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Gait Analysis in Multiple Sclerosis Patients

Primary Purpose

Multiple Sclerosis, 3D Gait Analysis, Vestibular Rehabilitation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vestibular exercises
Standard neurorehabilitation exercises
Sponsored by
Istanbul Kültür University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple Sclerosis focused on measuring gait analysis, multiple sclerosis, vestibular, kinetic, kinematic

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul University - Cerrahpaşa, Vocational School of Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vestibular Rehabilitation Group

Standard Neurorehabilitation Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
3D Gait Analysis System - post assesment
Kinetic and kinematic data of gait will be collected in the motion analysis laboratory using

Secondary Outcome Measures

One Leg Standing Test - pre assesment
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.
One Leg Standing Test - post assessment
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.
Dizziness Handicap Inventory - pre assessment
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.
Dizziness Handicap Inventory - post assessment
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.
2 Minute Walking Test - pre assessment
The distance that patients will walk for 2 minutes will be measured and recorded.
2 Minute Walking Test - post assessment
The distance that patients will walk for 2 minutes will be measured and recorded.

Full Information

First Posted
March 9, 2022
Last Updated
October 28, 2022
Sponsor
Istanbul Kültür University
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05299151
Brief Title
Gait Analysis in Multiple Sclerosis Patients
Official Title
The Effect of Vestibular Rehabilitation on the Kinetic and Kinematic Parameters of Walking in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Kültür University
Collaborators
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, 3D Gait Analysis, Vestibular Rehabilitation
Keywords
gait analysis, multiple sclerosis, vestibular, kinetic, kinematic

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vestibular Rehabilitation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Neurorehabilitation Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Vestibular exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard neurorehabilitation exercises
Intervention Description
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 Outcome Measure Information:
Title
3D Gait Analysis System - pre assesment
Description
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).
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.
Title
3D Gait Analysis System - post assesment
Description
Kinetic and kinematic data of gait will be collected in the motion analysis laboratory using
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.
Secondary Outcome Measure Information:
Title
One Leg Standing Test - pre assesment
Description
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.
Time Frame
It will be done at the beginning of the study. The test lasts nearly 5 minutes.
Title
One Leg Standing Test - post assessment
Description
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.
Time Frame
It will be done at the end of the study. The test lasts nearly 5 minutes.
Title
Dizziness Handicap Inventory - pre assessment
Description
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.
Time Frame
It will be done at the beginning of the study. The test lasts nearly 15 minutes.
Title
Dizziness Handicap Inventory - post assessment
Description
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.
Time Frame
It will be done at the end of the study. The test lasts nearly 15 minutes.
Title
2 Minute Walking Test - pre assessment
Description
The distance that patients will walk for 2 minutes will be measured and recorded.
Time Frame
It will be done at the beginning of the study. The test lasts nearly 5 minutes.
Title
2 Minute Walking Test - post assessment
Description
The distance that patients will walk for 2 minutes will be measured and recorded.
Time Frame
It will be done at the end of the study. The test lasts nearly 5 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul University - Cerrahpaşa, Vocational School of Health Services
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27693958
Citation
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.
Results Reference
background
PubMed Identifier
22923390
Citation
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.
Results Reference
background
PubMed Identifier
32098162
Citation
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.
Results Reference
background
PubMed Identifier
26070975
Citation
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.
Results Reference
background

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Gait Analysis in Multiple Sclerosis Patients

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