Joint HypermobilityNCT07476976
Characteristics of the Functional State of the Musculoskeletal System, Body Awareness, and Quality of Life in Individuals With Joint Hypermobility, Their Associations, and Guidelines for Intervention.
An observational study of Joint Hypermobility, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The goal of this observational study is to learn about the characteristics of the functional state of the musculoskeletal system, body awareness, and quality of life in individuals with joint hypermobility, their associations, and guidelines for intervention.The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 20 to 100 monthsHealthy volunteers can take part
- Conditions the study is for
- Joint Hypermobility
- How many people
- 511 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Feb 2026to 1 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 100 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: First stage of the study (cultural adaptation of the five-part questionnaire and the Bristol Impact of Hypermobility Questionnaire): women and men aged 20 and over who voluntarily agreed to participate in the study. Second stage of the study: women aged 20 to 40 who voluntarily agree to participate in the study. Depending on their Beighton score and Five-Part Questionnaire score, the subjects will be divided into a study group (women with joint hypermobility: 5 or more points on the Beighton scale; 2 or more points on the Five-Part Questionnaire) and a control group (women without joint hypermobility: less than 5 points on the Beighton scale; less than 2 points on the Five-Part Questionnaire).
Who may be able to join
- First stage of the study (cultural adaptation of the five-part questionnaire and the Bristol Impact of Hypermobility Questionnaire): women and men aged 20 and over who voluntarily agreed to participate in the study.
- Second stage of the study: women aged 20 to 40 who voluntarily agree to participate in the study. Depending on their Beighton score and Five-Part Questionnaire score, the subjects will be divided into a study group (women with joint hypermobility: 5 or more points on the Beighton scale; 2 or more points on the Five-Part Questionnaire) and a control group (women without joint hypermobility: less than 5 points on the Beighton scale; less than 2 points on the Five-Part Questionnaire).
Who cannot join
- Pregnancy and the first year after childbirth; Connective tissue diseases (e.g., Marfan syndrome, osteogenesis imperfecta); Demyelinating, inflammatory neurological diseases; Malignant tumors; Female athletes; Individuals who participate or have participated in physical activities that emphasize flexibility training; Other systemic diseases (e.g., rheumatoid arthritis, diabetes mellitus); Obesity (BMI >30 kg/m²); Menopause.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to learn about the characteristics of the functional state of the musculoskeletal system, body awareness, and quality of life in individuals with joint hypermobility, their associations, and guidelines for intervention.The main questions it aims to answer are:
- To evaluate the joint hypermobility in young women and the associated symptoms using translated, adapted, and validated Lithuanian versions of questionnaires;
- To evaluate and compare the functional characteristics of the musculoskeletal system in women with and without generalized joint hypermobility;
- To evaluate and compare the characteristics of the objective and subjective body awareness and quality of life of women with and without general joint hypermobility;
- To determine the characteristics and correlations of the functional state of the musculoskeletal system, body awareness and quality of life in subjects with general joint hypermobility;
- To develop guidelines for the management of individuals with generalized joint hypermobility within the scope of competence of a physical therapist.
The translation, cultural adaptation, and validity of the five-part Bristol Impact of Hypermobility Questionnaire will be performed. Factors that may influence the manifestation of symptomatic generalized joint hypermobility will be identified; The functional status of the musculoskeletal system, objective and subjective body awareness, characteristics, and their interrelationships will be assessed and compared in individuals with and without generalized joint hypermobility. Guidelines for intervention will be developed within the competence of a physical therapist for individuals with generalized joint hypermobility.
Read the detailed description
Criteria for inclusion in the biomedicine study.
First stage of the study (cultural adaptation of the five-part questionnaire and the Bristol Impact of Hypermobility Questionnaire): women and men aged 20 and over who voluntarily agreed to participate in the study.
Second stage of the study: women aged 20 to 40 who voluntarily agree to participate in the study. Depending on their Beighton score and Five-Part Questionnaire score, the subjects will be divided into a study group (women with joint hypermobility: 5 or more points on the Beighton scale; 2 or more points on the Five-Part Questionnaire) and a control group (women without joint hypermobility: less than 5 points on the Beighton scale; less than 2 points on the Five-Part Questionnaire).
