NCT06563076

Brief Summary

This study aimed to evaluate the effectiveness of the vestibular rehabilitation program applied to patients with chronic unilateral vestibular hypofunction and the vestibular electrical stimulation applied to the trapezius muscles and cervical paravertebral muscles along with the rehabilitation program.

Trial Health

87
On Track

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
Completed

Started Jan 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 17, 2024

Last Update Submit

August 19, 2024

Conditions

Vestibular DiseasesVestibular DisorderVestibular Vertigo

Keywords

VertigoRehabilitationTENS

Outcome Measures

Primary Outcomes (1)

  • Dizziness Handicap Inventory

    'Dizziness Handicap Inventory (DHI)' consists of 25 items that determine the functional and sensory consequences of vestibular system diseases as well as the factors that aggravate dizziness and balance disorders. Questions 1, 4, 8, 11, 13, 17 and 25 of the scale are structured to measure physical disability; questions 2, 9, 10, 15, 18, 20, 21, 22 and 23 are structured to measure emotional disability; questions 3, 5, 6, 7, 12, 14, 16, 19 and 24 are structured to measure functional disability. Each question is scored as yes (4 points), no (0 points) and sometimes (2 points). The level of disability can be categorized according to the scale: 16-34 points = mild disability; 36-52 points = moderate disability; 54+ points = severe disability

    Baseline and after 4 weeks

Secondary Outcomes (7)

  • Dizziness Severity Visual Analog Scale

    Baseline and after 4 weeks

  • Timed Up and Go Test

    Baseline and after 4 weeks

  • Berg Balance Score

    Baseline and after 4 weeks

  • Activity Specific Balance and Confidence Scale

    Baseline and after 4 weeks

  • Beck Depression Inventory

    Baseline and after 4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Vestibular Rehabilitation Group

ACTIVE COMPARATOR

underwent vestibular rehabilitation program

Other: Vestibular Rehabilitation

Vestibular Rehabilitation and Vestibular Electrical Stimulation Group

ACTIVE COMPARATOR

underwent vestibular electrical stimulation (VES) in addition to the supervised vestibular rehabilitation program.

Other: Vestibular RehabilitationOther: Vestibular Electrical Stimulation

Interventions

Vestibular RehabilitationOTHER

supervised vestibular rehabilitation program

Vestibular Rehabilitation GroupVestibular Rehabilitation and Vestibular Electrical Stimulation Group
Vestibular Electrical StimulationOTHER

80 Hz high frequency transcutaneous vestibular electrical stimulation (VES)

Vestibular Rehabilitation and Vestibular Electrical Stimulation Group

Eligibility Criteria

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

You may qualify if:

  • Being between the ages of 18-65
  • Patients who were evaluated by a Neurologist, Physical Medicine and Rehabilitation Specialist and otorhinolaryngologist and diagnosed with chronic unilateral vestibular hypofunction and have findings of chronic unilateral vestibular hypofunction
  • Patients whose VOR gain for any unilateral semicircular canal based on vHIT test is below 0.7
  • Patients who volunteered to participate in the study and signed the consent forms

You may not qualify if:

  • Existing neurological or mental disorders
  • Patients using vestibulosuppressant drugs
  • Stroke, head trauma and other neurological diseases
  • Patients with a history of brain surgery
  • Patients with severely limited neck joint range of motion (those with a limitation of 45 degrees or more)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vestibular DiseasesVertigo

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bilal Burak Bayraklı, M.D

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

  • Ömer Kuzu, M.D

    Ankara City Hospital Bilkent

    STUDY CHAIR

  • Canan Çelik, Professor

    Ankara City Hospital Bilkent

    STUDY DIRECTOR

  • Özlem Öztürk Tan, M.D

    Ankara City Hospital Bilkent

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Medical Doctor

Study Record Dates

First Submitted

August 17, 2024

First Posted

August 20, 2024

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)