- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03846336
Upper Extremity Function, Shoulder Position Sense and Disability Level İn Patients With Multiple Sclerosis
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Esenboğa
-
Ankara, Esenboğa, Turkey, 06970
- Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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