NCT04979819

Brief Summary

Multiple sclerosis negatively affects the endurance and functionality in the upper extremities. 20 female patients aged 18-70 years who were diagnosed with MS will be included in the study. Demographic, family, cigarette alcohol use, etc. information will be obtained from the patients and the study will begin. Timed 25-Step Walking Test, upper extremity endurance with UULEX, Hand-Shoulder and Arm Problems Questionnaire (DASH) and Nine-hole Board Test (DDTT) evaluation were performed on the patients. Manual muscle test for muscle strength, handheld dynamometer handheld Grip strength will be measured with a dynamometer and spasticity will be measured with the Ashworth scale. Depression status of the patients will be determined by the Beck depression scale, and the presence of dyspnea will be determined by the dyspnea scale. The validity and reliability of the Unsupported Upper Extremity Exercise Test (UULEX) will be investigated with the obtained data. In order to give the most accurate result of the test in adults over 65 years of age, 3 repetitions will be performed with a resting period of half an hour. Limitation of activities of daily living will be evaluated with MSQOL-54 specific to Multiple Sclerosis. Intraclass correlation coefficient (ICC) will be used to determine test-retest reliability.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

July 27, 2021

Last Update Submit

July 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Upper extremity endurance testing

    Upper extremity endurance testing

    1 day

Study Arms (1)

Multiple Sclerosis

EXPERIMENTAL

Patients with multiple sclerosis will perform the UULEX and fill in the other mentioned parameters. Validity and reliability of the UULEX will be measured.

Other: Upper extremity endurance test (UULEX)

Interventions

Patients will lift 5 bars consecutively rhythmically until they feel fatigued. The bars will weigh 200 grs 500 gr 1kgs and 2 kgs respectively. The duration of the test will be measured to determine the endurance levels of the patients.

Multiple Sclerosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Multiple scleroisis

You may not qualify if:

  • Presence of extreme spasticity in the upper extremities that will prevent the performing of UULEX

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

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
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Validity and Reliability
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

July 28, 2021

Study Start

July 1, 2021

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations