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临床试验/NCT07230015
NCT07230015尚未招募不适用

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

Medipol University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Change in Cognitive Function (Montreal Cognitive Assessment [MoCA] Score)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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."

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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 )
  • •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 )

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Motor Imagery + Vestibular Rehabilitation group (Behavioral)

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.

干预措施: Conventional therapy group (Behavioral)

结局指标

主要结局

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

时间窗: 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)

时间窗: 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, good balance. 2. 21-40: Moderate fall risk. 3. 0-20: High fall risk."

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

时间窗: 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])

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: Baseline and Week 8.

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

次要结局

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

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gehad Salem Mohamed Mohamed Menshawi

PT, MSc (Cand.)

Medipol University

研究点 (1)

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