Comparing the Acute Effects of Different Exercise Approaches in Patients With Multiple Sclerosis

NCT ID: NCT06721416

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-08-30

Brief Summary

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Multiple Sclerosis (MS) is the second most common neurological disorder in young adults after trauma. Treatments developed today can slow progression and reduce symptoms. Exercise therapy is a useful rehabilitation practice in MS to manage symptoms, restore function, optimize quality of life, ensure well-being and increase participation in daily life activities. In this study, it is planned to investigate the acute effects of conservative and virtual reality (VR)-based aerobic exercise applications and standard exercises that frequently form the rehabilitation programs of individuals with MS in clinics. For this purpose, patients with MS who met the inclusion criteria were given two-week intervals; Conservative aerobic exercise, virtual reality-based aerobic exercise and standard exercise practices will be performed. With the data obtained from this study, it is aimed to investigate the safety of aerobic exercises performed using VR tools that can be used in telerehabilitation applications, which are thought to have a very important place in MS rehabilitation in the future, in terms of acute body temperature increase, cognitive and physical fatigue caused by conservative methods and fNIRS cortical effects of VR-based aerobic exercise applications. It will be possible to prove it with objective methods such as.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Virtual Reality Beased

VR based aerobic exercise

Group Type EXPERIMENTAL

VR Based Aerobic Exercise

Intervention Type OTHER

In the virtual reality-based aerobic exercise training, the game called "Beat Saber" will be played with Oculus Quest 2 virtual reality for 30 minutes.

Traditional

Cycling ergometer based aerobic exercise

Group Type EXPERIMENTAL

Traditional Aerobic Exercise

Intervention Type OTHER

Traditional aerobic exercise will be continued with an arm ergometer, at moderate intensity, for 30 minutes.

Conventional

Conventional physical therapy approaches

Group Type EXPERIMENTAL

Conventional Exercise

Intervention Type OTHER

The conventional exercise program will be modified with stabilization, balance and strengthening exercises, taking into account the functional status of the participants.

Interventions

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Traditional Aerobic Exercise

Traditional aerobic exercise will be continued with an arm ergometer, at moderate intensity, for 30 minutes.

Intervention Type OTHER

VR Based Aerobic Exercise

In the virtual reality-based aerobic exercise training, the game called "Beat Saber" will be played with Oculus Quest 2 virtual reality for 30 minutes.

Intervention Type OTHER

Conventional Exercise

The conventional exercise program will be modified with stabilization, balance and strengthening exercises, taking into account the functional status of the participants.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed as Relapsing Remitting MS by neurologist according to the McDonald Criteria.
* 18-55 years old.
* EDSS score \< 4.5
* Mini mental examination test score ≥ 24
* No MS attack in the last 6 months.
* No visual or vestibular deficits.
* Signed the written consent form.

Exclusion Criteria

* Having previous full immersive VR experience.
* Having an additional neurological disease.
* Spasticity in any muscle of the upper extremity \> 3, according to MAS.
* Continuing the active physical therapy and rehabilitation program.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Merve Sevik Dönderici

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merve Sevik Dönderici, MSc

Role: PRINCIPAL_INVESTIGATOR

Acibadem University

Locations

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Acibadem University

Ataşehir, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023-07/229

Identifier Type: -

Identifier Source: org_study_id

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