Multiple Sclerosis Clinical Trial
Official title:
The Effect of Vestibular Rehabilitation on the Kinetic and Kinematic Parameters of Walking in Patients With Multiple Sclerosis
Verified date | December 2023 |
Source | Istanbul Kültür University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University - Cerrahpasa, Vocational School of Health Services | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul Kültür University | Istanbul University - Cerrahpasa (IUC) |
Turkey,
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
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. |
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