Multiple SclerosisNCT04979819
The Validity and Reliability of the Upper Extremity Exercise Testing (UULEX) in Patients With Multiple Sclerosis
A study testing Upper extremity endurance test (UULEX) in people with Multiple Sclerosis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Upper extremity endurance test (UULEX)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Multiple scleroisis
Who cannot join
- Presence of extreme spasticity in the upper extremities that will prevent the performing of UULEX
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34899
Ozge Kenis-Coskun, MD, 5058294947, ozgekenis@gmail.com
MD
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Upper extremity endurance test (UULEX)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper extremity endurance test (UULEX)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Upper extremity endurance test (UULEX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity endurance testing
Upper extremity endurance testing
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Jul 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Validity and Reliability
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979819
- Sponsor's protocol ID
- 2021.770
- Status last verified
- Jul 2021
- First submitted
- 27 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of the Upper Extremity Exercise Testing (UULEX) in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04979819
- Acronym / sponsor ID
- 2021.770
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Validity and Reliability
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | Experimental | Other: Upper extremity endurance test (UULEX)Patients with multiple sclerosis will perform the UULEX and fill in the other mentioned parameters. Validity and reliability of the UULEX will be measured. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Multiple scleroisis
Key exclusion criteria (1 listed)
- Presence of extreme spasticity in the upper extremities that will prevent the performing of UULEX
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper extremity endurance test (UULEX)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. | Other | Multiple Sclerosis |
Primary outcome
Upper extremity endurance testing
Time frame: 1 day
Upper extremity endurance testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper extremity endurance test (UULEX) in people with Multiple Sclerosis, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity endurance testing (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.