NCT07587554

Brief Summary

Unilateral Peripheral Vestibular Dysfunction (UPVD) causes dizziness, imbalance, vertigo, and reduced quality of life. Conventional Vestibular Rehabilitation Therapy (cVRT) is effective, while WiiFit-based virtual reality training may further enhance motivation and neuroplasticity. This study aims to compare WiiFit-based training with conventional rehabilitation in improving balance and reducing dizziness in UPVD patients. A randomized controlled trial will include participants aged 18-65 meeting specific inclusion and exclusion criteria. Participants will be randomly divided into two groups: Group A receiving conventional therapy (40 minutes, 3 sessions/week) and Group B receiving WiiFit-based exercises for 4 weeks. Outcomes will be assessed using DHI, Mini-BESTest, and VADL before and after intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 8, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

Vestibular rehabilitationWii FitBalance trainingDizzinessUnilateral peripheral vestibular dysfunctionVestibular disordersPostural balanceBalance impairmentVirtual reality rehabilitationRehabilitation therapy

Outcome Measures

Primary Outcomes (2)

  • Perceived effects of dizziness

    Dizziness Handicap Inventory (DHI) is a 25-item self-administered questionnaire intended to assess the perceived effects of dizziness on an individual's everyday activities. Values vary from 0 (no handicap) to 100 (highest handicap), with increasing values signifying more incapacity interpretation: 16-34- mild impairment 36-52- moderate impairment 52+ - severe impairment

    4 weeks

  • Dynamic Balance

    The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a performance-based instrument designed to evaluate dynamic balance. The assessment comprises 14 items rated on a 3-point scale (0 = severe impairment to 2 = normal), yielding a maximum total score of 28. interpretation: 28- normal 20-22- minor balance impairment Below 20- significant fall risk

    4 weeks

Secondary Outcomes (1)

  • disability in adults with vestibular dysfunction

    4 weeks

Study Arms (2)

Vestibular Rehabilitation Therapy

ACTIVE COMPARATOR

Participants in the control group will undergo standard vestibular rehabilitation therapy, which includes gaze stabilization, habituation, and balance retraining activities. The program will consist of three sessions weekly, spanning four consecutive weeks, with each session lasting around 30 to 40 minutes. Exercises will start in a sitting posture and gradually move to standing and dynamic balancing activities, customized to the patient's tolerance and safety. Following exercises will be administered: Week 1: 1. Romberg (EO → EC) 2. Foam surface standing (eyes open) 3. VOR x1 (seated) 3 sets/ 10 reps Week 2: 1. Standing VOR x1 2. Tandem walking 3. Walking with head turns 3 sets/10 reps Week 3: 1. Side shuffle with head turns 2. Ball Toss with Head Turns 3. Bowling with ball 3 sets/10 reps Week 4: 1. Multi-directional stepping 2. TUG with Head Turns 3. VOR x1/x2 While Walking 4. Dual-task walking 3 sets/10 reps

Procedure: Vestibular Rehabilitation Therapy

Wii Fit Vestibular Training

EXPERIMENTAL

Participants in the experimental group will undergo vestibular training using the Wii Fit on the Nintendo Wii balance platform. Sessions will include interactive balance tasks targeting postural control, coordination, and visual-vestibular integration. Training will be conducted three times per week for four weeks, with each session lasting approximately 30 minutes and progressively advancing from basic to more complex activities based on participant performance and safety. Real-time feedback from the Wii system will be used to enhance motivation, adherence, and engagement. Week 1 will include Table Tilt (basic) and Soccer Heading (10 min each with 5 min warm-up and 5 min cool-down). Week 2 will include Balance Bubble, Bowling, and Ski Slalom (slow), 10 min each with warm-up and cool-down. Week 3 will include Obstacle Course (basic), Table Tilt (advanced), and Penguin Slide, 10 min each. Week 4 will involve a combination of all games, 5 min each with 2-3 min rest intervals.

Procedure: Wiifit Vestibular Training

Interventions

Participants in the control group will undergo standard vestibular rehabilitation therapy, which includes gaze stabilization, habituation, and balance retraining activities. The program will consist of three sessions weekly, spanning four consecutive weeks, with each session lasting around 30 to 40 minutes. Exercises will start in a sitting posture and gradually move to standing and dynamic balancing activities, customized to the patient's tolerance and safety. To mitigate danger, sessions will occur in a peaceful, organized environment with supportive aids (e.g. chair or wall) accessible. Safety standards will encompass a pre-session fall risk assessment and therapist oversight, while any adverse events will be recorded and addressed under physician consultation.

Vestibular Rehabilitation Therapy

Participants in the experimental group will engage in vestibular training via the Wii Fit on the Nintendo Wii balancing platform. Sessions will include interactive balancing activities aimed at challenging postural control, coordination, and visual-vestibular integration. Training will consist of three sessions each week over four weeks, with each session lasting about 30 minutes, progressively increasing from fundamental to more intricate activities based on participant performance and safety considerations. Real-time feedback from the Wii system will be utilized to improve motivation, adherence, and task engagement. Safety measures will encompass therapist oversight at all times, the prevention of abrupt head movements or visual distractions during initial phases, and the delivery of both written and vocal directives to avert falls.

Wii Fit Vestibular Training

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18-65 years
  • Diagnosed with UPVD (confirmed via Positive Head Thrust Test)
  • Experiencing persistent dizziness or imbalance for \>4 weeks after acute onset
  • Able to stand and walk independently
  • VSS total score \>12

You may not qualify if:

  • Central vestibular disorders (e.g., stroke, multiple sclerosis)
  • Active BPPV (confirmed by Dix-Hallpike Test)
  • Severe visual or MSK impairments affecting balance
  • History of epileptic seizures or motion sickness triggered by video games
  • Participation in other vestibular rehab programs during study period -- Diagnosed with severe cervical spine disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Vestibular DiseasesVertigoDizziness

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSensation Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 14, 2026

Study Start

November 18, 2025

Primary Completion

April 29, 2026

Study Completion

April 29, 2026

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations