StrokeNCT05907876
Test-Retest Reliability Of UULEX In Patients With Stroke
An observational study of Stroke, run by Karabuk University.
Trial summary
Hemiplegia refers to a complete paralysis involving one side of the arm, trunk and leg. Stroke causes loss of ability and leads to loss of functionality of daily life activities of individuals. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Stroke
- What is being tested?
- Functional Test
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Dec 2023
- Phase
- Observational
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with stroke receiving rehabilitation services in a rehabilitation centre
Who may be able to join
- Having had a stroke
- Diagnosis of haemiplegia after a previous stroke
- Being between 18-78 years old
- Volunteering to participate in the study
Who cannot join
- Presence of pain in the upper limbs or neck
- Cognitive disorders
- Presence of comorbidity affecting upper extremity and hand functions (carpal tunnel syndrome, trigger finger, impingement syndrome, thoracic outlet syndrome, lateral and medial epicondylitis)
- History of upper extremity surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Karabuk University
Hemiplegia refers to a complete paralysis involving one side of the arm, trunk and leg. Stroke causes loss of ability and leads to loss of functionality of daily life activities of individuals. Changes in the anatomy of the joint should be analysed for a better understanding of upper extremity problems, especially shoulder problems and pain after stroke. In recent years, the prevalence of shoulder pain in haemiplegic patients has ranged between 5% and 84%. Shoulder pain makes movements of the upper limb difficult and affects gait. Lack of active movement and spasticity is an important cause of shoulder pain. Pain and changes in muscle tone affect upper limb functionality by 30-66%. Improvement in shoulder pain with the recovery of upper extremity functions is important in returning the person to active life independently, as well as obtaining effective hand function. There are many clinical tests used to evaluate upper extremity functionality after haemiplegia. One of them, the Unassisted Upper Extremity Exercise Test (UULEX), is a performance test that evaluates upper extremity performance. The unsupported upper extremity exercise test (UULEX) is a simple, inexpensive field test developed to measure upper arm exercise capacity, but there are no reports on its reliability for use in patients with hemiplegia. The aim of our study was to determine the test-retest reliability of the UULEX in stroke patients.
- Conditions
- Stroke
- Being tested
- Functional Test
- Keywords
- STROKE, UULEX, UPPER EXTREMITY
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional TestOther
UULEX uses a table of horizontal parallel lines with 8 levels. Each level is 84 cm wide and 8 cm high. The distance between the levels is 15 cm. The subject is seated on a straight chair with his/her feet on the floor facing the wall with the UULEX table. He/she holds a bar weighing 0.2 kg and lifts the bar at hip level. Keeping his/her arms shoulder-width apart, he/she raises the bar to different levels of the chart. As a warm-up, he/she is instructed to raise the bar to the first level and hold this position for 2 minutes. Then the bar is moved to each level and the levels are increased for 1 minute. The starting and ending point of each level is the hip joint. As the exercise progresses each minute, the weight of the bar is increased by 0.5 kg up to a maximum of 2 kg. During the test, a subject can move up to a maximum of a 2kg bar in a maximum of 12 minutes. The subject is instructed to continue the test until limited by the occurrence of symptoms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Functionality
It will be evaluated using UULEX.
Measured: First Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Hale Altınkaya, Karabuk University
- Investigators
- Fatma Hale Altınkaya, Study chair, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907876
- Sponsor's protocol ID
- KarabukUN
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Karabuk University
- ClinicalTrials.gov ID
- NCT05907876
- Acronym / sponsor ID
- KarabukUN
- Conditions
- Stroke
- Keywords
- STROKE, UULEX, UPPER EXTREMITY
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 18 Jun 2023 (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.
Hemiplegia refers to a complete paralysis involving one side of the arm, trunk and leg. Stroke causes loss of ability and leads to loss of functionality of daily life activities of individuals. Changes in the anatomy of the joint should be analysed for a better understanding of upper extremity problems, especially shoulder problems and pain after stroke. In recent years, the prevalence of shoulder pain in haemiplegic patients has ranged between 5% and 84%. Shoulder pain makes movements of the upper limb difficult and affects gait. Lack of active movement and spasticity is an important cause of shoulder pain. Pain and changes in muscle tone affect upper limb functionality by 30-66%. Improvement in shoulder pain with the recovery of upper extremity functions is important in returning the person to active life independently, as well as obtaining effective hand function. There are many clinical tests used to evaluate upper extremity functionality after haemiplegia. One of them, the Unassisted Upper Extremity Exercise Test (UULEX), is a performance test that evaluates upper extremity performance. The unsupported upper extremity exercise test (UULEX) is a simple, inexpensive field test developed to measure upper arm exercise capacity, but there are no reports on its reliability for use in patients with hemiplegia. The aim of our study was to determine the test-retest reliability of the UULEX in stroke patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with stroke receiving rehabilitation services in a rehabilitation centre
Key inclusion criteria (4 listed)
- Having had a stroke
- Diagnosis of haemiplegia after a previous stroke
- Being between 18-78 years old
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- Presence of pain in the upper limbs or neck
- Cognitive disorders
- Presence of comorbidity affecting upper extremity and hand functions (carpal tunnel syndrome, trigger finger, impingement syndrome, thoracic outlet syndrome, lateral and medial epicondylitis)
- History of upper extremity surgery
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 |
|---|---|---|
| Functional TestUULEX uses a table of horizontal parallel lines with 8 levels. Each level is 84 cm wide and 8 cm high. The distance between the levels is 15 cm. The subject is seated on a straight chair with his/her feet on the floor facing the wall with the UULEX table. He/she holds a bar weighing 0.2 kg and lifts the bar at hip level. Keeping his/her arms shoulder-width apart, he/she raises the bar to different levels of the chart. As a warm-up, he/she is instructed to raise the bar to the first level and hold this position for 2 minutes. Then the bar is moved to each level and the levels are increased for 1 minute. The starting and ending point of each level is the hip joint. As the exercise progresses each minute, the weight of the bar is increased by 0.5 kg up to a maximum of 2 kg. During the test, a subject can move up to a maximum of a 2kg bar in a maximum of 12 minutes. The subject is instructed to continue the test until limited by the occurrence of symptoms. | Other | – |
Primary outcome
Upper Limb Functionality
Time frame: First Day
It will be evaluated using UULEX.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Fatma Hale Altınkaya study chair
Karabuk University
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Karabuk University.
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 4 inclusion and 4 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Fatma Hale Altınkaya (05312013899, f.hale.altinkaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limb Functionality (time frame: First 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 22 Jun 2023.