Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

4. mai 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

38

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in balance performance assessed by Berg Balance Scale
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

27. april 2026

Primær fullføring (Antatt)

27. mai 2026

Studiet fullført (Antatt)

27. juli 2026

Datoer for studieregistrering

Først innsendt

23. april 2026

Først innsendt som oppfylte QC-kriteriene

23. april 2026

Først lagt ut (Faktiske)

30. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere