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

Primary Purpose

Physical Therapy, Upper Extremity Function, Position Sense

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Upper extremity function
Shoulder position sense
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Physical Therapy focused on measuring Multiple Sclerosis, Upper Extremity Function, Position Sense

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Multiple Sclerosis

Healthy individuals

Arm Description

Patients with confirmed diagnosis of clinically definite MS and physician-administered EDSS range of 1-3.5.

20 healthy volunteers with matching ages and genders.

Outcomes

Primary Outcome Measures

Upper extremity function
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).

Secondary Outcome Measures

Shoulder position sense
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.

Full Information

First Posted
February 17, 2019
Last Updated
February 17, 2019
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT03846336
Brief Title
Upper Extremity Function, Shoulder Position Sense and Disability Level İn Patients With Multiple Sclerosis
Official Title
An Investigation of Upper Extremity Function in Patients With Multiple Sclerosis, and Its Relation With Shoulder Position Sense and Disability Level
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Therapy, Upper Extremity Function, Position Sense
Keywords
Multiple Sclerosis, Upper Extremity Function, Position Sense

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple Sclerosis
Arm Type
Experimental
Arm Description
Patients with confirmed diagnosis of clinically definite MS and physician-administered EDSS range of 1-3.5.
Arm Title
Healthy individuals
Arm Type
Other
Arm Description
20 healthy volunteers with matching ages and genders.
Intervention Type
Other
Intervention Name(s)
Upper extremity function
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Shoulder position sense
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper extremity function
Description
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).
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Shoulder position sense
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
City
Ankara
State/Province
Esenboğa
ZIP/Postal Code
06970
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
31393220
Citation
Unluer NO, Ozkan T, Yasa ME, Ates Y, Anlar O. An investigation of upper extremity function in patients with multiple sclerosis, and its relation with shoulder position sense and disability level. Somatosens Mot Res. 2019 Sep;36(3):189-194. doi: 10.1080/08990220.2019.1644998. Epub 2019 Aug 8.
Results Reference
derived

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

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