assessed using tandem walking performance. The duration or number of steps maintained in tandem stance is recorded. Higher performance indicates better balance.
Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in perceived benefit assessed by Vestibular Rehabilitation Benefit Questionnaire
Ramy czasowe: Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment
Change in perceived benefit will be assessed using the Vestibular Rehabilitation Benefit Questionnaire (VRBQ). The questionnaire evaluates symptom severity and quality of life related to vestibular dysfunction. Raw scores are converted to percentage values ranging from 0 to 100. Higher scores indicate greater symptom severity and poorer quality of life.
Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Gaziosmanpasa Research and Education Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

27 kwietnia 2026

Zakończenie podstawowe (Szacowany)

27 maja 2026

Ukończenie studiów (Szacowany)

27 lipca 2026

Daty rejestracji na studia

Pierwszy przesłany

23 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

30 kwietnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 maja 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • AICHI VESTIBULAR RCT 2026

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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