Upper Extremity Function, Shoulder Position Sense and Disability Level İn Patients With Multiple Sclerosis

February 17, 2019 updated by: Ankara Yildirim Beyazıt University

An Investigation of Upper Extremity Function in Patients With Multiple Sclerosis, and Its Relation With Shoulder Position Sense and Disability Level

The purposes of this study is to investigate the relationship between upper extremity muscle function and shoulder position sense in patients with Multiple Sclerosis (MS) and which best projects the disability status.

Upper extremity dysfunction is considered to be the main cause of the loss performance of activities of daily living and this problem was include all motor and somatosensory components of function. Any failure in each of these components will likely create an impairment in the normal function.

One of the most important components of the somatosensory system is joint position sense, a sub-modality of proprioception. Position sense disorders are seen from the early stages of the disease and upper extremity function problems is experienced depending on position sense disorders in patients with MS.

Expanded Disability Status Scale (EDSS) is one of the most commonly outcome measures in evaluating the level of disability in MS population. Because EDSS scale emphasis on ambulation, so it is insensitive to upper extremity function. But the ability to use walking aids (e.g., canes, walkers, wheelchairs, etc.) may be affected by the UE impairment so shoulder position sense.

When literature is examined, there is no study which examines the relationship between upper extremity muscle function and shoulder position sense in patients with Multiple Sclerosis and which best projects the disability status. For all these reasons, we think that shoulder position sense is changed both dominant and non-dominant side during flexion and abduction movements in mild-moderate MS patients and that these deficits are correlated with upper extremity function and disability level.

Study Overview

Detailed Description

This study was aimed to investigate the relationship between upper extremity muscle function and shoulder position sense in patients with MS and which best projects the disability status.

21 PwMS and 20 healthy volunteers with matching ages and genders were included the study. A neurologic examination was performed using the EDSS by a neurologist.

Upper extremity function was evaluated with 9-Hole Peg Test (9-HPT). Shoulder position sense was evaluated with Dualer IQTM digital inclinometer (J-TECH medical, Salt Lake City, UK, USA).

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

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

    • Esenboğa
      • Ankara, Esenboğa, Turkey, 06970
        • Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Multiple Sclerosis Disease
  • The level of disability should be between 0.5-4 according to EDSS

Exclusion Criteria:

  • Patients with acute attacks (three months prior to the study)
  • Mini-Mental State Examination (MMSE) score of less tahn 25 points
  • History of shoulder injury, surgery, medical problems or other neurological disorders in any of the participants

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

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multiple Sclerosis
Patients with confirmed diagnosis of clinically definite MS and physician-administered EDSS range of 1-3.5.
Upper extremity function was evaluated with 9-Hole Peg Test (9-HPT). The 9-HPT is a brief, standardized, quantitative test of upper extremity function. It consists of moving nine pegs into one of the nine holes on a peg board, then back into an open box. Both the dominant and non-dominant hands are tested twice.
Shoulder position sense was evaluated with a Dualer IQTM digital inclinometer (J-TECH medical, Salt Lake City, UT, USA). The absolute error scores (in degrees) for shoulder abduction and flexion at 30° and 60° was calculated. The upper extremity of the participant was positioned with the arm in the scapular plane for the abduction movement and in the sagittal plane for the flexion movement. After returning to the starting position, participants attempted to repeat the previously attained angle. Participants indicated verbally when they felt they had reached the angle and held their position. The measurement was repeated 2 more times for a total of 3 trials for each limb (non-dominant and dominant), with a 30-second rest period separating trials.
Other: Healthy individuals
20 healthy volunteers with matching ages and genders.
Upper extremity function was evaluated with 9-Hole Peg Test (9-HPT). The 9-HPT is a brief, standardized, quantitative test of upper extremity function. It consists of moving nine pegs into one of the nine holes on a peg board, then back into an open box. Both the dominant and non-dominant hands are tested twice.
Shoulder position sense was evaluated with a Dualer IQTM digital inclinometer (J-TECH medical, Salt Lake City, UT, USA). The absolute error scores (in degrees) for shoulder abduction and flexion at 30° and 60° was calculated. The upper extremity of the participant was positioned with the arm in the scapular plane for the abduction movement and in the sagittal plane for the flexion movement. After returning to the starting position, participants attempted to repeat the previously attained angle. Participants indicated verbally when they felt they had reached the angle and held their position. The measurement was repeated 2 more times for a total of 3 trials for each limb (non-dominant and dominant), with a 30-second rest period separating trials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper extremity function
Time Frame: 1 month
Upper extremity function was evaluated with the 9-Hole Peg Test (9-HPT). It consists of moving nine pegs into one of the nine holes on a peg board, then back into an open box. A stopwatch was used for the measurements and the scores were recorded in seconds (s).
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder position sense
Time Frame: 1 month
Shoulder position sense was evaluated with a Dualer IQTM digital inclinometer (J-TECH medical, Salt Lake City, UT, USA).The absolute error scores (in degrees) for shoulder abduction and flexion at 30° and 60° was calculated. The difference between the target angle and the observed angle was calculated and the absolute error score was recorded by taking the average of 3 trials.
1 month

Collaborators and Investigators

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

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.

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)

June 1, 2018

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

February 17, 2019

First Submitted That Met QC Criteria

February 17, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 17, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

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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