Investigation of Hand Functions and Related Parameters in People With Multiple Sclerosis

Sponsor

Uğur OVACIK (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04933110

Collaborator

Istanbul University-Cerrahpasa (Other)

Enrollment

2.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The upper extremity in people with Multiple Sclerosis (pwMS) has become a more popular research topic in recent years, with the increase in studies reporting widespread involvement. The aim of our study was to evaluate the upper extremity from multiple perspectives in early stage pwMS, to identify problems by comparing them with healthy individuals, and to examine the relationship of problems with activity and participation.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Investigation of Hand Functions and Related Parameters in People With Multiple Sclerosis in the Very Early Stage.

Anticipated Study Start Date :

Jul 5, 2021

Anticipated Primary Completion Date :

Sep 6, 2021

Anticipated Study Completion Date :

Sep 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Multiple Sclerosis Individuals with early-stage multiple sclerosis
Healthy Volunteers Healthy volunteers of similar age and sex as individuals with multiple sclerosis

Outcome Measures

Primary Outcome Measures

Nine Hole Peg Test [baseline (on the predetermined assessment day)]
To assess upper extremity function. Completing the test in a short time (seconds) indicates better upper extremity function.
Minnesota Manual Dexterity Test [baseline (on the predetermined assessment day)]
To assess upper extremity function. Completing the test in a short time (seconds) indicates better upper extremity function.
ABILHAND [baseline (on the predetermined assessment day)]
To assess for performance of activity. Score range 0-46 point, higher scores mean a better outcome.
Motor Activity Log-28 [baseline (on the predetermined assessment day)]
To assess for performance of activity. Score range 0-5 point, a high score indicates good upper extremity use frequency and quality of movement during activity.
Community Integration Questionnaire [baseline (on the predetermined assessment day)]
To assess participation. The total score ranges from 0-29, and the higher the score, the higher the individual's participation in society is considered.

Secondary Outcome Measures

Hand Held Dynamometer [baseline (on the predetermined assessment day)]
To assess upper extremity muscle strength. Higher scores indicate better muscle strength.
Hand Dynamometer [baseline (on the predetermined assessment day)]
To assess grip strength. Higher scores indicate better muscle strength.
Pinchmeter [baseline (on the predetermined assessment day)]
To assess pinch strength. Higher scores indicate better muscle strength.
Tuning fork [baseline (on the predetermined assessment day)]
To assess deep sense. A higher score indicates better sensitivity.
Aesthesiometer [baseline (on the predetermined assessment day)]
To assess two-point discrimination. A higher score indicates worse sensitivity.
Fatigue Severity Scale [baseline (on the predetermined assessment day)]
To assess the severity of fatigue. Score range 1-7 point, a higher score indicates more severe fatigue.
Symbol Digit Modalities Test [baseline (on the predetermined assessment day)]
To assess cognitive level. A higher score indicates better cognitive level.
Hospital Anxiety and Depression Scale [baseline (on the predetermined assessment day)]
To assess anxiety and depression. The total score ranges from 0 to 21 for each of the two subscales. A higher score indicates more severe anxiety and depression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

MS diagnosis according to McDonald criteria
Relapsing Remitting MS clinical course type
18-65 age range
Being able to understand and read Turkish

Exclusion Criteria:

Having an MS attack in the last 3 months
To have done regular exercise for the upper extremity in the 6 months before starting the study
Having different neurological, orthopedic or cardiac problems other than MS
Being addicted to alcohol or drugs
Getting a score below 24 on the Mini Mental Test Scale
Having a spasticity of 3 or more according to the Modified Ashworth Scale