Effect of Vestibular Exercises on Post-Stroke Fatigue

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Control (Standard treatment)
  In control group participants will take one hour conventional physiotherapy including stretching, strengthening, balance and gait exercises in each session.
• Другое 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.

Первичные конечные точки

• Fatigue Impact Scale [Срок оценки: One week before rehabilitation program and one week after rehabilitation program.]
• The Fatigue Assessment Scale [Срок оценки: One week before rehabilitation program and one week after rehabilitation program.]

Вторичные конечные точки (2)

• Symbol Digit Modalities Test [Срок оценки: One week before rehabilitation program and one week after rehabilitation program.]
• Six Minutes Walking Test [Срок оценки: One week before rehabilitation program and one week after rehabilitation program.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 2 центра

• Hacettepe University — Ankara
• Hacettepe University — Ankara

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06956183 · KA-23056

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