Gait Analysis in Multiple Sclerosis Patients

July 8, 2024 updated by: Gamze Ertürk, Istanbul Kültür University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • 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 Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University - Cerrahpaşa, Vocational School of Health Services

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

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vestibular Rehabilitation Group
A vestibular rehabilitation exercise program, which is determined based on the literature and personalized according to the functional disabilities of each patient, will be applied to the participants in the experimental group. An exercise session will be performed for a total of 40 minutes, with each exercise for 1-2 minutes. Exercise training will be applied 2 days a week for 8 weeks and they will be asked to do it at home once a week.
Other: Vestibular exercises
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.
Active Comparator: Standard Neurorehabilitation Group
A neurorehabilitation program based on stretching, strengthening, posture, mobilization, static and dynamic balance exercises will be applied. Each training session will be 40 minutes in total. Exercise training will be done in the clinical setting 2 days a week for 8 weeks, and they will be asked to do it at home once a week.
Other: Standard neurorehabilitation exercises
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
It will be done at the beginning of the study. The test lasts nearly 5 minutes.
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.
It will be done at the end of the study. The test lasts nearly 5 minutes.
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.
It will be done at the beginning of the study. The test lasts nearly 15 minutes.
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.
It will be done at the end of the study. The test lasts nearly 15 minutes.
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.
It will be done at the beginning of the study. The test lasts nearly 5 minutes.
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.
It will be done at the end of the study. The test lasts nearly 5 minutes.

Collaborators and Investigators

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

Sponsor

Istanbul Kültür University

Collaborators

Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 1, 2022

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VR-1

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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