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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Anticipated): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individuals with MS who met the inclusion criteria and volunteered to participate in the study.

Volunteer healthy individuals of similar age and sex with individuals with MS.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Multiple Sclerosis; Individuals with early-stage multiple sclerosis
Healthy Volunteers; Healthy volunteers of similar age and sex as individuals with multiple sclerosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine Hole Peg Test	To assess upper extremity function. Completing the test in a short time (seconds) indicates better upper extremity function.	baseline (on the predetermined assessment day)
Minnesota Manual Dexterity Test	To assess upper extremity function. Completing the test in a short time (seconds) indicates better upper extremity function.	baseline (on the predetermined assessment day)
ABILHAND	To assess for performance of activity. Score range 0-46 point, higher scores mean a better outcome.	baseline (on the predetermined assessment day)
Motor Activity Log-28	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.	baseline (on the predetermined assessment day)
Community Integration Questionnaire	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.	baseline (on the predetermined assessment day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Held Dynamometer	To assess upper extremity muscle strength. Higher scores indicate better muscle strength.	baseline (on the predetermined assessment day)
Hand Dynamometer	To assess grip strength. Higher scores indicate better muscle strength.	baseline (on the predetermined assessment day)
Pinchmeter	To assess pinch strength. Higher scores indicate better muscle strength.	baseline (on the predetermined assessment day)
Tuning fork	To assess deep sense. A higher score indicates better sensitivity.	baseline (on the predetermined assessment day)
Aesthesiometer	To assess two-point discrimination. A higher score indicates worse sensitivity.	baseline (on the predetermined assessment day)
Fatigue Severity Scale	To assess the severity of fatigue. Score range 1-7 point, a higher score indicates more severe fatigue.	baseline (on the predetermined assessment day)
Symbol Digit Modalities Test	To assess cognitive level. A higher score indicates better cognitive level.	baseline (on the predetermined assessment day)
Hospital Anxiety and Depression Scale	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.	baseline (on the predetermined assessment day)

Collaborators and Investigators

• Sponsor: Uğur OVACIK
• Collaborators: Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Anticipated): July 5, 2021
• Primary Completion (Anticipated): September 6, 2021
• Study Completion (Anticipated): September 20, 2021

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: multiple sclerosis; activity; participation; upper limb function
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: İAÜ2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No