Gait Analysis in Multiple Sclerosis Patients

NCT05299151 | Completed

• 1 other identifier: VR-1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis; 3D Gait Analysis; Vestibular Rehabilitation

Keywords

gait analysis, multiple sclerosis, vestibular, kinetic, kinematic

Outcome Measures

Primary Outcomes (2)

• 3D Gait Analysis System - pre assesment

  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

  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 Outcomes (6)

• One Leg Standing Test - pre assesment

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

• One Leg Standing Test - post assessment

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

• Dizziness Handicap Inventory - pre assessment

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

• Dizziness Handicap Inventory - post assessment

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

• 2 Minute Walking Test - pre assessment

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

Study Arms (2)

Vestibular Rehabilitation Group

EXPERIMENTAL

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

Standard Neurorehabilitation Group

ACTIVE COMPARATOR

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

Interventions

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.

Vestibular Rehabilitation Group

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.

Standard Neurorehabilitation Group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Kültür University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Istanbul University - Cerrahpaşa, Vocational School of Health Services

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Comber L, Galvin R, Coote S. Gait deficits in people with multiple sclerosis: A systematic review and meta-analysis. Gait Posture. 2017 Jan;51:25-35. doi: 10.1016/j.gaitpost.2016.09.026. Epub 2016 Sep 26.

  PMID: 27693958 BACKGROUND

• Huisinga JM, Schmid KK, Filipi ML, Stergiou N. Gait mechanics are different between healthy controls and patients with multiple sclerosis. J Appl Biomech. 2013 Jun;29(3):303-11. doi: 10.1123/jab.29.3.303. Epub 2012 Aug 22.

  PMID: 22923390 BACKGROUND

• Garcia-Munoz C, Cortes-Vega MD, Heredia-Rizo AM, Martin-Valero R, Garcia-Bernal MI, Casuso-Holgado MJ. Effectiveness of Vestibular Training for Balance and Dizziness Rehabilitation in People with Multiple Sclerosis: A Systematic Review and Meta-Analysis. J Clin Med. 2020 Feb 21;9(2):590. doi: 10.3390/jcm9020590.

  PMID: 32098162 BACKGROUND

• Gunn H, Markevics S, Haas B, Marsden J, Freeman J. Systematic Review: The Effectiveness of Interventions to Reduce Falls and Improve Balance in Adults With Multiple Sclerosis. Arch Phys Med Rehabil. 2015 Oct;96(10):1898-912. doi: 10.1016/j.apmr.2015.05.018. Epub 2015 Jun 10.

  PMID: 26070975 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 28, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

TU (1)