StrokeNCT06956183
Effect of Vestibular Exercises on Post-Stroke Fatigue
A study testing Vestibular exercise in people with Stroke, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Vestibular exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 26 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Hacettepe University
Ankara, 06100
Ayla Fil Balkan, Assoc Prof, +905354549027, aylafil@gmail.com
Ertan Kızılkaya, MSc
- Recruiting
Hacettepe University
Ankara
AYLA FİL BALKAN, Assoc.Prof. PhD, +905074708330, aylafil@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Control (Standard treatment), Vestibular exercise
- Keywords
- Stroke, Vestibular Exercise, Fatigue, Balance, Gait
- Medical subject headings
- Stroke, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (Standard treatment)Other
In control group participants will take one hour conventional physiotherapy including stretching, strengthening, balance and gait exercises in each session.
Vestibular exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Participants in the control group will participate in a one-hour conventional exercise program three times a week for eight weeks. Receives: Other: Control (Standard treatment) |
| Vestibular Group | Experimental | 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. Receives: Other: Vestibular exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Impact Scale
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.
Measured: One week before rehabilitation program and one week after rehabilitation program.
The Fatigue Assessment Scale
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.
Measured: One week before rehabilitation program and one week after rehabilitation program.
Secondary outcomes (2)
Symbol Digit Modalities Test
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.
Measured: One week before rehabilitation program and one week after rehabilitation program.
Six Minutes Walking Test
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.
Measured: One week before rehabilitation program and one week after rehabilitation program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start15 Jun 2025
- Primary completion26 Feb 2026 (estimated)
- Study completion26 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ayla fil balkan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956183
- Sponsor's protocol ID
- KA-23056
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oppenlander K, Utz KS, Reinhart S, Keller I, Kerkhoff G, Schaadt AK. Subliminal galvanic-vestibular stimulation recalibrates the distorted visual and tactile subjective vertical in right-sided stroke. Neuropsychologia. 2015 Jul;74:178-83. doi: 10.1016/j.neuropsychologia.2015.03.004. Epub 2015 Mar 3.
PubMed 25744870Ghaffari A, Asadi B, Zareian A, Akbarfahimi M, Raissi GR, Fathali Lavasani F. The Effects of Vestibular Rehabilitation on Poststroke Fatigue: A Randomized Controlled Trial Study. Stroke Res Treat. 2022 Aug 31;2022:3155437. doi: 10.1155/2022/3155437. eCollection 2022.
PubMed 36090743Mitsutake T, Sakamoto M, Ueta K, Oka S, Horikawa E. Effects of vestibular rehabilitation on gait performance in poststroke patients: a pilot randomized controlled trial. Int J Rehabil Res. 2017 Sep;40(3):240-245. doi: 10.1097/MRR.0000000000000234.
PubMed 28542112Angelaki DE, Klier EM, Snyder LH. A vestibular sensation: probabilistic approaches to spatial perception. Neuron. 2009 Nov 25;64(4):448-61. doi: 10.1016/j.neuron.2009.11.010.
PubMed 19945388Tramontano M, Bergamini E, Iosa M, Belluscio V, Vannozzi G, Morone G. Vestibular rehabilitation training in patients with subacute stroke: A preliminary randomized controlled trial. NeuroRehabilitation. 2018;43(2):247-254. doi: 10.3233/NRE-182427.
PubMed 30040765Su Y, Yuki M, Otsuki M. Non-Pharmacological Interventions for Post-Stroke Fatigue: Systematic Review and Network Meta-Analysis. J Clin Med. 2020 Feb 25;9(3):621. doi: 10.3390/jcm9030621.
PubMed 32106490Paciaroni M, Acciarresi M. Poststroke Fatigue. Stroke. 2019 Jul;50(7):1927-1933. doi: 10.1161/STROKEAHA.119.023552. Epub 2019 Jun 14. No abstract available.
PubMed 31195940Bernard-Espina J, Beraneck M, Maier MA, Tagliabue M. Multisensory Integration in Stroke Patients: A Theoretical Approach to Reinterpret Upper-Limb Proprioceptive Deficits and Visual Compensation. Front Neurosci. 2021 Apr 7;15:646698. doi: 10.3389/fnins.2021.646698. eCollection 2021.
PubMed 33897359Oliveira CB, Medeiros IR, Greters MG, Frota NA, Lucato LT, Scaff M, Conforto AB. Abnormal sensory integration affects balance control in hemiparetic patients within the first year after stroke. Clinics (Sao Paulo). 2011;66(12):2043-8. doi: 10.1590/s1807-59322011001200008.
PubMed 22189728Jang SH, Lee JH. Impact of sensory integration training on balance among stroke patients: sensory integration training on balance among stroke patients. Open Med (Wars). 2016 Aug 13;11(1):330-335. doi: 10.1515/med-2016-0061. eCollection 2016.
PubMed 28352817Sharony AF, Engel-Yeger B. Sensory Modulation and Participation in Daily Occupations in Stroke Survivors. Can J Occup Ther. 2021 Dec;88(4):375-383. doi: 10.1177/00084174211047372. Epub 2021 Oct 9.
PubMed 34632801Schambra HM, Sawaki L, Cohen LG. Modulation of excitability of human motor cortex (M1) by 1 Hz transcranial magnetic stimulation of the contralateral M1. Clin Neurophysiol. 2003 Jan;114(1):130-3. doi: 10.1016/s1388-2457(02)00342-5.
PubMed 12495773Plewnia C, Lotze M, Gerloff C. Disinhibition of the contralateral motor cortex by low-frequency rTMS. Neuroreport. 2003 Mar 24;14(4):609-12. doi: 10.1097/00001756-200303240-00017.
