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Completed

NCT Number: NCT05299151

Gait Analysis in Multiple Sclerosis Patients

In the literature, the results of vestibular rehabilitation treatment applied in patients with Multiple Sclerosis (MS) have been investigated in detail under the headings such as fatigue, physical activity level, and quality of life, and its effects on walking have also been tried to be examined. However, in the studies conducted, gait assessments were made through questionnaires and timed tests, and devices that provide more objective data such as 3-dimensional gait analysis were not used. Again, the effects of vestibular rehabilitation programs on dual-task were not examined in previous studies.

Therefore, the aims of our study are:

1. To determine the effect of individually designed vestibular rehabilitation exercises on the kinetic and kinematic components of walking; 2. To determine the effect of vestibular rehabilitation exercises specially designed for the person on gait parameters during cognitive and motor tasks.

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Key information

Conditions

Multiple Sclerosis 3D Gait Analysis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Vestibular Rehabilitation

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University - Cerrahpaşa, Vocational School of Health Services

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between aged 25-60 years
  • Diagnosed with MS for at least 5 years
  • Relapsing and progressive MS according to Mc Donald criteria
  • EDSS score of ≤ 3.5 ≤ 6
  • Modified Ashworth Scale < 3
  • Being eligible to work by a neurologist

Exclusion criteria

  • Having had an MS-related attack in the 3 months before the study
  • Changes in medications within 6 months prior to the study
  • To have participated in the rehabilitation program within 1 month before the study
  • Serious neurological, cardiac, pulmonary, rheumatological, audiovisual, or orthopedic disorders that limit assessments and/or intervention programs

Treatment and study plan

Vestibular exercises

Other

The vestibular exercise program basically consists of 3 groups of exercises: adaptation, substitution, and habituation exercises. It is aimed to provide vestibular adaptation with adaptation exercises. Exercises that include visual and somatosensory cues to improve gaze and postural stability constitute substitution exercises. Balance exercises can be performed with eyes open and closed, or somatosensory cues can be changed by performing them on soft ground. Removing or reducing clues allows the patient to use other systems as well. The basis of habituation exercises is the reduction of the pathological response as a result of repeated exposure to the provocative stimulus. Habituation is specific to the type, intensity, and direction of stimuli. In most cases, the movement that stimulates the pathological response is less frequently performed during daily activities and promotes compensation for the initially abnormal signal of treatment.

Standard neurorehabilitation exercises

Other

A neurorehabilitation program based on stretching, strengthening, posture, mobilization, static and dynamic balance exercises (standing on one leg, tandem, balance board, etc.) will be applied.

Primary outcomes

  1. 3D Gait Analysis System - pre assesment

    Time frame: It will be done at the beginning of the study. An analysis session lasts nearly 2 hours per patient. Evaluation of all participants will take approximately 2 months.

    Kinetic and kinematic data of gait will be collected in the motion analysis laboratory using 6 infrared digital cameras (Vantage 5.0), 2 synchronized video cameras (Vicon Vue) and 2 force platforms (AMTI).

  2. 3D Gait Analysis System - post assesment

    Time frame: It will be done at the end of the study. An analysis session lasting nearly 2 hours per patient. Evaluation of all participants will take approximately 2 months.

    Kinetic and kinematic data of gait will be collected in the motion analysis laboratory using

Secondary outcomes

  1. One Leg Standing Test - pre assesment

    Time frame: It will be done at the beginning of the study. The test lasts nearly 5 minutes.

    It will be used to determine the patient's standing balance. The duration of standing on one leg will be recorded with a stopwatch and 3 repetitions will be taken and the most successful score will be used in the analysis.

  2. One Leg Standing Test - post assessment

    Time frame: It will be done at the end of the study. The test lasts nearly 5 minutes.

    It will be used to determine the patient's standing balance. The duration of standing on one leg will be recorded with a stopwatch and 3 repetitions will be taken and the most successful score will be used in the analysis.

  3. Dizziness Handicap Inventory - pre assessment

    Time frame: It will be done at the beginning of the study. The test lasts nearly 15 minutes.

    The Dizziness Disability Inventory consists of 25 items that determine the aggravating factors of patients' dizziness and balance disorder, as well as emotional and functional outcomes in vestibular system diseases. It includes 9 items that determine emotional and functional status, and seven items that determine physical function.

  4. Dizziness Handicap Inventory - post assessment

    Time frame: It will be done at the end of the study. The test lasts nearly 15 minutes.

    The Dizziness Disability Inventory consists of 25 items that determine the aggravating factors of patients' dizziness and balance disorder, as well as emotional and functional outcomes in vestibular system diseases. It includes 9 items that determine emotional and functional status, and seven items that determine physical function.

  5. 2 Minute Walking Test - pre assessment

    Time frame: It will be done at the beginning of the study. The test lasts nearly 5 minutes.

    The distance that patients will walk for 2 minutes will be measured and recorded.

  6. 2 Minute Walking Test - post assessment

    Time frame: It will be done at the end of the study. The test lasts nearly 5 minutes.

    The distance that patients will walk for 2 minutes will be measured and recorded.

Sponsors and collaborators

Lead sponsor

Istanbul Kültür University

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Official study title

The Effect of Vestibular Rehabilitation on the Kinetic and Kinematic Parameters of Walking in Patients With Multiple Sclerosis

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2022
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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