NCT07230015

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Dec 2025Jul 2026

First Submitted

Initial submission to the registry

September 23, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Last Updated

April 30, 2026

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

September 23, 2025

Last Update Submit

April 26, 2026

Conditions

Keywords

physical therapyneurological rehabilitationMSVestibular rehabilitationMotor imagerybalanceQOLCognationrandomized control trialphysical therapy modalitiesPhysical therapy and rehabilitationphysical performanceMultiple Sclerosis

Outcome Measures

Primary Outcomes (7)

  • Change in Cognitive Function (Montreal Cognitive Assessment [MoCA] Score)

    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). 1. The test is scored out of 30 points. 2. A score of 26 or higher is considered normal. 3. Scores below 26 may indicate mild cognitive impairment or early dementia.

    Baseline and 8 weeks after intervention

  • Change in Balance Berg Balance Scale \[ABBS] Score)

    To assess balance and fall risk in Arabic-speaking patients with neurological disorders, lower scores indicate more severe balance problems (23). 1. 41-56: Low fall risk 2. 21-40: Moderate fall risk. 3. 0-20: High fall risk."

    Baseline (Week 0) and Post-intervention (Week 8)

  • Change in Vestibular Function (Dynamic Visual Acuity [DVA] Test)

    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])

    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

    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)

    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)

    Self-reported disability (0-8); higher scores indicate greater disability.

    Baseline and Week 8.

Secondary Outcomes (1)

  • Change in Quality of Life (Multiple Sclerosis Impact Scale-29 \[MSIS-29]

    Baseline and Week 8.

Study Arms (2)

Motor Imagery + Vestibular Rehabilitation Group

EXPERIMENTAL

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.

Behavioral: Motor Imagery + Vestibular Rehabilitation group

Conventional Group

OTHER

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.

Behavioral: Conventional therapy group

Interventions

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.

Conventional 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 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.

Motor Imagery + Vestibular Rehabilitation Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gehad Salem Mohamed Mohamed Menshawi

Istanbul, Beykoz/İstanbul, 34810, Turkey (TĂ¼rkiye)

RECRUITING

Related Publications (14)

  • 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: 27050082BACKGROUND
  • 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: 29725348BACKGROUND
  • 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: 37932990BACKGROUND
  • 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: 19260980BACKGROUND
  • 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: 28262642BACKGROUND
  • 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: 17579805BACKGROUND
  • 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: 16870739BACKGROUND
  • 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: 25887060BACKGROUND
  • 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.

    PMID: 27216225BACKGROUND
  • 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.

    PMID: 28360754BACKGROUND
  • 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.

    PMID: 33620411BACKGROUND
  • 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.

    PMID: 38097800BACKGROUND
  • 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.

    PMID: 33174475BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Merve Yılmaz Menek, Assoc. Prof

    Assoc. Prof. Merve Yılmaz Menek

    STUDY DIRECTOR

Central Study Contacts

Gehad Salem menshawi, PT, MSc (Cand.)

CONTACT

aliaa Salem menshawi, PT, MSc (Cand.)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will not be informed of their group allocation. Due to the nature of the intervention, the investigator and care provider will be aware of the assignments, and the outcome assessments will also be conducted by the investigator."
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a parallel group randomized controlled trial with two arms: an intervention group receiving motor imagery plus vestibular rehabilitation and a control group receiving conventional therapy only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc (Cand.)

Study Record Dates

First Submitted

September 23, 2025

First Posted

November 17, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

July 20, 2026

Last Updated

April 30, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations