- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07230015
Combined Motor Imagery and Vestibular Rehab for MS (MIVR-MS)
The Effectiveness of Combination of Motor Imagery and Vestibular Rehabilitation on Balance, Cognition, and Quality of Life in Patients With Multiple Sclerosis
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gehad Salem menshawi, PT, MSc (Cand.)
- Phone Number: +905524590178 +201040131964
- Email: j.menshawi@hotmail.com
Study Contact Backup
- Name: aliaa Salem menshawi, PT, MSc (Cand.)
- Phone Number: +9055244212805
- Email: aliaamenshawi@gmail.com
Study Locations
-
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Beykoz/İstanbul
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Istanbul, Beykoz/İstanbul, Turkey (Türkiye), 34810
- Recruiting
- Gehad Salem Mohamed Mohamed Menshawi
-
Contact:
- gehad Salem Menshawi, PT, MSc (Cand.)
- Phone Number: +905524590178 01040131964
- Email: j.menshawi@hotmail.com
-
Contact:
- Email: j.menshawi@hotmail.com
-
Principal Investigator:
- gehad menshawi, MSc (Cand.)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
inclusion criteria
- 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 )
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motor Imagery + Vestibular Rehabilitation Group
Participants receive a combined intervention of motor imagery and vestibular rehabilitation.
Sessions last 55 minutes, including 5 min breathing warm-up, 20 min motor imagery training, 20 min vestibular exercises for balance and dizziness reduction, and 10 min cool-down/relaxation.
The program aims to improve balance, cognitive function, and quality of life in patients with Multiple Sclerosis.
Symptoms are monitored to avoid overexertion or symptom exacerbation.
|
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 challenges (e.g., sports, obstacle navigation, walking on uneven surfaces). Vestibular Rehabilitation (15 min): Foundational (weeks 1-2) gaze stabilization and static balance (VOR, VSR, VCR), dynamic balance and dual-task exercises (weeks 3-6), advanced functional balance and vestibular-cognition integration (weeks 7-8). Cool-down (10 min): Relaxation and symptom monitoring to prevent overexertion, dizziness, or fatigue. |
|
Other: Conventional Group
Participants receive conventional care for Multiple Sclerosis, including routine medical follow-up and standard physiotherapy if applicable.
No specific motor imagery or vestibular rehabilitation exercises are administered.
This group serves as a comparison to evaluate the effects of the experimental intervention.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cognitive Function (Montreal Cognitive Assessment [MoCA] Score)
Time Frame: Baseline and 8 weeks after intervention
|
It is a cognitive screening tool commonly used in clinics and research to assess individual cognitive impairment and its severity. It helps therapists evaluate a patient's cognitive function and identify changes over time by assessing mental capacity functions and takes about 10-15 minutes to complete., which includes Attention & Concentration, Executive Functions, Memory, Language, Visuospatial Skills and Orientation (19).
|
Baseline and 8 weeks after intervention
|
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Change in Vestibular Function (Dynamic Visual Acuity [DVA] Test)
Time Frame: Baseline and Week 8.
|
DVA assesses visual acuity during head movement to evaluate vestibulo-ocular reflex integrity.It is a functional test designed to evaluate the integrity of the vestibulo-ocular reflex (VOR), which stabilizes the eyes during head motion.
DVA is commonly employed to detect vestibular dysfunction and is particularly useful for evaluating vestibular function in patients experiencing dizziness, balance disorders, or conditions such as multiple sclerosis (MS), where vestibular dysfunction is common
|
Baseline and Week 8.
|
|
Change in Vestibular Function (Head Impulse Test [HIT])
Time Frame: Baseline and Week 8
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Bedside assessment of semicircular canal/VOR function.
Outcome recorded as presence/absence of corrective saccades and qualitative clinician rating of gain; improvement indicates better vestibular function.It is a clinical test used to identify deficits in the semicircular canals, especially the horizontal canal, and is useful for detecting peripheral vestibular deficits.
It assesses the ability of the vestibulo-ocular reflex (VOR) to maintain stable vision during rapid, unpredictable head movements
|
Baseline and Week 8
|
|
Change in Cognitive Function (Brief International Cognitive Assessment for MS \[BICAMS] Composite Score
Time Frame: Baseline (Week 0) and Post-intervention (Week 8)
|
Cognition will be assessed using BICAMS (SDMT, CVLT-II, BVMT-R).
A composite and subtest scores will be calculated; This test is valdiated in Egyption dialect.
It is a specialized tool designed for patients with multiple sclerosis to assess their cognitive function.
It is reliable, quick, and sensitive, making it useful for both clinical settings and research.
The tool focuses on cognitive domains that are commonly affected in multiple sclerosis, such as memory, speed, and learning.
It includes tests like the Symbol Digit Modalities Test (SDMT), California Verbal Learning Test-II (CVLT-II), and Brief Visuospatial Memory Test-Revised (BVMT-R)
|
Baseline (Week 0) and Post-intervention (Week 8)
|
|
Change in balance (Timed Up and Go [TUG] Time)
Time Frame: Baseline and Week 8
|
Seconds to stand up, walk 3 m, turn, return, and sit.
