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Effect of Pilates Training in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates training
control
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, sensation, gait, Pilates

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pilates training

Control group

Arm Description

60 minutes of Pilates training will be performed for 8 weeks.

The control group will be taught relaxation exercises and will be asked to perform the exercises at home.

Outcomes

Primary Outcome Measures

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.
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.
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).
Vibration sensation
Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany).
Two-point discrimination
Two-point discrimination sensation of the foot sole will be evaluated using an aesthesiometer (Baseline1, White Plains, New York, USA).
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).
Knee proprioception
Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).
Position sensation of trunk
Position sensation of trunk will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).
Knee strength
Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).

Secondary Outcome Measures

Full Information

First Posted
September 7, 2020
Last Updated
August 4, 2022
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04548206
Brief Title
Effect of Pilates Training in Patients With Multiple Sclerosis
Official Title
Effect of Pilates Training on Sensory, Muscle Strength, Balance, and Gait in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
July 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

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
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, sensation, gait, Pilates

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomize controlled study
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates training
Arm Type
Experimental
Arm Description
60 minutes of Pilates training will be performed for 8 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The control group will be taught relaxation exercises and will be asked to perform the exercises at home.
Intervention Type
Other
Intervention Name(s)
Pilates training
Intervention Description
The program consisted of core-based Pilates exercises on the mat for 60 minutes.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
The program consisted of progressive relaxation exercises at home.
Primary Outcome Measure Information:
Title
Gait
Description
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.
Time Frame
5 minutes
Title
Balance
Description
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.
Time Frame
10 minutes
Title
Light touch-pressure sensation
Description
Light touch-pressure sensation will be assessed using a full Semmes-Weinstein Monofilament (SWM) test kit (North Coast Medical, San Jose, CA, USA).
Time Frame
10 minutes
Title
Vibration sensation
Description
Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany).
Time Frame
10 minutes
Title
Two-point discrimination
Description
Two-point discrimination sensation of the foot sole will be evaluated using an aesthesiometer (Baseline1, White Plains, New York, USA).
Time Frame
10 minutes
Title
Position sensation of knee joint
Description
Open kinetic chain position of both knees will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).
Time Frame
5 minutes
Title
Knee proprioception
Description
Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).
Time Frame
10 minutes
Title
Position sensation of trunk
Description
Position sensation of trunk will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).
Time Frame
10 minutes
Title
Knee strength
Description
Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cagla Ozkul, Phd
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21683600
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.
Results Reference
background
PubMed Identifier
28946576
Citation
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.
Results Reference
background

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Effect of Pilates Training in Patients With Multiple Sclerosis

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