Effect of Vestibular Exercises on Post-Stroke Fatigue

December 2, 2025 updated by: ayla fil balkan, Hacettepe University

The Effect of Vestibular Exercise Program on Fatigue, Balance and Gait in Patients With Stroke

The goal of this clinical trial is to search effects of vestibuler exercises on post-stroke fatigue. The main question it aims to answer is:

wer are:

- Do vestibuler excercises decrease post-stroke perceived and physiologic fatigue?

Researchers will compare the effects of vestibuler exercises to conventional rehabilitation to find out the superior one.

Participants will:

  • take a one-hour conventional rehabilitation or vestibuler exercise program three times in a week.
  • be assessed in terms of fatigue before and after rehabilitation programs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

One of the most common complications after stroke is fatigue. Fatigue prolongs the rehabilitation period and delays recovery. Although medical treatments, exercise programs and activity modifications are recommended to reduce fatigue after stroke, an effective evidence-based treatment method has not yet been developed. Vestibular exercises can improve oculomotor and postural control by trying to provide sensory integration through adaptation and compensatory mechanisms, thus increasing cortical excitability and reducing fatigue.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ayla Fil Balkan, Assoc Prof
  • Phone Number: +903123051572
  • Email: aylafil@gmail.com

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Hacettepe University
        • Contact:
          • AYLA FİL BALKAN, Assoc.Prof. PhD
          • Phone Number: +905074708330
          • Email: aylafil@gmail.com
      • Ankara, Turkey (Türkiye), 06100
        • Not yet recruiting
        • Hacettepe University
        • Contact:
        • Principal Investigator:
          • Ertan Kızılkaya, MSc
        • Sub-Investigator:
          • Mehmet Akif Topçuoğlu, Prof Dr
        • Sub-Investigator:
          • Ethem Murat Arsava, Prof Dr
        • Sub-Investigator:
          • Semra Topuz, Prof Dr
        • Sub-Investigator:
          • Yeliz Salcı, Assoc Prof
        • Sub-Investigator:
          • Ali İmran Yalçın, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Volunteering to participate in the study Being between the ages of 18-65 Having had an anterior circulation stroke at least 6 months ago Being at least stage 3 according to the Functional Ambulation Classification Scoring at least 22 on the Montreal Cognitive Assessment Scale

Exclusion Criteria:

  • Having another orthopedic, neurological or other systemic disease that prevents working Having severe aphasia Having a disease other than stroke that causes primary fatigue Using medication that will affect cognitive status Using medication that will affect fatigue