Criteria for exclusion from biomedicine research:
Pregnancy and the first year after childbirth; Connective tissue diseases (e.g., Marfan syndrome, osteogenesis imperfecta); Demyelinating, inflammatory neurological diseases; Malignant tumors; Female athletes; Individuals who participate or have participated in physical activities that emphasize flexibility training; Other systemic diseases (e.g., rheumatoid arthritis, diabetes mellitus); Obesity (BMI >30 kg/m²); Menopause.
This study will be conducted in two stages. First, translation and adaptation of the Five-Part and Bristol Impact of Hypermobility Questionnaires for cross-cultural use. The next stage will be a prospective observational study to assess the functional status of the musculoskeletal system, body awareness and quality of life characteristics of people with generalized joint hypermobility, identify correlations and develop guidelines for intervention.
The translation and cultural adaptation of the Five Part Questionnaire and the Bristol Impact of Hypermobility Questionnaire will be carried out in accordance with the guidelines recommended by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Mapi Research Trust.
The second stage of the study is prospective and observational. During the study, the subjects will undergo anthropometric measurements of height and weight, questionnaire survey, assessment of body posture, foot pressure distribution, gait, balance, movement control, range of motion, muscle strength, interoceptive awareness, pain, fatigue, and quality of life.
The following will be conducted for the subjects:
Survey: several short surveys will be conducted. One of them will be accessible via a QR code and an active link, which will be added to the invitation to participate in the study. This short survey is designed to allow us to immediately select participants based on inclusion and exclusion criteria. Participants will complete this survey online and will be able to see if they are eligible for the study. The second survey will be conducted at the Department of Sports Medicine, and participants will complete it in paper form. This questionnaire will seek to identify the health characteristics of the subjects that are important for safe testing. The third questionnaire will be designed to identify certain lifestyle factors and characteristics of pain experienced that may be related to joint hypermobility. The questionnaire will take up to 5 minutes to complete.
Pain assessment. A digital analogy scale (DAS) will be used to assess the pain experienced by the subjects. Using the DAS, subjective pain experience will be assessed on a scale from 0 to 10, where 0 means "no pain" and the highest rating of 10 means "very severe pain." To determine the location of pain, the freely accessible human body map created by Drevin et al. in 2015 will be used, on which the researcher will mark the painful areas of the body indicated by the subject.
Height and weight measurement. The height and weight of the subjects will be assessed using Wunder C-201 medical scales. Before this measurement is taken, the subject will be asked to remove their shoes and outer clothing. The height and weight assessment will take up to 2 minutes.
Physical activity is assessed using the Baecke Physical Activity Questionnaire (original short version).
The Beighton scale will be used to assess generalized joint hypermobility: the subject will be asked to perform 9 movements, based on which will be assessed whether the subject has generalized joint hypermobility or not.
A five-part questionnaire will be used to confirm generalized joint hypermobility, during which the subject will be asked to answer five questions related to joint hypermobility in written form.
Body posture assessment: the Diers Formetric 4D system (Diers International GmbH, Schlangenbad, Germany) and APECS AL Posture Evaluation and Correction System mobile app will be used to assess body posture.
The Zebris system (Zebris Medical GmbH, Germany) will be used to assess foot pressure distribution and gait.
The range of motion of the spine and neck will be assessed using Baseline Bubble Inclinometer - 360° (NY, USA) inclinometers.
The assessment of neck and spine motion amplitudes using an inclinometer will be performed based on the methodology described in Cynthia C. Norkin and D. Joyce White (F.A. Davis) Measurement of Joint Motion: A Guide to Goniometry (2024).
The assessment of the range of motion of the shoulder and lower limb joints using a goniometer will be performed based on the methodology described in Cynthia C. Norkin and D. Joyce White (F.A. Davis) Measurement of Joint Motion: A Guide to Goniometry (2024).
The Dr. Wolff BackCheck® 617 dynamometer (Dr. WOLFF Sports \& Prevention GmbH, Arnsberg, Germany) will be used to assess muscle strength.
A hydraulic hand dynamometer (Saehan®, SH5001, South Korea) will be used to measure isometric hand strength.
A multidimensional awareness questionnaire (MAIA) will be used to assess subjective body awareness.
To assess objective body awareness, balance and movement control will be evaluated using the Biodex Balance System SD (version 4.x) (NY, USA) balance assessment system.
The SF-36 quality of life questionnaire will be used to assess quality of life. Multidimensional fatigue inventory will be used the Multidimensional Fatigue Inventory (MFI) to assess the fatigue experienced by the subjects.
The data will be analyzed using Microsoft Excel 2024 and IBM SPSS 30.0 software. Parametric and non-parametric tests will be applied to compare independent samples, while correlation analysis will be used to determine relationships between variables. For the analysis of causal relationships, multiple regression analysis will be conducted. Data analyzed using parametric tests will be described as mean ± 95% confidence interval, whereas data analyzed using non-parametric tests will be described using medians and interquartile ranges. Descriptive statistical methods, correlation analysis, questionnaire reliability, and factor analysis will be applied. The significance level will be set at α = 0.05.
- Conditions
- Joint Hypermobility
- Being tested
- No intervention
- Keywords
- joint hypermobility, hypermobility spectrum disorder
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Generalized joint hypermobility group | Generalized joint hypermobility group Receives: Other: No intervention | |
| Control group | Without generalized joint hypermobility Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire survey
Several short surveys will be conducted. One of them will be accessible via a QR code and an active link, which will be added to the invitation to participate in the study. This short survey is designed to help us immediately select participants based on inclusion and exclusion criteria. Participants will complete this survey online and will be able to see whether they are eligible for the study. The second survey will be conducted at the Department of Sports Medicine, and participants will complete it in paper form. This questionnaire will seek to identify the health characteristics of the subjects that are important for safe testing. The third questionnaire will be designed to identify certain lifestyle factors and characteristics of pain experienced that may be related to joint hypermobility.
Measured: The survey will take up to 5 minutes to complete.
Five part questionnaire
Measured: Takes up to 2 minutes
Beighton score
Measured: Takes up to 5 minutes
Baecke Physical Activity questionnaire
Measured: Takes up to 5 minutes
Bristol Impact of Hypermobility questionnaire
Measured: Takes up to 10 minutes
SF-36 questionnaire
This questionnaire will be used in the cultural adaptation process of the Bristol Impact of Hypermobility questionnaire.
Measured: Takes up to 5 minutes
Secondary outcomes (9)
Numerical Rating Scale
Measured: will take up to 2 minutes
Body map
Body map by Drevin et al. for the location of pain
Measured: will take up to 2 minutes
Height and weight measurement
The height and weight of the participants will be assessed using Wunder C-201 medical scales. Before the measurement is taken, the participant will be asked to remove their shoes and take off outer clothing. The body weight of the participants will be assessed in kilograms, height in meters and centimeters, and the participants' body mass index (BMI) will be calculated.
Measured: Height and weight assessment takes up to 2 minutes.
Body posture assessment
Body posture assessment: Body posture will be evaluated using the Diers Formetric 4D system (Diers International GmbH, Schlangenbad, Germany). This non-invasive method, based on topographic principles, enables the virtual reconstruction of spinal anatomy by analyzing the structure of the back surface. During the evaluation, various parameters of the spine, pelvis, and body posture will be measured and analyzed. The results will include only quantitative posture parameter data, such as vertebral rotation in degrees and similar measurements, as well as a topographic image from the back showing trunk asymmetries.
APECS AL Posture Evaluation and Correction System mobile application: For a comprehensive body posture assessment, the APECS mobile application will also be used, as the Diers Formetric 4D system does not evaluate the posture of the neck and lower extremities.
Measured: will take up to 10 minutes
Foot pressure distribution and gait
To assess plantar pressure distribution and gait, the Zebris system (Zebris Medical GmbH, Germany) will be used. The participant will be asked to stand barefoot on a special pressure-sensitive Zebris platform. Afterwards, the participant will be asked to walk back and forth across the platform several times. During the Zebris gait analysis, the cameras capture and visualize body movements, particularly those of the lower limbs during walking. These visual data, together with the pressure and force data collected by the sensors, help to identify and evaluate biomechanical changes.
Video material will not be recorded or stored. Using the Zebris software, quantitative data on plantar pressure distribution and gait parameters are provided.
Measured: will take up to 5 minutes
Assessment of the range of motion
The range of motion of the spine and neck will be assessed using Baseline Bubble Inclinometer - 360° (NY, USA) inclinometers. The inclinometers will be used to measure the range of motion of the cervical spine, thoracic spine, and lumbar spine.
The range of motion of the shoulder and lower limb joints will be assessed using a goniometer.
Measured: will take up to 20 minutes
Muscle strength assessment
Muscle strength will be assessed using the Dr. Wolff BackCheck® 617 dynamometer (Dr. WOLFF Sports \& Prevention GmbH, Arnsberg, Germany). The maximal isometric strength of the trunk and neck extensors, flexors, and lateral flexors, as well as the muscles responsible for thigh movements, will be evaluated.
Muscle strength will be assessed while the participant stands in a neutral position. Pressure pads will be placed against the participant's body, against which the participant will be required to exert resistance.
To assess isometric handgrip strength, a hydraulic hand dynamometer (Saehan®, SH5001, South Korea) will be used. Handgrip isometric strength will be evaluated while the participant is standing and holding the dynamometer in the hand. The arm will be flexed at a 90° angle at the elbow joint. The participant will be asked to squeeze the dynamometer handle with maximal effort for 2 seconds.
Measured: will take up to 10 minutes
Body awareness assessment
To assess subjective body awareness, the Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire will be used. The questionnaire consists of 32 items divided into eight different domains: noticing, not distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, trusting.
For the assessment of objective body awareness, balance and movement control will be evaluated using the Biodex Balance System SD (version 4.x) (NY, USA) balance assessment system.
Measured: will take up to 18 minutes
Multidimensional fatigue inventory
The Multidimensional Fatigue Inventory (MFI) will be used to assess the level of fatigue experienced by the participants.
Measured: will take up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Joint HypermobilityStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 511 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernesta Aukštuolytė, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476976
- Sponsor's protocol ID
- BE-2-142
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant privacy and confidentiality.
Publications
Engelbert RH, Rombaut L. Clinimetrics: Assessment of generalised joint hypermobility: the Beighton score. J Physiother. 2022 Jul;68(3):208. doi: 10.1016/j.jphys.2022.02.004. Epub 2022 Mar 10. No abstract available.
PubMed 35283050Malfait F, Colman M, Vroman R, De Wandele I, Rombaut L, Miller RE, Malfait AM, Syx D. Pain in the Ehlers-Danlos syndromes: Mechanisms, models, and challenges. Am J Med Genet C Semin Med Genet. 2021 Dec;187(4):429-445. doi: 10.1002/ajmg.c.31950. Epub 2021 Nov 19.
PubMed 34797601Hirsch C, Hirsch M, John MT, Bock JJ. Reliability of the Beighton Hypermobility Index to determinate the general joint laxity performed by dentists. J Orofac Orthop. 2007 Sep;68(5):342-52. doi: 10.1007/s00056-007-0708-z.
PubMed 17882362Boyle KL, Witt P, Riegger-Krugh C. Intrarater and Interrater Reliability of the Beighton and Horan Joint Mobility Index. J Athl Train. 2003 Dec;38(4):281-285.
PubMed 14737208Evans AM, Rome K, Peet L. The foot posture index, ankle lunge test, Beighton scale and the lower limb assessment score in healthy children: a reliability study. J Foot Ankle Res. 2012 Jan 9;5(1):1. doi: 10.1186/1757-1146-5-1.
PubMed 22230105Bulbena A, Duro JC, Porta M, Faus S, Vallescar R, Martin-Santos R. Clinical assessment of hypermobility of joints: assembling criteria. J Rheumatol. 1992 Jan;19(1):115-22.
PubMed 1556672Smits-Engelsman B, Klerks M, Kirby A. Beighton score: a valid measure for generalized hypermobility in children. J Pediatr. 2011 Jan;158(1):119-23, 123.e1-4. doi: 10.1016/j.jpeds.2010.07.021. Epub 2010 Sep 17.
