Effect of Pilates Training in Patients With Multiple Sclerosis

Sponsor
Gazi University (Other)
Overall Status
Completed
CT.gov ID
NCT04548206
Collaborator
(none)
34
1
2
22.4
1.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pilates training
  • Other: control
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective randomize controlled studyprospective randomize controlled study
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Pilates Training on Sensory, Muscle Strength, Balance, and Gait in Patients With Multiple Sclerosis
Actual Study Start Date :
Sep 14, 2020
Actual Primary Completion Date :
Jul 29, 2022
Actual Study Completion Date :
Jul 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pilates training

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

Other: Pilates training
The program consisted of core-based Pilates exercises on the mat for 60 minutes.

Placebo Comparator: Control group

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

Other: control
The program consisted of progressive relaxation exercises at home.

Outcome Measures

Primary Outcome Measures

  1. Gait [5 minutes]

    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.

  2. Balance [10 minutes]

    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.

  3. Light touch-pressure sensation [10 minutes]

    Light touch-pressure sensation will be assessed using a full Semmes-Weinstein Monofilament (SWM) test kit (North Coast Medical, San Jose, CA, USA).

  4. Vibration sensation [10 minutes]

    Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany).

  5. Two-point discrimination [10 minutes]

    Two-point discrimination sensation of the foot sole will be evaluated using an aesthesiometer (Baseline1, White Plains, New York, USA).

  6. Position sensation of knee joint [5 minutes]

    Open kinetic chain position of both knees will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).

  7. Knee proprioception [10 minutes]

    Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).

  8. Position sensation of trunk [10 minutes]

    Position sensation of trunk will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).

  9. Knee strength [20 minutes]

    Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gazi University Ankara Turkey

Sponsors and Collaborators

  • Gazi University

Investigators

  • Principal Investigator: Cagla Ozkul, Phd, Gazi University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cagla Ozkul, Research Assistant, Gazi University
ClinicalTrials.gov Identifier:
NCT04548206
Other Study ID Numbers:
  • 166
First Posted:
Sep 14, 2020
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cagla Ozkul, Research Assistant, Gazi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022