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Completed

NCT Number: NCT03597451

The Effects of Muscles Strength on Physical Performance in Patients With Multiple Sclerosis

Muscle weakness, which is one of the most common symptoms in patients with MS, limits the activities of daily life activities of patients by causing balance and gait disturbance. Lower extremity muscle strengths of MS patients are reported to be weaker than healthy individuals. Broekmans et al. showed that the weakness of the knee flexor and extensor muscles in patients with MS caused a decrease in walking distance and they are important determinants of walking capacity.

The effects of the endurance and strength of core muscles, as well as the extremity muscles, are important on physical performance. The weakness of the extremities and core muscles in MS patients also affects the sit-to-stand performance negatively as well as a decrease in walking speed and capacity.

In this study, it was aimed to investigate the effects of extremity and core muscle strength on walking and sitting-up performance of MS patients.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The strength of the extremity and core muscles, walking capacity, and sit-to-stand performance will be evaluated once.

Investigators will use descriptive statistics and t-tests to compare variables between groups. Investigators will examine the correlations between variables using Pearson bivariate correlations. The significance level is set at p<0,05

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who 18-65 years of age
  • MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.

Exclusion criteria

  • Participants who have orthopedic, vision, hearing, or perception problems

Treatment and study plan

Primary outcomes

  1. strength of extremity muscles

    Time frame: baseline

    The isometric strength of lower extremity muscles will be assessed respectively using a hand-held dynamometer (Baseline®, White Plains, New York, USA).

Secondary outcomes

  1. 6 minutes walking test

    Time frame: baseline

    The Six-Minute Walking Test (6MWT) was performed to determine walking capacity.

  2. timed up and go test

    Time frame: baseline

    Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again.

  3. sit-to-stand test

    Time frame: baseline

    In this test, the participants will stand up from and sit down on 43 cm high armless chair as quickly as possible 5 times.

  4. Side Bridge Test (core muscles endurance)

    Time frame: baseline

    The subjects were asked to lay on their left or right sides and to extend their legs fully. Then The subjects are asked to create a straight line with their body by lifting their hip from the floor.The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.

  5. Modified Biering-Sorensen test (core muscles endurance)

    Time frame: baseline

    In this test, the subjects are asked to lie down on a workout bench, aligning their anterior superior iliac spine with the edge of the bench, which allowed the upper body to be planked out over the edge. The subjects are asked to fold their arms on their chest and to put their hands on their shoulders. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.

  6. Trunk Flexion Test (core muscles endurance)

    Time frame: baseline

    This test is initiated when the subjects are in a sit-up position with their back resting against a wedge that was angled 55° from the floor. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.

  7. Prone bridge test (core muscles endurance)

    Time frame: baseline

    In this test, the subjects put their elbows on the ground as the starting position and open their feet about the width of their hips while keeping their body straight as they are required not to arch or bow. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

The Effects of Extremity and "Core" Muscles Strength on Walking and Sit-to-Stand Performance in Patients With Multiple Sclerosis

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2018
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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