NCT04933110

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 14, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

July 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 14, 2021

Last Update Submit

June 22, 2021

Conditions

Keywords

multiple sclerosisupper limb functionactivityparticipation

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (8)

  • Hand Held Dynamometer

    baseline (on the predetermined assessment day)

  • Hand Dynamometer

    baseline (on the predetermined assessment day)

  • Pinchmeter

    baseline (on the predetermined assessment day)

  • Tuning fork

    baseline (on the predetermined assessment day)

  • Aesthesiometer

    baseline (on the predetermined assessment day)

  • +3 more secondary outcomes

Study Arms (2)

Multiple Sclerosis

Individuals with early-stage multiple sclerosis

Healthy Volunteers

Healthy volunteers of similar age and sex as individuals with multiple sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, PT, Msc

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 21, 2021

Study Start

July 5, 2021

Primary Completion

September 6, 2021

Study Completion

September 20, 2021

Last Updated

June 25, 2021

Record last verified: 2021-06