Effect of Vestibular Exercises on Post-Stroke Fatigue

NCT06956183 | Recruiting

• 1 other identifier: KA-23056
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Stroke

Keywords

Stroke; Vestibular Exercise; Fatigue; Balance; Gait

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  One week before rehabilitation program and one week after rehabilitation program.

Secondary Outcomes (2)

• Symbol Digit Modalities Test

  One week before rehabilitation program and one week after rehabilitation program.

• Six Minutes Walking Test

  One week before rehabilitation program and one week after rehabilitation program.

Other Outcomes (6)

• Fugl Meyer Assessment

  One week before rehabilitation program and one week after rehabilitation program.

• Fullerton Advanced Balance Scale

  One week before rehabilitation program and one week after rehabilitation program.

• Timed Up and Go Test

  One week before rehabilitation program and one week after rehabilitation program.

Study Arms (2)

Control group

OTHER

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)

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.

Other: Vestibular exercise

Interventions

Control (Standard treatment) OTHER

In control group participants will take one hour conventional physiotherapy including stretching, strengthening, balance and gait exercises in each session.

Control group

Vestibular exercise OTHER

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.

Vestibular Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (2)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

NOT YET RECRUITING

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (17)

• 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.

  PMID: 25744870 BACKGROUND

• Ghaffari 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.

  PMID: 36090743 BACKGROUND

• Mitsutake 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.

  PMID: 28542112 BACKGROUND

• Angelaki 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.

  PMID: 19945388 BACKGROUND

• Tramontano 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.

  PMID: 30040765 BACKGROUND

• Su 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.

  PMID: 32106490 BACKGROUND

• Paciaroni 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.

  PMID: 31195940 BACKGROUND

• Bernard-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.

  PMID: 33897359 BACKGROUND

• Oliveira 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.

  PMID: 22189728 BACKGROUND

• Jang 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.

  PMID: 28352817 BACKGROUND

• Sharony 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.

  PMID: 34632801 BACKGROUND

• Schambra 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.

  PMID: 12495773 BACKGROUND

• Plewnia 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.

  PMID: 12657896 BACKGROUND

• Kluger 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.

  PMID: 23339207 BACKGROUND

• Ponchel 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.

  PMID: 26101691 BACKGROUND

• McGeough E, Pollock A, Smith LN, Dennis M, Sharpe M, Lewis S, Mead GE. Interventions for post-stroke fatigue. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007030. doi: 10.1002/14651858.CD007030.pub2.

  PMID: 19588416 BACKGROUND

• Nadarajah M, Goh HT. Post-stroke fatigue: a review on prevalence, correlates, measurement, and management. Top Stroke Rehabil. 2015 Jun;22(3):208-20. doi: 10.1179/1074935714Z.0000000015. Epub 2015 Mar 17.

  PMID: 25779764 BACKGROUND

MeSH Terms

Conditions

Stroke; Fatigue

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ayla Fil Balkan, Assoc Prof

CONTACT

+903123051572; aylafil@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: Randomized Controlled

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: June 15, 2025
• Primary Completion: February 26, 2026
• Study Completion: March 26, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)