Gait Analysis in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05299151
• Other study ID #: VR-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2023
• Source: Istanbul Kültür University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: August 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Vestibular Rehabilitation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University - Cerrahpasa, Vocational School of Health Services	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Kültür University	Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	It will be done at the beginning of the study. The test lasts nearly 5 minutes.
Secondary	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.	It will be done at the end of the study. The test lasts nearly 5 minutes.
Secondary	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.	It will be done at the beginning of the study. The test lasts nearly 15 minutes.
Secondary	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.	It will be done at the end of the study. The test lasts nearly 15 minutes.
Secondary	2 Minute Walking Test - pre assessment	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.
Secondary	2 Minute Walking Test - post assessment	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.