Multiple Sclerosis (MS) - Relapsing-remitting
Conditions
Keywords
physical therapy, neurological rehabilitation, MS, Vestibular rehabilitation, Motor imagery, balance, QOL, Cognation, randomized control trial, physical therapy modalities, Physical therapy and rehabilitation, physical performance, Multiple Sclerosis
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.
Detailed description
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.
Interventions
BEHAVIORALMotor 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 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.
BEHAVIORALConventional 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.
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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."
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of Multiple Sclerosis (MS) Confirmed using McDonald Criteria 2. Patient diagnosed relapsing-remitting multiple sclerosis (RRMS). 3. Mild MS between 0-3 according to PDDS. 4. Age from (18-45) 5. Mild cognitive impairment 6. Balance impairment (mild to moderate impairment) 7. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function (Montreal Cognitive Assessment [MoCA] Score) | 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). 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. |
| Change in Balance Berg Balance Scale \[ABBS] Score) | 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). 1. 41-56: Low fall risk 2. 21-40: Moderate fall risk. 3. 0-20: High fall risk." |
| Change in Vestibular Function (Dynamic Visual Acuity [DVA] Test) | 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 |
| Change in Vestibular Function (Head Impulse Test [HIT]) | Baseline and Week 8 | 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 |
| Change in Cognitive Function (Brief International Cognitive Assessment for MS \[BICAMS] Composite Score | 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) |
| Change in balance (Timed Up and Go [TUG] Time) | 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. |
| Change in Disability Status (Patient-Determined Disease Steps \[PDDS] Score) | Baseline and Week 8. | Self-reported disability (0-8); higher scores indicate greater disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (Multiple Sclerosis Impact Scale-29 \[MSIS-29] | 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 |
Countries
Turkey (Türkiye)
Contacts
CONTACTGehad Salem menshawi, PT, MSc (Cand.)
CONTACTaliaa Salem menshawi, PT, MSc (Cand.)
STUDY_DIRECTORMerve Yılmaz Menek, Assoc. Prof
Assoc. Prof. Merve Yılmaz Menek
Outcome results
None listed