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Activity Treatment on Vestibular Rehabilitation

Primary Purpose

Vestibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
occupational therapy based activity training programs
Physiotherapy based exercise training programs
Sponsored by
Bilgehan Tekin Dal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

activity group

exercise group

control group

Arm Description

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

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

No intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
VADL is a questionnaire assessing the Independent level of activity in daily life.

Full Information

First Posted
June 1, 2020
Last Updated
August 7, 2020
Sponsor
Bilgehan Tekin Dal
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1. Study Identification

Unique Protocol Identification Number
NCT04425928
Brief Title
Activity Treatment on Vestibular Rehabilitation
Official Title
Comparison of Activity-Based Home Program and Cawthorne-Cooksey Exercises in Patients With Chronic Unilateral Peripheral Vestibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
November 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bilgehan Tekin Dal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The aim of this study was to assess the effects of an activity training programme on dizziness, imbalance, and level of independence in daily living activities in patients with chronic dizziness. 75 patients between 18-65 years of age who diagnosed chronic peripheral vestibular disorders and individuals with vestibular rehabilitation indications were included in our study. Patients were randomly divided into 3 groups consist of 25 patients as an activity group, exercise group, and control group. Education was given to each group. İn addition, the activity group was performed a training activities program, the exercise group was performed in the Cawthorne-Cooksey exercises program. Therapy programs were prescribed once daily at home for 4 weeks. After demographic information was obtained from all patients, assessments were performed at the beginning and at the end of the treatment program (4 weeks). Dizziness severity was assessed by the Visual Analog Scale (VAS), activities of daily livings were assessed by Vestibular Disorders Activity Questionnaire (VADL) and balance was assessed by Sensory Organization Testing (SOT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
activity group
Arm Type
Active Comparator
Arm Description
Participants received an activity-based home program that was performed for 4 weeks.
Arm Title
exercise group
Arm Type
Experimental
Arm Description
Participants received an exercise-based home program was performed that was performed for 4 weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Procedure
Intervention Name(s)
occupational therapy based activity training programs
Other Intervention Name(s)
purposeful activities
Intervention Description
Occupational therapy based activity training programs in which exercises based on physiotherapy are put into the purposeful activities at vestibular rehabilitation.
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy based exercise training programs
Other Intervention Name(s)
Cawthorne-cooksey exercises
Intervention Description
Cawthorne-cooksey exercises were performed at vestibular rehabilitation
Primary Outcome Measure Information:
Title
Change from before and after treatment in the severity of dizziness on Visual Analog scale (VAS).
Description
VAS is a self-reported instrument assessing the severity of diziness.
Time Frame
before and after treatment (4 weeks)
Secondary Outcome Measure Information:
Title
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).
Description
VADL is a questionnaire assessing the Independent level of activity in daily life.
Time Frame
before and after treatment (4 weeks)
Other Pre-specified Outcome Measures:
Title
Change from before and after treatment in the postural stability on Computerized Dynamic Posturography (CDP).
Description
Computerized dynamic posturography (CDP) testing is a technique used to assess underlying sensory and motor control impairments associated with balance disorders.
Time Frame
before and after treatment (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonca Bumin, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33529612
Citation
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.
Results Reference
derived

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Activity Treatment on Vestibular Rehabilitation

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