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Participants in the control group will participate in a one-hour conventional exercise program three times a week for eight weeks.
Other: Control (Standard treatment)
In control group participants will take one hour conventional physiotherapy including stretching, strengthening, balance and gait exercises in each session.
Experimental: Vestibular Group
In vestibular group (study group) participants in the study group will receive 20 minutes of vestibular training in addition to a 40-minute conventional exercise program, three times a week for eight weeks.
Other: Vestibular exercise
In vestibular group (study group) participant will take 40 minutes conventional physiotherapy including stretching, strengthening, balance and gait exercises, and 20 minutes vestibular exercises including head and gaze stabilization, occulomotor, head turning and balance exercises in different postures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Impact Scale
Time Frame: One week before rehabilitation program and one week after rehabilitation program.
The Fatigue Impact Scale (FIS) will be used. The FIS, which provides information on the presence and severity of fatigue, asks patients to evaluate 10 physical, 10 cognitive, and 20 psychosocial function-related statements within the scope of their fatigue levels in the last month. Each statement can take a value between 0 and 4. 0 indicates no problem, while 4 indicates the most severe problem. The total scale score varies between 0 and 160. A higher score indicates that the effect of fatigue is greater.
One week before rehabilitation program and one week after rehabilitation program.
The Fatigue Assessment Scale
Time Frame: One week before rehabilitation program and one week after rehabilitation program.
The Fatigue Assessment Scale (FAS) consists of 10 items. Responses are given on a five-point Likert scale, with 1 for "never" and 5 for "always". The FAS asks participants to rate how they feel on a daily basis.
One week before rehabilitation program and one week after rehabilitation program.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symbol Digit Modalities Test
Time Frame: One week before rehabilitation program and one week after rehabilitation program.
Physiological mental fatigue will be assessed with the Symbol Digit Modalities Test (SDMT). In the test, 9 numbers are represented by 9 symbols. In the test, participants will be asked to match the symbols given in a mixed manner with the numbers for a period of 180 seconds by looking at the guide. The number of correct answers will be recorded 6 times, every 30 seconds. The difference between the cognitive fatigue value 1. Score and 6. Score will be recorded as the fatigue value.
One week before rehabilitation program and one week after rehabilitation program.
Six Minutes Walking Test
Time Frame: One week before rehabilitation program and one week after rehabilitation program.
The assessment of physiological fatigue will be made by calculating the time-dependent change in walking distance with the ambulatory walking index as a result of the 6-minute walking test (6MWT). At the beginning of the test, participants will be instructed to complete "as much distance as possible, aiming to complete at the highest speed". The distances walked per minute and the total distance will be recorded and expressed in meters. In order to measure the decrease in the distance walked from the first minute to all other minutes of the 6-minute walking test, the percentage change in the distance walked will be calculated starting from the second minute. Objective measurement of fatigue will be made by decreasing walking distance between 1 and 6 minutes.
One week before rehabilitation program and one week after rehabilitation program.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl Meyer Assessment
Time Frame: One week before rehabilitation program and one week after rehabilitation program.
Motor functionality will be assessed with the Fugl Meyer Upper Extremity (FMA-UE) and Fugl Meyer Lower Extremity (FMA-LE) scales. FMA-UE is a frequently used assessment tool to assess motor recovery of the upper extremity after stroke. Scoring is as follows; 0= cannot perform, 1= partially perform, 2= fully perform. The total score for upper extremity motor function is 66. FMA-LE is a disease-specific impairment assessment designed to assess motor function, balance, sensory qualities, and joint function in patients after stroke. Scoring is as follows; 0= cannot perform, 1= partially perform, 2= fully perform.
One week before rehabilitation program and one week after rehabilitation program.
Fullerton Advanced Balance Scale
Time Frame: One week before rehabilitation program and one week after rehabilitation program.
Fullerton Advanced Balance Scale is a scale developed to evaluate small changes in balance in multiple ways. The highest score that can be obtained from the scale consisting of 10 items scored between 0 and 4 is 40. FAB is a scale that can be applied quickly (∼10-12 min) and does not require space. Its validity and reliability have been shown in stroke patients, and the cut-off score has been determined as 21.5.
One week before rehabilitation program and one week after rehabilitation program.
Timed Up and Go Test
Time Frame: One week before rehabilitation program and one week after rehabilitation program.
Timed Up and Go Test; verbal instructions are given to the patient, and the patient is asked to get up from the chair, walk 3 meters as quickly and safely as possible following a line marked on the floor, turn, walk back and sit down. 10 seconds and below; the patient walks independently, the risk of falling is very low. 11-19 seconds; the patient walks independently, the risk of falling is low to moderate. 20-29 seconds; the patient may need help from time to time, the risk of falling is moderate to high. Over 30 seconds, the risk of falling is high and the need for help from time to time
One week before rehabilitation program and one week after rehabilitation program.
Bertec Force Plate (Balance Check Screener™ BP5050 20x20´´ Bertec Comporation Columbus, OH, USA)
Time Frame: One week before rehabilitation program and one week after rehabilitation program.
Bertec force plate (Balance Check Screener™ BP5050 20x20´´ Bertec Comporation Columbus, OH, USA) is a three-component balance platform that is based on objectively measuring instantaneous changes in vertical force and pressure center. It consists of a total of 5 tests, including tests for 4 different situations in static stance and a test that includes stability limits. The participant is asked to wait 10 seconds without moving in each situation with eyes open and eyes closed on hard and soft ground. Oscillations are recorded by the device for evaluation during the test.
One week before rehabilitation program and one week after rehabilitation program.
The GAITRite Gait Analysis System (CIR Systems Inc., Franklin, New Jersey, USA)
Time Frame: One week before rehabilitation program and one week after rehabilitation program.
The GAITRite Gait Analysis System (CIR Systems Inc., Franklin, New Jersey, USA) will be used to evaluate the participants' gait cycle time, gait speed (cm/s), cadence (step/min), step length (cm), double step length (cm), step width (cm), foot angle (°), support surface (cm), single leg stance time (%GC), and time-distance characteristics of individuals' gait, such as plantar pressure distributions, while they walk at their own pace. The GAITRite system is considered the gold standard in the evaluation of time-distance characteristics of gait (29). The participants' walks will be repeated 3 times and the average of the data related to the gait will be used in the analyses
One week before rehabilitation program and one week after rehabilitation program.
Functional Gait Assessment
Time Frame: One week before rehabilitation program and one week after rehabilitation program.
Walking performance and functionality will be assessed with the Functional Gait Assessment (FGA). The FGA is an ambulation-based balance test initially proposed to assess higher-level balance in individuals with vestibular disorders. Although it was developed for use in patients with vestibular pathologies, it has since been used as an outcome measure in a variety of patient populations. The FGA was developed as a modification of the dynamic gait index to increase reliability and reduce the ceiling effect commonly seen with the DGI, with three items added to the 7 items of the dynamic gait index: "walking with narrow-based support," "walking backward," and "walking with eyes closed." Each of the 10 items in the FGA is scored from 0 to 3, with a best score of 30. Validity and reliability have been demonstrated in stroke patients
One week before rehabilitation program and one week after rehabilitation program.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2025

Primary Completion (Estimated)

February 26, 2026

Study Completion (Estimated)

March 26, 2026

Study Registration Dates

First Submitted

April 25, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA-23056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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