The Effect of Task-Oriented Training and Virtual Reality Training on Balance, Gait and Fatigue in Individuals With Multiple Sclerosis

NCT07000968 | Completed

• 1 other identifier: 1421
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Multiple sclerosis (MS) is a chronic disease of the central nervous system. Task-focused training is an approach that relies on multiple repetitions of motor performance. Virtual reality is a technology that combines computer graphics to create a realistic world that responds to the user's responses. Purpose: The study was planned to observe the effect of virtual reality training on balance, walking and fatigue and to compare it with task-oriented training. Materials and Methods: The study, designed as a randomized controlled study, will include individuals with multiple sclerosis between the ages of 20-65. The population of the study consists of individuals with MS at Elazig Private Ada Special Education and Rehabilitation Center. Individuals who agree to participate in the study and meet the inclusion criteria will be selected by trying to reach the entire relevant population and will be divided into three groups using the sealed envelope method. Individuals will be evaluated before treatment and at the 8th week after treatment. One of the experimental groups will receive task-oriented training in the clinic 3 days a week, 40 minutes a day for 8 weeks, virtual reality training will be applied to the other, and conventional training will be applied to the control group. Expanded disability status scale to evaluate physical disability; balance assessment berg balance scale; gait assessment rivermead visual gait assessment scale; Fatigue assessment will be evaluated using the fatigue severity scale. Result: The effects of task-oriented and virtual reality training groups on balance, walking and fatigue will be interpreted by comparing the evaluation results before and after the treatment program. Unique Value: The study will contribute to the literature as it is the first study comparing the superiority of virtual reality training over task-oriented education in individuals with multiple sclerosis and the superiority of virtual reality training and task-oriented education over conventional education. In addition, it will contribute to the literature as it is the first study to observe the effects of task-oriented training and virtual reality training on balance, walking and fatigue in individuals with multiple sclerosis.

Conditions

Multiple Sclerosis; Balance Impairment, Gait Disorders, Fatigue; Multiple Sclerosis Bening; Multiple Sclerosis Relapsing Remitting

Keywords

Task Oriented Training; Virtual Reality; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Berg Balance Test

  It takes between 15 and 20 minutes to make. The patient who will be evaluated with the Berg balance scale must understand the commands given. 14 basic functions are questioned throughout the evaluation. For example; standing up from a sitting position. Each function is scored with a score between "0" and "4". While a score of 4 indicates that the patient is independent in that function, a score of 0 means that the patient is dependent on that function. 14 basic functions are evaluated throughout the test and the scores given to the patient are collected at the end of the test. As a result, the person evaluated receives a score between 0-56. Scores between 0-20 indicate balance disorder, scores between 21-40 indicate that the balance is acceptable, and scores between 41-56 indicate that the balance is good.

  12 weeks

Secondary Outcomes (1)

• Fatigue Severity Scale

  12 weeks

Other Outcomes (2)

• Rivermead Visual Walking Scale

  12 weeks

• Expanded Disability Status Scale

  12 weeks

Study Arms (3)

Virtual Reality Training Group

EXPERIMENTAL

Virtual Reality Training Procedure; In general, virtual reality training will be developed taking into account neurorehabilitation principles; Type of game and specificity (there will be exercises specific to the disease), Intensity (will be gradually increased), Progress (exercises will be gradually progressed, variability (the environment will be changed) and Feedback (visual and auditory feedback will be provided). The virtual reality training to be applied will also be fun, It will include attention and problem-solving ability. The difficulty and skill level will gradually increase in order to ensure continuity of motivation and motor learning in individuals. It will be aimed to perform the exercises at moderate to severe intensity. The intensity level of the exercises will be at moderate intensity, and the perceived effort according to the Borg Scale will be 12- It will be checked by asking for 15 points.

Other: Virtual Reality Training Group

Conventional Training Group

OTHER

Individuals in this group will continue classical physiotherapy exercises. There will be no intervention by us in the traditional training group.

Other: Conventional Training Group

Task-Oriented Training Group

EXPERIMENTAL

Task Oriented Training Procedure; Task-oriented training focusing on improving balance and walking will consist of 8 different exercise stations. Individuals will continue the exercise at each station for 4 minutes and rest for 1 minute before moving on to the next station. The training completed in this way will consist of a total of 40 minutes and the exercise stations will be applied following the determined order: The exercises will first be demonstrated by the physiotherapist. The aim is to perform exercises at moderate to vigorous intensity. It will be checked that the intensity level of the exercises is moderate and that the perceived effort is 12-15 points according to the Borg Scale. Perception of perceived exertion; It will be controlled by asking to increase the speed, changing the ground, giving double tasks and using obstacles made of wooden blocks. Individuals will be given visual and auditory positive feedback during the exercises.

Other: Task-Oriented Training Group

Interventions

Virtual Reality Training Group OTHER

Virtual Reality Training Procedure; In general, virtual reality training will be developed taking into account neurorehabilitation principles; Type of game and specificity (there will be exercises specific to the disease), Intensity (will be gradually increased), Progress (exercises will be gradually progressed, variability (the environment will be changed) and Feedback (visual and auditory feedback will be provided). The virtual reality training to be applied will also be fun, It will include attention and problem-solving ability. The difficulty and skill level will gradually increase in order to ensure continuity of motivation and motor learning in individuals. It will be aimed to perform the exercises at moderate to severe intensity. The intensity level of the exercises will be at moderate intensity, and the perceived effort according to the Borg Scale will be 12- It will be checked by asking for 15 points.

Virtual Reality Training Group

Task-Oriented Training Group OTHER

ask Oriented Training Procedure; Task-oriented training focusing on improving balance and walking will consist of 8 different exercise stations. Individuals will continue the exercise at each station for 4 minutes and rest for 1 minute before moving on to the next station. The training completed in this way will consist of a total of 40 minutes and the exercise stations will be applied following the determined order: The exercises will first be demonstrated by the physiotherapist. The aim is to perform exercises at moderate to vigorous intensity. It will be checked that the intensity level of the exercises is moderate and that the perceived effort is 12-15 points according to the Borg Scale. Perception of perceived exertion; It will be controlled by asking to increase the speed, changing the ground, giving double tasks and using obstacles made of wooden blocks. Individuals will be given visual and auditory positive feedback during the exercises.

Task-Oriented Training Group

Conventional Training Group OTHER

Individuals in this group will continue classical physiotherapy exercises. There will be no intervention by us in the traditional training group.

Conventional Training Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with benign type, relapsing remitting type multiple sclerosis.
• Individuals between the ages of 20-65.
• Being between levels 0-5 according to EDSS.
• Participating in the study voluntarily.

You may not qualify if:

• Having an acute MS attack,
• Participants have an orthopedic or systemic problem that would prevent them from continuing to exercise,
• Another known neuromuscular disease other than MS,
• Having high-level spasticity (Modified Ashworth Scale score of 3 or 4) in the lower extremity,
• Individuals with cardiopulmonary problems that prevent them from exercising.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu Univercity

Malatya, Central, 44050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Mobility Limitation; Fatigue; Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Burcu TALU, Associate Professor

  Advisor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: This is a randomized, parallel-group, interventional study including two active intervention arms. Participants remain in their assigned group for the duration of the study.

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: June 3, 2025
• Study Start: January 15, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 3, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)