NCT07559162

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

April 23, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

April 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in balance performance assessed by Berg Balance Scale

    Change in 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

Secondary Outcomes (8)

  • Change in dizziness-related disability assessed by 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

    Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment

  • Change in kinesiophobia assessed by Tampa Kinesiophobia Scale

    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

    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

    Baseline, immediately after the 4-week intervention, and 2 months after the end of treatment

  • +3 more secondary outcomes

Study Arms (2)

Ai Chi Group

EXPERIMENTAL

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.

Behavioral: Ai Chi-based exercise programBehavioral: Home-Based Vestibular Rehabilitation

Control Group

ACTIVE COMPARATOR

Participants in this group will receive standard home-based vestibular rehabilitation exercises without additional Ai Chi intervention.

Behavioral: Home-Based Vestibular Rehabilitation

Interventions

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.

Ai Chi Group

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.

Ai Chi GroupControl Group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 28084851BACKGROUND
  • 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.

    PMID: 27490823BACKGROUND
  • 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.

    PMID: 32035856BACKGROUND
  • 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.

    PMID: 22951028BACKGROUND

MeSH Terms

Conditions

DizzinessBenign Paroxysmal Positional VertigoVertigoVestibular Diseases

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments will be performed by a blinded evaluator who is unaware of group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned into two parallel groups: an intervention group receiving Ai Chi in addition to standard home-based vestibular rehabilitation exercises, and a control group receiving standard home-based vestibular rehabilitation exercises only
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Medicine and Rehabilitation Resident

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 30, 2026

Study Start

April 27, 2026

Primary Completion (Estimated)

May 27, 2026

Study Completion (Estimated)

July 27, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04