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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04933110
• Other study ID #: IAÜ2
• Status: Not yet recruiting
• Start date: July 5, 2021
• Est. completion date: September 20, 2021

Study information

• Verified date: June 2021
• Source: Istanbul Aydin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 20, 2021
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ugur OVACIK	Istanbul University-Cerrahpasa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	ABILHAND	To assess for performance of activity. Score range 0-46 point, higher scores mean a better outcome.	baseline (on the predetermined assessment day)
Primary	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)
Primary	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	Hand Held Dynamometer	To assess upper extremity muscle strength. Higher scores indicate better muscle strength.	baseline (on the predetermined assessment day)
Secondary	Hand Dynamometer	To assess grip strength. Higher scores indicate better muscle strength.	baseline (on the predetermined assessment day)
Secondary	Pinchmeter	To assess pinch strength. Higher scores indicate better muscle strength.	baseline (on the predetermined assessment day)
Secondary	Tuning fork	To assess deep sense. A higher score indicates better sensitivity.	baseline (on the predetermined assessment day)
Secondary	Aesthesiometer	To assess two-point discrimination. A higher score indicates worse sensitivity.	baseline (on the predetermined assessment day)
Secondary	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)
Secondary	Symbol Digit Modalities Test	To assess cognitive level. A higher score indicates better cognitive level.	baseline (on the predetermined assessment day)
Secondary	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)