NCT04687371

Brief Summary

The aim of this study was to investigate the effect of proprioceptive vestibular rehabilitation on balance, functional mobility, posture, sensory profile and quality of life in patients with vertigo due to peripheral vestibular hypofunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
Last Updated

April 19, 2022

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

December 18, 2020

Last Update Submit

April 18, 2022

Conditions

Keywords

VertigoPeripheral Vestibular HypofunctionExercisesBalanceFunctional MobilityQuality of Life

Outcome Measures

Primary Outcomes (5)

  • Dizziness handicap inventory

    It used to assess the quality of life in patients with vertigo

    8 weeks

  • Tinetti balance test

    It used to asses the balance (questionnaire, score)

    8 weeks

  • Time up and go test

    It used to assses the functionality (sec)

    8 weeks

  • Adolescent/Adult Sensory Profile

    In the test, 6 different sensory processing processes are evaluated. Includes assessments of taste/smell process, movement process, visual processing, touch process, activity level and auditory processing. Each item is scored with likert measurements between 1 and 5 points determined by the person.

    8 weeks

  • Mobile application for Posture Analyze

    It used to assess Posture (Degree)

    8 weeks

Study Arms (3)

Grup I

EXPERIMENTAL

Proprioceptive vestibular rehabilitation exercises, Cawthorne Cooksey Exercises and Gaze Stabilization exercises,

Other: Proprioceptive vestibular exercise

Grup II

EXPERIMENTAL

Cawthorne Cooksey Exercises and Gaze Stabilization exercises

Other: Standard vestibular rehabilitation exercises

Grup III

OTHER

No intervention will be made, patients will be asked to continue their daily life

Other: Controlled

Interventions

To assess effects of proprioceptive vestibular exercises training in patients with peripheral vestibular hypofunctions

Also known as: Cawthorne cooksey exercises, Gaze stabilization exercises
Grup I

To assess effects of standard vestibular rehabilitation exercises in patients with peripheral vestibular hypofunctions

Also known as: Cawthorne Cooksey Exercises, Gaze Stabilization Exercises
Grup II

First and last measurement will be taken. There will be no intervention. study will include 9 patients.

Grup III

Eligibility Criteria

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

You may qualify if:

  • Between 18-65 years
  • Diagnosis of vertigo according to the clinical examination performed by an Otorhinolaryngologist, Vestibular Evoked Myogenic Potentials (VEMP), Video Head Impulse Test (VHIT)
  • Patients with Unilateral Peripheral Hypofunction
  • After giving detailed information about the research, agreeing to participate in the study.

You may not qualify if:

  • Severe hearing / vision impairment-loss
  • Patients with neurological, orthopedic, circulatory system problems that may cause vertigo, dizziness and balance disorders
  • Having severe hypertension / diabetes
  • Previous participation in a vestibular rehabilitation program
  • Being healthy
  • Patients using drugs that may affect the treatment negatively
  • Refusing to participate in a clinical trial
  • Patients who cannot adapt to the training program
  • Patients who discontinued their treatment
  • Patients with different diagnoses that may disrupt the treatment during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Battalgazi/MALATYA, 44280, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozaltin GE, Talu B, Bayindir T. The effect of proprioceptive vestibular rehabilitation on sensory-motor symptoms and quality of life. Arq Neuropsiquiatr. 2024 Nov;82(11):1-10. doi: 10.1055/s-0044-1790568. Epub 2024 Sep 24.

MeSH Terms

Conditions

VertigoVestibular DiseasesMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Burcu TALU, Assoc. Prof.

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental, Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 18, 2020

First Posted

December 29, 2020

Study Start

February 10, 2021

Primary Completion

June 18, 2021

Study Completion

June 25, 2021

Last Updated

April 19, 2022

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations