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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03846336
Other study ID # 25
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date September 1, 2018

Study information

Verified date February 2019
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date September 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Other:
Upper extremity function
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
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.

Locations

Country Name City State
Turkey Ankara Yildirim Beyazit University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation Ankara Esenboga

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 1 month
Secondary 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. 1 month
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