Hypermobility, JointNCT05558202
Turkish Version of The Lower Limb Assessment Score
An observational study of Hypermobility, Joint, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Hypermobility is more than normal joint laxity, mobility, and range of motion. It is characterized by increased laxity and fragility of connective tissues. Symptoms from hypermobility can begin at any age and affect women more than men. People are at higher risk than other people. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypermobility, Joint
- What is being tested?
- Turkish validity and reliability
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2022to 30 Dec 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: - The study will be carried out by young adults and adults in the Kutahya Health Science University
Who may be able to join
- Healthy volunteers
- Aged between 18 to 35
Who cannot join
- Using assistive devices or orthoses for the upper extremity
- Surgery history of the upper extremity
- Pain located on the upper extremity in the last 6 months
- Previous trauma that might restrict normal range of motion.
- Having degenerative or inflamatuar disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Version of The Lower Limb Assessment Score : Reliability and Validity
Hypermobility is more than normal joint laxity, mobility, and range of motion. It is characterized by increased laxity and fragility of connective tissues. Symptoms from hypermobility can begin at any age and affect women more than men. People are at higher risk than other people. It is stated that hypermobility is an important factor in orthopedic injuries and diseases. Individuals with hypermobility have more frequent orthopedic complaints and the problems are usually idiopathic and chronic. Studies have reported that proprioception and musculoskeletal reflex function may be affected independently of symptoms in hypermobile individuals. Therefore, evaluating hypermobility is very important in preventing hypermobility-related problems and injuries and developing appropriate treatment methods. Although the Beighton score is the most commonly used scoring method to determine hypermobility, it may be insufficient to determine hypermobility of the lower extremities. The Lower Limb Assessment Score (LLAS) has been reported to be one of the most appropriate scoring methods for assessing lower extremity hypermobility in the literature. The aim of this study is to adapt LLAS to Turkish and measure its validity and reliability.
- Conditions
- Hypermobility, Joint
- Being tested
- Turkish validity and reliability
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish validity and reliabilityOther
- Explanation of the Turkish version of the scale.
- Translating the Turkish version of the scale into English to ensure consistency with the original scale.
- First application of scales to participants by two examiners separately.
- Second application of the scales to the participants by one examiner.
- Statistical analysis and scaling
What is being measured
The primary outcome is the main question the study is designed to answer.
The Lower Limb Assessment Score (LLAS)
The LLAS was designed to test the mobility of many joints of the lower limb in multiple planes of motion. These tests include passive physiological, passive accessory and active range of motion.
The LLAS is performed on both lower limbs, each providing a score to a maximum of 12.
Measured: 10 minutes
The Beighton Score
The Beighton Score is a set of manoeuvres used as the standard method of assessment for Generalised Joint Hypermobility. The Beighton score arbitrarily investigates the presence of hyperlaxity (yes = 1, no = 0) at both wrists, the fifth metacarpo-phalangeal joints, elbows, knee joints, and the lumbosacral spine. The items are summed and yield a Beighton score ranging from 0 to 9 points.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start30 Sep 2022
- Primary completion30 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobility, JointStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Afsar, Kutahya Health Sciences University
- Investigators
- Emrah Afsar, Phd, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558202
- Sponsor's protocol ID
- LLAS Study
- Status last verified
- Aug 2023
- First submitted
- 23 Sep 2022
- Last updated
- 2 Aug 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of The Lower Limb Assessment Score : Reliability and Validity
- ClinicalTrials.gov ID
- NCT05558202
- Acronym / sponsor ID
- LLAS Study
- Conditions
- Hypermobility, Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 28 Sep 2022 (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.
Hypermobility is more than normal joint laxity, mobility, and range of motion. It is characterized by increased laxity and fragility of connective tissues. Symptoms from hypermobility can begin at any age and affect women more than men. People are at higher risk than other people. It is stated that hypermobility is an important factor in orthopedic injuries and diseases. Individuals with hypermobility have more frequent orthopedic complaints and the problems are usually idiopathic and chronic. Studies have reported that proprioception and musculoskeletal reflex function may be affected independently of symptoms in hypermobile individuals. Therefore, evaluating hypermobility is very important in preventing hypermobility-related problems and injuries and developing appropriate treatment methods. Although the Beighton score is the most commonly used scoring method to determine hypermobility, it may be insufficient to determine hypermobility of the lower extremities. The Lower Limb Assessment Score (LLAS) has been reported to be one of the most appropriate scoring methods for assessing lower extremity hypermobility in the literature. The aim of this study is to adapt LLAS to Turkish and measure its validity and reliability.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- - The study will be carried out by young adults and adults in the Kutahya Health Science University
Key inclusion criteria (2 listed)
- Healthy volunteers
- Aged between 18 to 35
Key exclusion criteria (5 listed)
- Using assistive devices or orthoses for the upper extremity
- Surgery history of the upper extremity
- Pain located on the upper extremity in the last 6 months
- Previous trauma that might restrict normal range of motion.
- Having degenerative or inflamatuar disease
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 |
|---|---|---|
| Turkish validity and reliability1. Explanation of the Turkish version of the scale. 2. Translating the Turkish version of the scale into English to ensure consistency with the original scale. 3. First application of scales to participants by two examiners separately. 4. Second application of the scales to the participants by one examiner. 5. Statistical analysis and scaling | Other | – |
Primary outcome
The Lower Limb Assessment Score (LLAS)
Time frame: 10 minutes
The LLAS was designed to test the mobility of many joints of the lower limb in multiple planes of motion. These tests include passive physiological, passive accessory and active range of motion. The LLAS is performed on both lower limbs, each providing a score to a maximum of 12.
The Beighton Score
Time frame: 5 minutes
The Beighton Score is a set of manoeuvres used as the standard method of assessment for Generalised Joint Hypermobility. The Beighton score arbitrarily investigates the presence of hyperlaxity (yes = 1, no = 0) at both wrists, the fifth metacarpo-phalangeal joints, elbows, knee joints, and the lumbosacral spine. The items are summed and yield a Beighton score ranging from 0 to 9 points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Emrah Afsar, Phd principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypermobility, Joint, run by Kutahya Health Sciences 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Lower Limb Assessment Score (LLAS) (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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 2 Aug 2023.