NCT04425928

Brief Summary

In this study it was aimed to investigate the effects of home treatment program based standard activity on dizziness, balance and daily life activity in patients with dizziness complaint originated from chronic unilateral peripheral vestibular disorder and compare to effects of exercise-based home rehabilitation program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

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

April 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

1.1 years

First QC Date

June 1, 2020

Last Update Submit

August 7, 2020

Conditions

Vestibular Disorder

Outcome Measures

Primary Outcomes (1)

  • Change from before and after treatment in the severity of dizziness on Visual Analog scale (VAS).

    VAS is a self-reported instrument assessing the severity of diziness.

    before and after treatment (4 weeks)

Secondary Outcomes (1)

  • Change from before and after treatment in the Independent level of activity in the daily life on Vestibular Disorders Activities of Daily Living Scale (VADL).

    before and after treatment (4 weeks)

Other Outcomes (1)

  • Change from before and after treatment in the postural stability on Computerized Dynamic Posturography (CDP).

    before and after treatment (4 weeks)

Study Arms (3)

activity group

ACTIVE COMPARATOR

Participants received an activity-based home program that was performed for 4 weeks.

Procedure: occupational therapy based activity training programs

exercise group

EXPERIMENTAL

Participants received an exercise-based home program was performed that was performed for 4 weeks.

Procedure: Physiotherapy based exercise training programs

control group

NO INTERVENTION

No intervention

Interventions

occupational therapy based activity training programsPROCEDURE

Occupational therapy based activity training programs in which exercises based on physiotherapy are put into the purposeful activities at vestibular rehabilitation.

Also known as: purposeful activities
activity group
Physiotherapy based exercise training programsPROCEDURE

Cawthorne-cooksey exercises were performed at vestibular rehabilitation

Also known as: Cawthorne-cooksey exercises
exercise group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients have dizziness complaint longer than 3 months,
  • History of at least one dizziness in a month
  • Patient has been diagnosed chronic unilateral peripheric vestibular disorder

You may not qualify if:

  • Patients with diagnosed benign paroxysmal positional vertigo, had Meniere's disease, had history of central nerve system impairments and/or psychiatric disorder, had uncontrolled hypertension and diabetes, had not understanding simple verbal instruction and following ability, not able to stand independent in the standstill position, had visual problems that cannot be treated with lenses or glasses, had movement limitation due to the orthopedic problem, using medication for dizziness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (1)

  • Tekin Dal B, Bumin G, Aksoy S, Gunaydin RO. Comparison of Activity-Based Home Program and Cawthorne-Cooksey Exercises in Patients With Chronic Unilateral Peripheral Vestibular Disorders. Arch Phys Med Rehabil. 2021 Jul;102(7):1300-1307. doi: 10.1016/j.apmr.2020.12.022. Epub 2021 Jan 30.

    PMID: 33529612DERIVED

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Gonca Bumin, Prof

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 11, 2020

Study Start

April 15, 2018

Primary Completion

June 1, 2019

Study Completion

November 19, 2019

Last Updated

August 11, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)