PubMed 12657896Kluger BM, Krupp LB, Enoka RM. Fatigue and fatigability in neurologic illnesses: proposal for a unified taxonomy. Neurology. 2013 Jan 22;80(4):409-16. doi: 10.1212/WNL.0b013e31827f07be.
PubMed 23339207Ponchel A, Bombois S, Bordet R, Henon H. Factors Associated with Poststroke Fatigue: A Systematic Review. Stroke Res Treat. 2015;2015:347920. doi: 10.1155/2015/347920. Epub 2015 May 25.
PubMed 26101691
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vestibular Exercise Program on Fatigue, Balance and Gait in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06956183
- Acronym / sponsor ID
- KA-23056
- Conditions
- Stroke
- Keywords
- Stroke, Vestibular Exercise, Fatigue, Balance, Gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 26 Feb 2026 (estimated)
- Study completion
- 26 Mar 2026 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Control (Standard treatment)Participants in the control group will participate in a one-hour conventional exercise program three times a week for eight weeks. |
| Vestibular Group | Experimental | Other: Vestibular exerciseIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control (Standard treatment)In control group participants will take one hour conventional physiotherapy including stretching, strengthening, balance and gait exercises in each session. | Other | Control group |
| Vestibular exerciseIn 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. | Other | Vestibular Group |
Primary outcome
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.
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.
2 secondary outcomes
Symbol Digit Modalities Test
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 25744870Oppenlander K, Utz KS, Reinhart S, Keller I, Kerkhoff G, Schaadt AK. Subliminal galvanic-vestibular stimulation recalibrates the distorted visual and tactile subjective vertical in right-sided stroke. Neuropsychologia. 2015 Jul;74:178-83. doi: 10.1016/j.neuropsychologia.2015.03.004. Epub 2015 Mar 3.
- Background: PubMed 36090743Ghaffari A, Asadi B, Zareian A, Akbarfahimi M, Raissi GR, Fathali Lavasani F. The Effects of Vestibular Rehabilitation on Poststroke Fatigue: A Randomized Controlled Trial Study. Stroke Res Treat. 2022 Aug 31;2022:3155437. doi: 10.1155/2022/3155437. eCollection 2022.
- Background: PubMed 28542112Mitsutake T, Sakamoto M, Ueta K, Oka S, Horikawa E. Effects of vestibular rehabilitation on gait performance in poststroke patients: a pilot randomized controlled trial. Int J Rehabil Res. 2017 Sep;40(3):240-245. doi: 10.1097/MRR.0000000000000234.
- Background: PubMed 19945388Angelaki DE, Klier EM, Snyder LH. A vestibular sensation: probabilistic approaches to spatial perception. Neuron. 2009 Nov 25;64(4):448-61. doi: 10.1016/j.neuron.2009.11.010.
- Background: PubMed 30040765Tramontano M, Bergamini E, Iosa M, Belluscio V, Vannozzi G, Morone G. Vestibular rehabilitation training in patients with subacute stroke: A preliminary randomized controlled trial. NeuroRehabilitation. 2018;43(2):247-254. doi: 10.3233/NRE-182427.
- Background: PubMed 32106490Su Y, Yuki M, Otsuki M. Non-Pharmacological Interventions for Post-Stroke Fatigue: Systematic Review and Network Meta-Analysis. J Clin Med. 2020 Feb 25;9(3):621. doi: 10.3390/jcm9030621.
- Background: PubMed 31195940Paciaroni M, Acciarresi M. Poststroke Fatigue. Stroke. 2019 Jul;50(7):1927-1933. doi: 10.1161/STROKEAHA.119.023552. Epub 2019 Jun 14. No abstract available.
- Background: PubMed 33897359Bernard-Espina J, Beraneck M, Maier MA, Tagliabue M. Multisensory Integration in Stroke Patients: A Theoretical Approach to Reinterpret Upper-Limb Proprioceptive Deficits and Visual Compensation. Front Neurosci. 2021 Apr 7;15:646698. doi: 10.3389/fnins.2021.646698. eCollection 2021.
- Background: PubMed 22189728Oliveira CB, Medeiros IR, Greters MG, Frota NA, Lucato LT, Scaff M, Conforto AB. Abnormal sensory integration affects balance control in hemiparetic patients within the first year after stroke. Clinics (Sao Paulo). 2011;66(12):2043-8. doi: 10.1590/s1807-59322011001200008.
- Background: PubMed 28352817Jang SH, Lee JH. Impact of sensory integration training on balance among stroke patients: sensory integration training on balance among stroke patients. Open Med (Wars). 2016 Aug 13;11(1):330-335. doi: 10.1515/med-2016-0061. eCollection 2016.
- Background: PubMed 34632801Sharony AF, Engel-Yeger B. Sensory Modulation and Participation in Daily Occupations in Stroke Survivors. Can J Occup Ther. 2021 Dec;88(4):375-383. doi: 10.1177/00084174211047372. Epub 2021 Oct 9.
- Background: PubMed 12495773Schambra HM, Sawaki L, Cohen LG. Modulation of excitability of human motor cortex (M1) by 1 Hz transcranial magnetic stimulation of the contralateral M1. Clin Neurophysiol. 2003 Jan;114(1):130-3. doi: 10.1016/s1388-2457(02)00342-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular exercise in people with Stroke, run by Hacettepe University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayla Fil Balkan, Assoc Prof (+903123051572, aylafil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Impact Scale (time frame: One week before rehabilitation program and one week after rehabilitation program.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06956183, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.