Lower times indicate better mobility; ≥12 s suggests increased fall risk.
|
Baseline and Week 8
|
|
Change in Disability Status (Patient-Determined Disease Steps \[PDDS] Score)
Time Frame: Baseline and Week 8.
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Self-reported disability (0-8); higher scores indicate greater disability.
|
Baseline and Week 8.
|
|
Change in Balance Berg Balance Scale \[ABBS] Score)
Time Frame: Baseline (Week 0) and Post-intervention (Week 8)
|
To assess balance and fall risk in Arabic-speaking patients with neurological disorders, lower scores indicate more severe balance problems (23).
|
Baseline (Week 0) and Post-intervention (Week 8)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of Life (Multiple Sclerosis Impact Scale-29 \[MSIS-29]
Time Frame: Baseline and Week 8.
|
The Multiple Sclerosis Impact Scale-29 (MSIS-29) is a clinical tool used by patients to assess the impact of MS on their quality of life.
The questionnaire consists of 29 questions and evaluates both physical and psychological well-being, helping to determine how MS affects daily life
|
Baseline and Week 8.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Merve Yılmaz Menek, Assoc. Prof, Assoc. prof. Merve Yılmaz Menek
Publications and helpful links
General Publications
- Khan F, Amatya B. Rehabilitation in Multiple Sclerosis: A Systematic Review of Systematic Reviews. Arch Phys Med Rehabil. 2017 Feb;98(2):353-367. doi: 10.1016/j.apmr.2016.04.016. Epub 2016 May 20.
- 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.
- 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.
- Walton C, King R, Rechtman L, Kaye W, Leray E, Marrie RA, Robertson N, La Rocca N, Uitdehaag B, van der Mei I, Wallin M, Helme A, Angood Napier C, Rijke N, Baneke P. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler. 2020 Dec;26(14):1816-1821. doi: 10.1177/1352458520970841. Epub 2020 Nov 11.
- McGinley MP, Goldschmidt CH, Rae-Grant AD. Diagnosis and Treatment of Multiple Sclerosis: A Review. JAMA. 2021 Feb 23;325(8):765-779. doi: 10.1001/jama.2020.26858.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Efendi H. Clinically Isolated Syndromes: Clinical Characteristics, Differential Diagnosis, and Management. Noro Psikiyatr Ars. 2015 Dec;52(Suppl 1):S1-S11. doi: 10.5152/npa.2015.12608. Epub 2015 Dec 1.
- Habbestad A, Willumsen JS, Aarseth JH, Grytten N, Midgard R, Wergeland S, Myhr KM, Torkildsen O. Increasing age of multiple sclerosis onset from 1920 to 2022: a population-based study. J Neurol. 2024 Apr;271(4):1610-1617. doi: 10.1007/s00415-023-12047-9. Epub 2023 Dec 14.
- Garcia-Munoz C, Cortes-Vega MD, Heredia-Rizo AM, Martin-Valero R, Garcia-Bernal MI, Casuso-Holgado MJ. Effectiveness of Vestibular Training for Balance and Dizziness Rehabilitation in People with Multiple Sclerosis: A Systematic Review and Meta-Analysis. J Clin Med. 2020 Feb 21;9(2):590. doi: 10.3390/jcm9020590.
Helpful Links
- Clinical characteristics of patients with multiple sclerosis enrolled in a new registry in Egypt
- Multiple Sclerosis: Pathogenesis, Symptoms, Diagnoses and Cell-Based Therapy
- Review of multiple sclerosis: Epidemiology, etiology, pathophysiology, and treatment
- Book Multiple Sclerosis Rehabilitation From Impairment to Participation Edited ByMarcia Finlayson
- Effectiveness of Motor Imagery on Motor Recovery in Patients with Multiple Sclerosis: Systematic Review
- The Effectiveness of Vestibular Rehabilitation on Balance Related Impairments among Multiple Sclerosis Patients: A Systematic Review
- Motor imagery in multiple sclerosis: exploring applications in therapeutic treatment
- Effectiveness of Vestibular Training for Balance and Dizziness Rehabilitation in People with Multiple Sclerosis: A Systematic Review and Meta-Analysis
- Vestibular Rehabilitation
- Reliability and validity of Arabic version of the brief international cognitive assessment for multiple sclerosis: Egyptian dialect
- Advances in dynamic visual acuity test research
- Validation of the Arabic version of the Berg Balance Scale (A-BBS) among elderly residents in a rural community
- The reliability and validity of the Timed Up and Go as a clinical tool in individuals with and without disabilities across a lifespan: a systematic review
- Validation of the Arabic Version of the Multiple Sclerosis Impact Scale (MSIS-29): a Rasch Analysis Study
- Combined upper limb and breathing exercise programme for pain management in ambulatory and non-ambulatory multiple sclerosis individuals: part II analyses from feasibility study
- Exercise and multiple sclerosis
- Best practice for motor imagery: a systematic literature review on motor imagery training elements in five different disciplines
- Effects of Motor Imagery Training on Balance and Gait in Older Adults: A Randomized Controlled Pilot Study
- Rehabilitation to improve gaze and postural stability in people with multiple sclerosis: study protocol for a prospective randomized clinical trial
- Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort stu
- Exercises for multiple sclerosis : a safe and effective program to fight fatigue, build strength, and improve balance
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-1593
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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