NCT03846336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

1 month

First QC Date

February 17, 2019

Last Update Submit

February 17, 2019

Conditions

Keywords

Multiple SclerosisUpper Extremity FunctionPosition Sense

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Shoulder position sense

    1 month

Study Arms (2)

Multiple Sclerosis

EXPERIMENTAL

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

Other: Upper extremity functionOther: Shoulder position sense

Healthy individuals

OTHER

20 healthy volunteers with matching ages and genders.

Other: Upper extremity functionOther: Shoulder position sense

Interventions

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.

Healthy individualsMultiple Sclerosis

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.

Healthy individualsMultiple Sclerosis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, Esenboğa, 06970, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2019

First Posted

February 19, 2019

Study Start

June 1, 2018

Primary Completion

July 1, 2018

Study Completion

September 1, 2018

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations