Back to resultsThe Validity and Reliability of the Upper Extremity Exercise Testing (UULEX) in Patients With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Upper extremity endurance test (UULEX)
Sponsored by
About this trial
This is an interventional screening trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Multiple scleroisis
Exclusion Criteria:
- Presence of extreme spasticity in the upper extremities that will prevent the performing of UULEX
Sites / Locations
- Marmara University School of Medicine Department of Physical Medicine and RehabilitationRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multiple Sclerosis
Arm Description
Patients with multiple sclerosis will perform the UULEX and fill in the other mentioned parameters. Validity and reliability of the UULEX will be measured.
Outcomes
Primary Outcome Measures
Upper extremity endurance testing
Upper extremity endurance testing
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04979819
Brief Title
The Validity and Reliability of the Upper Extremity Exercise Testing (UULEX) in Patients With Multiple Sclerosis
Official Title
The Validity and Reliability of the Upper Extremity Exercise Testing (UULEX) in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Validity and Reliability
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multiple Sclerosis
Arm Type
Experimental
Arm Description
Patients with multiple sclerosis will perform the UULEX and fill in the other mentioned parameters. Validity and reliability of the UULEX will be measured.
Intervention Type
Other
Intervention Name(s)
Upper extremity endurance test (UULEX)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper extremity endurance testing
Description
Upper extremity endurance testing
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Multiple scleroisis
Exclusion Criteria:
Presence of extreme spasticity in the upper extremities that will prevent the performing of UULEX
Facility Information:
Facility Name
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozge Kenis-Coskun, MD
Phone
5058294947
Email
ozgekenis@gmail.com
First Name & Middle Initial & Last Name & Degree
MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Validity and Reliability of the Upper Extremity Exercise Testing (UULEX) in Patients With Multiple Sclerosis
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