Effects of Balance Exercises Performed With Different Visual Stimuli

April 24, 2024 updated by: Gülsena Utku, Halic University

Comparison of the Effects of Balance Exercises Performed With Different Visual Stimuli in Individuals With Multiple Sclerosis

The study aims to examine the effects of balance exercises applied with different visual stimuli on individuals with MS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study aims to examine the effects of balance exercises applied with virtual reality glasses, stroboscopic glasses, and visual-based metaphor imaginary on individuals with MS, on their balance functions, coordination skills, and quality of life, and to compare these exercises with both traditional balance exercises, and compare each of them on motor learning, based on their effects on representational areas in the brain, and balance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Eyüpsultan
      • Istanbul, Eyüpsultan, Turkey
        • Halic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ages of 18-50
  • diagnosis of MS by a neurologist according to McDonald 2017 criteria (Carroll, 2018)
  • Being between 2.5 and 4.5 on the Expanded Disability Status Scale (EDSS)
  • Not having had an attack in the last 3 months
  • Absence of spasticity severe enough to affect treatment (spasticity in any joint of the upper extremity and lower extremity is <2 according to the Modified Ashworth Scale)
  • Getting ≥ 24 points from the Standardized Mini Mental Test (SMMT)

Exclusion Criteria:

  • hearing or vision problems
  • pregnancy
  • Having changed medication in the last 3 months and using medication containing the active ingredient Fampridine
  • Participating or participating in a regular physiotherapy and rehabilitation program in the last 3 months
  • other accompanying neurological, orthopedic or vestibular disorders
  • an upper or lower extremity contracture that prevents exercises
  • History of epileptic seizure, migraine or vertigo attack in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Balance Games with Virtual Reality Glasses
Individuals with MS in the first group will play balance games with virtual reality glasses for 15 minutes. Three different progressive games will be determined according to the functional level of the individual. Each game offers different gradually increasing difficulty levels and time options.
Other: Balance exercises with Virtual Reality Glasses
Balance exercises with Virtual Reality Glasses
Experimental: Balance Exercises with Stroboscopic Glasses
Individuals with MS in the second group will be given balance exercises with stroboscopic glasses for 15 minutes. Exercises will be selected in accordance with the functional level of the individual and will progress according to the individual's condition. In each session, 3-5 different exercises will be performed, taking into account the functional status of the individual.
Other: Balance Exercises with Stroboscopic Glasses
Balance Exercises with Stroboscopic Glasses
Experimental: Balance Exercises with Visual-Based Metaphor Training
Individuals with MS in the third group will be given balance exercises simultaneously with metaphor training using various visuals for 15 minutes. The images will be projected on the screen in front of the individuals and the individuals will be given the command: "Imagine the movement you are doing as in the image." Meanwhile, reinforcers deemed necessary will be used by the researcher physiotherapist to increase the patient's participation and motivation. Static balance exercises in the program will be performed first on stable surfaces and then on unstable surfaces. In each session, 3-5 different exercises will be performed, taking into account the functional status of the individual. The difficulty levels of the exercises will progress by adjusting according to the functional status of the individual.
Other: Balance Exercises with Visual-Based Metaphor Training
Balance Exercises with Visual-Based Metaphor Training
Active Comparator: Traditional Balance Exercises
Individuals with MS in the fourth group will be given balance exercises for 15 minutes under the supervision of a researcher physiotherapist. Exercises will be selected in accordance with the functional level of the individual and will progress according to the individual's condition. In each session, 3-5 different exercises will be performed, taking into account the functional status of the individual.
Other: Traditional Balance Exercises
Traditional Balance Exercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Near Infrared Ray Spectroscopy (fNIRS)
Time Frame: Baseline and end of the 8th week
Functional near-infrared spectroscopy is a device used to evaluate brain functions in the cerebral cortex. This device is an optical brain imaging method that measures the blood oxygenation level-dependent (BOLD) response of brain tissues. With this method, relative changes in regional brain oxygenation in the part thought to be associated with brain activation can be determined. In our study, Artinis Brite Lite® fNIRS systems will be used. The system consists of a wearable soft head and has 10 channels. In the evaluation procedure, a trial session will be conducted before the actual measurement, during which the subjects will be fitted with an fNIRS headset. The balance tasks to be evaluated will consist of right and left weight transfer, standing with two feet together, standing on one leg, tandem walking, turning from right to left/left to right, jumping in place and jumping over obstacles (Sathe et al., 2023).
Baseline and end of the 8th week
Timed Up and Go Test
Time Frame: Baseline and end of the 8th week
It is an assessment tool with strong evidence for its validity as a measure of functional mobility in individuals with MS ( Sebastiao et al., 2016 ).
Baseline and end of the 8th week
Functional Reach Test
Time Frame: Baseline and end of the 8th week
It is an easily applicable dynamic balance measurement technique that has features similar to functional movements. Distances below 15 cm have been found to be associated with an increased risk of falling (Weiner et al., 1992).
Baseline and end of the 8th week
Berg Balance Scale
Time Frame: Baseline and end of the 8th week
Berg Balance Scale is a scale that is widely used to evaluate balance disorders in multiple sclerosis patients (Berg et al., 1989), provides information about the patient's balance function, and is used to evaluate post-rehabilitation improvements (Gervasoni et al., 2016). The scale consists of 14 items for monitoring performance. Each item is scored between 0 and 4; A high score indicates good balance.
Baseline and end of the 8th week
Timed 25 Step Walking Test
Time Frame: Baseline and end of the 8th week
It will be used to evaluate the walking speed of individuals. In Z25YT, which evaluates lower extremity function, patients are asked to walk a distance of 7.62 m as quickly as possible, but without running and safely, and the completion time is recorded in seconds.
Baseline and end of the 8th week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lower Extremity Motor Coordination Test
Time Frame: Baseline and end of the 8th week
This test was developed by Desrosiers et al. to evaluate the lower extremity motor coordination skills of patients with a history of stroke, low back pain and surgery. Developed by. The test begins with the individual sitting on a chair with the knees and ankles at a 90-degree angle. Two red targets with a diameter of 6 cm are placed in front of it, distally and proximally, on a 55x50x0.4 cm mat, with 19 specific localization dimensions. The individual is asked to touch the target closest to the big toe as quickly and smoothly as possible. The number of movements made repetitively, smoothly and as fast as possible within 20 seconds is recorded (Desrosiers et al., 2005).
Baseline and end of the 8th week
Fatigue Severity Scale
Time Frame: Baseline and end of the 8th week
It is a scale consisting of 9 questions that evaluates fatigue. Each item is scored between 0 and 7. The total score is calculated by taking the arithmetic average of the scores. A score <4 is interpreted as no fatigue, and a score ≥4 as fatigue (Whitehead, 2009). The Turkish validity and reliability study of the scale was conducted by Armutlu et al., (Armutlu et al., 2007).
Baseline and end of the 8th week
Quality of Life in Multiple Sclerosis Patients
Time Frame: Baseline and end of the 8th week
Multiple Sclerosis Quality of Life Scale-54 was developed in 1995 by Vickrey et al. It was developed by (Vickrey et al., 1995); Turkish validity and reliability study by İdiman et al. Made by. The scale examines individuals' health-related quality of life levels with Likert-type scoring in a total of 54 questions prepared specifically for MS disease. Scoring varies between 0-100, with a higher score indicating a better quality of life (İdiman et al., 2006).
Baseline and end of the 8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Halic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biruni University
Istanbul University - Cerrahpasa (IUC)
Fenerbahce University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: GÜLSENA UTKU UMUT, Halic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS and Balance

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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