- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07559162
Ai Chi-Based Rehabilitation for Peripheral Unilateral Vestibular Dysfunction (AICHI-VR)
Contribution of an Ai Chi-Based Rehabilitation Program in Patients With Peripheral Unilateral Vestibular Dysfunction: A Randomized Prospective Single-Blind Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yaren Çelik
- Número de teléfono: +90-507-272-7674
- Correo electrónico: celikyaren9797@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
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.
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.
|
|
Comparador activo: Control Group
Participants in this group will receive standard home-based vestibular rehabilitation exercises without additional Ai Chi intervention.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in balance performance assessed by Berg Balance Scale
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Kurt EE, Buyukturan B, Buyukturan O, Erdem HR, Tuncay F. Effects of Ai Chi on balance, quality of life, functional mobility, and motor impairment in patients with Parkinson's disease<sup/> Disabil Rehabil. 2018 Apr;40(7):791-797. doi: 10.1080/09638288.2016.1276972. Epub 2017 Jan 13.
- Covill LG, Utley C, Hochstein C. Comparison of Ai Chi and Impairment-Based Aquatic Therapy for Older Adults With Balance Problems: A Clinical Study. J Geriatr Phys Ther. 2017 Oct/Dec;40(4):204-213. doi: 10.1519/JPT.0000000000000100.
- Pereira CMM, Pinheiro do Vale JS, de Oliveira WP, Pinto DDS, Cal RVR, de Azevedo YJ, Bahmad F Jr. Aquatic physiotherapy: a vestibular rehabilitation option. Braz J Otorhinolaryngol. 2021 Nov-Dec;87(6):649-654. doi: 10.1016/j.bjorl.2019.12.003. Epub 2020 Jan 13.
- Elbar O, Tzedek I, Vered E, Shvarth G, Friger M, Melzer I. A water-based training program that includes perturbation exercises improves speed of voluntary stepping in older adults: a randomized controlled cross-over trial. Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):134-40. doi: 10.1016/j.archger.2012.08.003. Epub 2012 Aug 28.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Otorrinolaringológicas
- Trastornos sensoriales
- Enfermedades del oído
- Enfermedades del laberinto
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Enfermedades Vestibulares
- Vértigo
- Vértigo posicional paroxístico benigno
- Mareo
Otros números de identificación del estudio
- AICHI VESTIBULAR RCT 2026
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .