Clinical trial NCT05299151: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
3D Gait Analysis
Vestibular Rehabilitation
Keywords: gait analysis, multiple sclerosis, vestibular, kinetic, kinematic
Lead sponsor: Istanbul Kültür University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2022-03-28
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.


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

Primary outcomes:
measure: 3D Gait Analysis System - pre assesment
timeFrame: 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.
measure: 3D Gait Analysis System - post assesment
timeFrame: 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:
measure: One Leg Standing Test - pre assesment
timeFrame: It will be done at the beginning of the study. The test lasts nearly 5 minutes.
measure: One Leg Standing Test - post assessment
timeFrame: It will be done at the end of the study. The test lasts nearly 5 minutes.
measure: Dizziness Handicap Inventory - pre assessment
timeFrame: It will be done at the beginning of the study. The test lasts nearly 15 minutes.
measure: Dizziness Handicap Inventory - post assessment
timeFrame: It will be done at the end of the study. The test lasts nearly 15 minutes.
measure: 2 Minute Walking Test - pre assessment
timeFrame: It will be done at the beginning of the study. The test lasts nearly 5 minutes.
measure: 2 Minute Walking Test - post assessment
timeFrame: It will be done at the end of the study. The test lasts nearly 5 minutes.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpaşa, Vocational School of Health Services
Study officials:
References:
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.
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.
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.
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.