Respiratory Functions, Trunk Control and Mobility Evaluation in Multiple Sclerosis

August 5, 2019 updated by: MELIKE SUMEYYE CENGIZ, Hacettepe University

Investigation of the Effects of Respiratory Functions and Trunk Control on Functional Mobility in Individuals With Multiple Sclerosis

Respiratory functions and body control are affected in patients with multiple sclerosis (MS). Because of this effect, the dependency of individuals increases in daily living activities and their quality of life decreases.

We think that respiratory functions, respiratory muscle strength and trunk control affect vital mobility as well as vital importance for individuals with MS. As a result of the investigations, it is concluded that the literature is insufficient in this area.

The aim of this study is to investigate the effects of pulmonary function, respiratory muscle strength and trunk control on functional mobility in individuals with MS and compare with healthy individuals.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

MS patients who are ambulatory

Healthy volunteer individuals of similar age and sex to patients

Description

Inclusion Criteria:

  • 18-65 years old
  • Having a definite MS diagnosis
  • Up to 5.5 points on the Scored Disability Status Scale (EDSS)
  • In the last 3 months have not experienced an attack
  • Mini mental test score of 24 and above
  • Acceptance to participate in the study.

Exclusion Criteria:

  • Having orthopedic problems
  • The presence of other neurological problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Multiple Sclerosis
Patients with a clinically definitive diagnosis of MS, 0-5.5 Extended Disability Status Scale range.
Healthy individuals
Voluntary healthy individuals with similar age and gender

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 Minutes Walking Test
Time Frame: baseline
Two Minute Walk Test (2MWT) will be performed to evaluate functional mobility.
baseline
Timed Up and Go Test
Time Frame: baseline
Timed Up and Go Test will be performed to evaluate functional mobility.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Functions Test
Time Frame: baseline
Challenging vital capacity (FVC), forced expiratory volume in one second (FEV₁), forced expiratory volume in one second to forced vital capacity (FEV₁/FVC), peak flow rate (PEF), forced vital capacity 25-75% speed (FEF25-75%) will be measured by portable spirometry (Spirolab, Medical International Research, Rome, Italy).
baseline
Respiratory Muscle Strength
Time Frame: baseline
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device (Micro Medical MicroMPM, UK).
baseline
Trunk Impairment Scale
Time Frame: baseline
Trunk impairment scale assesses static and dynamic sitting balance and trunk coordination. The maximum scores on the static sitting balance, dynamic sitting balance, and coordination subscales are 7, 10, and 6 points, respectively. The total score of Trunk impairment scale ranges between 0 and 23 points, with a higher score representing better trunk control.
baseline
Side Bridge Test (core muscles endurance)
Time Frame: baseline
Subjects were asked to lie on their left or right sides and extend their legs straight. Then the subjects lift their hips off the ground and form a straight line with their bodies. The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.
baseline
Modified Biering-Sorensen test (core muscles endurance)
Time Frame: baseline
During the test, the subjects are placed in an exercise bed that extends outwardly from the leading edge of the upper body and ensures that the upper iliac spine is flush with the bench edge. Subjects are asked to raise their arms while maintaining body positions.Measurements are recorded in seconds with a stopwatch. The tests will end when the subjects break the test positions.
baseline
Trunk Flexion Test (core muscles endurance)
Time Frame: baseline
Individuals are positioned in such a way that the body is at 60º, knees and hip at a flexion position of 90º. The evaluating physiotherapist supports the feet and fixes the feet on the floor. The measurements are recorded with a chronometer as seconds. The test is terminated when the 60 ° trunk flexion is impaired.
baseline
Prone bridge test (core muscles endurance)
Time Frame: baseline
During the test, the subjects place their elbows on the floor as their starting position and open their feet around the width of their thighs. They keep their body straight without bending over their elbows and toes.The measurements are recorded with a chronometer as seconds. The tests end when the subjects break the test positions.
baseline
Sit-ups Test (core muscles power)
Time Frame: baseline
The test is initiated when the subjects are told "start" and they are asked to flex their upper body up from the floor lifting the lower corner of the scapula from the floor.It is recorded how many times the subjects can perform each test for 30 seconds.
baseline
Modified Push-ups Test (core muscles power)
Time Frame: baseline
In the push-ups test, the subjects are required to push their lower body until their elbows reach a 90° angle. They are then asked to extend their arms straight to return to the starting position.It is recorded how many times the subjects can perform each test for 30 seconds.
baseline
Lumbopelvic Stability Test
Time Frame: baseline
Lumbopelvic stability is assessed using a stabilizer Pressure Biofeedback UnitTM (Chattanooga, Australia). With the participant lying supine on a plinth, the cushion is inflated underneath the participant's lumbar spine to 40 mmHg. Prior to testing, all participants are instructed in the "abdominal hollowing" manoeuvre that activates Transversus Abdominis muscle, and told to perform and continue the contraction this during subsequent lumbopelvic stability testing while attempting to minimize contraction of rectus abdominis. Scores are recorded as the highest level completed (0-5) with a pressure change no greater than 10 mmHg.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

KARMUTLU
MATUNCER
EÇKÜTÜKÇÜ

Investigators

  • Principal Investigator: MELIKE S CENGİZ, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 4, 2019

Primary Completion (ACTUAL)

July 26, 2019

Study Completion (ACTUAL)

August 2, 2019

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (ACTUAL)

February 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Assesment in MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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