Arm Swing During Walking in Early Multiple Sclerosis

July 26, 2023 updated by: Gokce Leblebici, Istanbul University - Cerrahpasa (IUC)

Multiple sclerosis (MS) is the most common central nervous system inflammatory demyelinating disease which causes motor and sensory deficits, cerebellar symptoms, and balance problems. Due to these symptoms, gait abnormalities are common in MS, even in patients with low degrees of impairment. The upper limb has an important role on postural control and gait stability. Affected arm swing movement and asymmetry during gait are common in neurological disorders such as Parkinson's disease (PD) even in early stages of the disease and arm swing treatment has been acknowledged to enhance gait and normalize arm swing in individuals with PD.

The presence of arm swing changes during walking in MS patients, similar to PD, especially in the early period, may be an indicator of balance problems, this was, however, not investigated as such. Therefore, the aim of the current study is to assess the arm swing during gait in people with MS shortly after their diagnosis in early MS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

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
      • Istanbul, Turkey
        • İstanbul University-Cerrahpaşa

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Eighteen MS outpatients from a hospital and 10 healthy controls were included. The patients who were diagnosed with MS in the last 30 days, were recovered from their symptoms and were clinically stable were included.

Patients who had an acute medical illness in the past 6 months, any other neurological and psychiatric diseases, and any orthopedic, rheumatologic, or vestibular conditions that affect walking were excluded. The patients who had exacerbations between the first and second evaluations (three months after the first evaluation) were excluded.

Description

Inclusion Criteria:

  • Patients who were diagnosed with MS in the last 30 days,
  • Patients who were recovered from their symptoms and were clinically stable

Exclusion Criteria:

  • Patients who had an acute medical illness in the past 6 months, any other neurological and psychiatric diseases
  • Patients who had any orthopedic, rheumatologic, or vestibular conditions that affect walking
  • Patients who had exacerbations between the first and second evaluations

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
Intervention / Treatment
Early Multiple Sclerosis
Arm swing evaluation and functional tests will be tested in this group.
Other: Evaluation of the arm swing during gait
Evaluation of the arm swing during gait: The difference between the maximum flexion and extension of the shoulder is the arm swing amplitude during walking. The arm swing amplitude will be evaluated 2-dimensionally with the help of the Kinovea video player.
Other Names:
  • Arm swing during walking
Other: Functional Tests
To understand the changes in functional mobility, Two Minute Walk Test (2MWT), Timed Up and Go (TUG) and Timed 25Foot Walk Test (T25FW) were conducted.
Other Names:
  • Two Minute Walk Test (2MWT), Timed Up and Go (TUG) and Timed 25Foot Walk Test (T25FW)
Healthy Controls
Arm swing evaluation will be tested in this group.
Other: Evaluation of the arm swing during gait
Evaluation of the arm swing during gait: The difference between the maximum flexion and extension of the shoulder is the arm swing amplitude during walking. The arm swing amplitude will be evaluated 2-dimensionally with the help of the Kinovea video player.
Other Names:
  • Arm swing during walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arm swing amplitude-shoulder degrees in flexion-extension direction
Time Frame: 3 months after the baseline
The difference between the maximum flexion and extension of the shoulder will be calculated with Kinovea video player.
3 months after the baseline
Arm swing amplitude-elbow degrees in flexion-extension direction
Time Frame: 3 months after the baseline
The difference between the maximum flexion and extension of the shoulder will be calculated with Kinovea video player.
3 months after the baseline
Arm swing amplitude-overall degrees in flexion-extension direction
Time Frame: 3 months after the baseline
The difference between the maximum flexion and extension of the shoulder will be calculated with Kinovea video player.
3 months after the baseline
Step-speed
Time Frame: 3 months after the baseline
The stepping task required patients to walk back and forth for 2 minutes over a three meters walkway which was set up with the FreeMed foot pressure analysis system (Sensor Medica, Guidonia Montecelio). Step speed outcome was collected from foot pressure analysis system.
3 months after the baseline
Two Minute Walk Test (2MWT)
Time Frame: 3 months after the baseline
It is a measure of self-paced walking ability and functional capacity. The person is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured.
3 months after the baseline
Timed Up and Go (TUG)
Time Frame: 3 months after the baseline
To determine fall risk and measure the progress of balance, sit to stand and walking.It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
3 months after the baseline
Timed 25Foot Walk Test (T25FW)
Time Frame: 3 months after the baseline
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk.
3 months after the baseline

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa (IUC)

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

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)

December 1, 2021

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulUC_MStation_armswing

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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