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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04548206
Other study ID # 166
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2020
Est. completion date July 29, 2022

Study information

Verified date August 2022
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Knee flexor and extensor muscle weakness in MS patients causes a decrease in walking distance and is an important determinant of walking capacity. Exercise training has beneficial effects on muscle strength, balance, and walking in MS patients. Although the effects of aerobic and resistant exercise training in MS patients are often emphasized, today the effect of different exercise types is also wondered. Pilates is a core stability-based exercise method that improves endurance, flexibility, movement, posture, and respiratory control. The aim of this study is to examine the effect of Pilates training on sensation, muscle strength, balance, and walking in MS patients.


Description:

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) will be included in the study. The balance, gait, position sense, and muscle strength will be evaluated. The study was designed as a prospective, randomized controlled study. The patients will be randomly assigned to two groups, the "Pilates training" group, and the control group. Pilates training will be performed by the Pilates training group 2 times for 8 weeks under supervision in the outpatient clinic. The control group will be taught relaxation exercises and will be asked to perform the exercises 2 times for 8 weeks at home. Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the paired sample t-test.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 29, 2022
Est. primary completion date July 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 18-65 years of age - Having a diagnosis of "Multiple Sclerosis" - Relapse free in the last 3 mounts - Having an ambulatory status (Expanded Disability Status Scale score = 6 ) - No diagnosis of depression Exclusion Criteria: - Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates training
The program consisted of core-based Pilates exercises on the mat for 60 minutes.
control
The program consisted of progressive relaxation exercises at home.

Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Bulguroglu I, Guclu-Gunduz A, Yazici G, Ozkul C, Irkec C, Nazliel B, Batur-Caglayan HZ. The effects of Mat Pilates and Reformer Pilates in patients with Multiple Sclerosis: A randomized controlled study. NeuroRehabilitation. 2017;41(2):413-422. doi: 10.3233/NRE-162121. — View Citation

Citaker S, Gunduz AG, Guclu MB, Nazliel B, Irkec C, Kaya D. Relationship between foot sensation and standing balance in patients with multiple sclerosis. Gait Posture. 2011 Jun;34(2):275-8. doi: 10.1016/j.gaitpost.2011.05.015. Epub 2011 Jun 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Gait Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed.
Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrica.
5 minutes
Primary Balance The Modified Sensory Organization Test, which is performed using computerized posturography, measures postural sway in response to 4 different sensory conditions is measured using a force platform. 10 minutes
Primary Light touch-pressure sensation Light touch-pressure sensation will be assessed using a full Semmes-Weinstein Monofilament (SWM) test kit (North Coast Medical, San Jose, CA, USA). 10 minutes
Primary Vibration sensation Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany). 10 minutes
Primary Two-point discrimination Two-point discrimination sensation of the foot sole will be evaluated using an aesthesiometer (Baseline1, White Plains, New York, USA). 10 minutes
Primary Position sensation of knee joint Open kinetic chain position of both knees will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA). 5 minutes
Primary Knee proprioception Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA). 10 minutes
Primary Position sensation of trunk Position sensation of trunk will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA). 10 minutes
Primary Knee strength Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA). 20 minutes
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