Combined Motor Imagery and Vestibular Rehab for MS

Официальное название

The Effectiveness of Combination of Motor Imagery and Vestibular Rehabilitation on Balance, Cognition, and Quality of Life in Patients With Multiple Sclerosis

Обзор

This trial investigates the first combined use of motor imagery and vestibular rehabilitation in multiple sclerosis, aiming to evaluate their joint effect on balance, cognition, and quality of life.

Подробное описание

Multiple sclerosis often causes balance disturbance, cognitive decline, and reduced quality of life. Motor imagery and vestibular rehabilitation are established methods in MS care, but their effects have only been studied separately. This randomized controlled trial introduces a combined program of motor imagery and vestibular training to explore whether their integration provides broader benefits. The study will recruit patients with relapsing-remitting MS, apply an 8-week intervention, and compare outcomes in cognition, balance, physical performance, and quality of life against conventional therapy.

Вмешательства

• Поведенческое Motor Imagery + Vestibular Rehabilitation group
  This 8-week program, 3 sessions/week, 55- 60 min each, includes 4 steps: Warm-up (5 min): Breathing exercises progressing from basic diaphragmatic and pursed-lip breathing (weeks 1-2), light movement with breathing (weeks 3-4), to Inspiratory Muscle Training device (weeks 5-8). Motor Imagery (15 min): Foundational phase (weeks 1-2) imagining basic movements, skills building (weeks 3-4) with functional daily tasks, advanced phase (weeks 5-8) imagining complex tasks, environmental and cognitive
• Поведенческое Conventional therapy group
  This 8-week program, 3 sessions/week, 55- 60 min each, includes: Warm-up: Seated/standing marching, neck and shoulder stretching. Strength \& Functional Movements: Sit-to-stand, side leg raises, step-ups. Core \& Upper Body: Bridge exercise, seated core activation, seated leg lifts, wall push-ups, seated shoulder press. Flexibility \& Balance: Calf and hamstring stretches, spinal flexibility, single-leg stance, lunges, tandem walking. Cool-down: Deep breathing and gentle stretching.

Первичные конечные точки

• Change in Cognitive Function (Montreal Cognitive Assessment [MoCA] Score) [Срок оценки: Baseline and 8 weeks after intervention]
• Change in Balance Berg Balance Scale \[ABBS] Score) [Срок оценки: Baseline (Week 0) and Post-intervention (Week 8)]
• Change in Vestibular Function (Dynamic Visual Acuity [DVA] Test) [Срок оценки: Baseline and Week 8.]
• Change in Vestibular Function (Head Impulse Test [HIT]) [Срок оценки: Baseline and Week 8]
• Change in Cognitive Function (Brief International Cognitive Assessment for MS \[BICAMS] Composite Score [Срок оценки: Baseline (Week 0) and Post-intervention (Week 8)]
• Change in balance (Timed Up and Go [TUG] Time) [Срок оценки: Baseline and Week 8]
• Change in Disability Status (Patient-Determined Disease Steps \[PDDS] Score) [Срок оценки: Baseline and Week 8.]

Вторичные конечные точки (1)

• Change in Quality of Life (Multiple Sclerosis Impact Scale-29 \[MSIS-29] [Срок оценки: Baseline and Week 8.]

Критерии участия

Критерии включения

• Diagnosis of Multiple Sclerosis (MS) Confirmed using McDonald Criteria
• Patient diagnosed relapsing-remitting multiple sclerosis (RRMS).
• Mild MS between 0-3 according to PDDS.
• Age from (18-45)
• Mild cognitive impairment
• Balance impairment (mild to moderate impairment)
• Vestibular dysfunction Related to MS (dizziness, vertigo , gaze instability ) 8. Native language is Arabic to ensure clear communication during cognitive tasks and exercise instructions

9\. Be able to joined the treatment (motor imagery, vestibular rehabilitaiton )

Критерии исключения

Other neurological disorder, progressive multiple sclerosis Non-MS related vestibular disorders (e.g., BPPV, Meniere's disease) that would interfere with vestibular rehab.

Severe Psychiatric Conditions (schizophrenia, bipolar, etc) Sever balance disorder Sever fatigue Medical instability eg (cardiovascular disease, respiratory, infections, severe uncontrolled diabetes, or severe visual impairments.) Sever cognitive impairment Pregnant Advance disability ( wheelchair , unable to stand ) Use of Vestibular-Suppressing Medications Non - speaker Arabic

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Gehad Salem Mohamed Mohamed Menshawi — Istanbul

Публикации

• Ozgen G, Karapolat H, Akkoc Y, Yuceyar N. Is customized vestibular rehabilitation effective in patients with multiple sclerosis? A randomized controlled trial. Eur J Phys Rehabil Med. 2016 Aug;52(4):466-78. Epub 2016 Apr 6. PMID 27050082
• Abraham A, Hart A, Andrade I, Hackney ME. Dynamic Neuro-Cognitive Imagery Improves Mental Imagery Ability, Disease Severity, and Motor and Cognitive Functions in People with Parkinson's Disease. Neural Plast. 2018 Mar 14;2018:6168507. doi: 10.1155/2018/6168507. eCollection 2018. PMID 29725348
• Aljarallah S, Alkhathlan H, Almushawah A, Badahdah A, Alfaifi N, Abdulmaged-Ahmed DA, Alkhawajah NM. Performance of an Arabic translation of the patient determined disease steps (PDDS) scale in Saudi patients with multiple sclerosis. Medicine (Baltimore). 2023 Nov 3;102(44):e35889. doi: 10.1097/MD.0000000000035889. PMID 37932990
• Rahman TT, El Gaafary MM. Montreal Cognitive Assessment Arabic version: reliability and validity prevalence of mild cognitive impairment among elderly attending geriatric clubs in Cairo. Geriatr Gerontol Int. 2009 Mar;9(1):54-61. doi: 10.1111/j.1447-0594.2008.00509.x. PMID 19260980
• Manago MM, Schenkman M, Berliner J, Hebert JR. Gaze stabilization and dynamic visual acuity in people with multiple sclerosis. J Vestib Res. 2016;26(5-6):469-477. doi: 10.3233/VES-160593. PMID 28262642
• Mulder T. Motor imagery and action observation: cognitive tools for rehabilitation. J Neural Transm (Vienna). 2007;114(10):1265-78. doi: 10.1007/s00702-007-0763-z. Epub 2007 Jun 20. PMID 17579805
• Urgesi C, Moro V, Candidi M, Aglioti SM. Mapping implied body actions in the human motor system. J Neurosci. 2006 Jul 26;26(30):7942-9. doi: 10.1523/JNEUROSCI.1289-06.2006. PMID 16870739
• Volz MS, Suarez-Contreras V, Portilla AL, Fregni F. Mental imagery-induced attention modulates pain perception and cortical excitability. BMC Neurosci. 2015 Mar 15;16:15. doi: 10.1186/s12868-015-0146-6. PMID 25887060

Идентификаторы

NCT: NCT07230015 · E-10840098-202.3.02-1593

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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