PubMed 20850761Juul-Kristensen B, Rogind H, Jensen DV, Remvig L. Inter-examiner reproducibility of tests and criteria for generalized joint hypermobility and benign joint hypermobility syndrome. Rheumatology (Oxford). 2007 Dec;46(12):1835-41. doi: 10.1093/rheumatology/kem290. Epub 2007 Nov 15.
PubMed 18006569Drevin J, Stern J, Annerback EM, Peterson M, Butler S, Tyden T, Berglund A, Larsson M, Kristiansson P. Adverse childhood experiences influence development of pain during pregnancy. Acta Obstet Gynecol Scand. 2015 Aug;94(8):840-6. doi: 10.1111/aogs.12674. Epub 2015 Jun 3.
PubMed 25965273Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med. 1996 Sep;3(9):895-900. doi: 10.1111/j.1553-2712.1996.tb03538.x.
PubMed 8870764Glans M, Humble MB, Elwin M, Bejerot S. Self-rated joint hypermobility: the five-part questionnaire evaluated in a Swedish non-clinical adult population. BMC Musculoskelet Disord. 2020 Mar 17;21(1):174. doi: 10.1186/s12891-020-3067-1.
PubMed 32183749Mapi. Linguistic Validation Guidance of a Clinical Outcome Assessment (COA). Linguistic Validation Guidance of a Clinical Outcome Assessment. 2016;33: 1-10.
Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
PubMed 15804318
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of the Functional State of the Musculoskeletal System, Body Awareness, and Quality of Life in Individuals With Joint Hypermobility, Their Associations, and Guidelines for Intervention.
- ClinicalTrials.gov ID
- NCT07476976
- Acronym / sponsor ID
- BE-2-142
- Conditions
- Joint Hypermobility
- Keywords
- joint hypermobility, hypermobility spectrum disorder
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 511 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 17 Mar 2026 (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.
The goal of this observational study is to learn about the characteristics of the functional state of the musculoskeletal system, body awareness, and quality of life in individuals with joint hypermobility, their associations, and guidelines for intervention.The main questions it aims to answer are:
- To evaluate the joint hypermobility in young women and the associated symptoms using translated, adapted, and validated Lithuanian versions of questionnaires;
- To evaluate and compare the functional characteristics of the musculoskeletal system in women with and without generalized joint hypermobility;
- To evaluate and compare the characteristics of the objective and subjective body awareness and quality of life of women with and without general joint hypermobility;
- To determine the characteristics and correlations of the functional state of the musculoskeletal system, body awareness and quality of life in subjects with general joint hypermobility;
- To develop guidelines for the management of individuals with generalized joint hypermobility within the scope of competence of a physical therapist.
The translation, cultural adaptation, and validity of the five-part Bristol Impact of Hypermobility Questionnaire will be performed. Factors that may influence the manifestation of symptomatic generalized joint hypermobility will be identified; The functional status of the musculoskeletal system, objective and subjective body awareness, characteristics, and their interrelationships will be assessed and compared in individuals with and without generalized joint hypermobility. Guidelines for intervention will be developed within the competence of a physical therapist for individuals with generalized joint hypermobility.
Detailed description
Criteria for inclusion in the biomedicine study.
First stage of the study (cultural adaptation of the five-part questionnaire and the Bristol Impact of Hypermobility Questionnaire): women and men aged 20 and over who voluntarily agreed to participate in the study.
Second stage of the study: women aged 20 to 40 who voluntarily agree to participate in the study. Depending on their Beighton score and Five-Part Questionnaire score, the subjects will be divided into a study group (women with joint hypermobility: 5 or more points on the Beighton scale; 2 or more points on the Five-Part Questionnaire) and a control group (women without joint hypermobility: less than 5 points on the Beighton scale; less than 2 points on the Five-Part Questionnaire).
Criteria for exclusion from biomedicine research:
Pregnancy and the first year after childbirth; Connective tissue diseases (e.g., Marfan syndrome, osteogenesis imperfecta); Demyelinating, inflammatory neurological diseases; Malignant tumors; Female athletes; Individuals who participate or have participated in physical activities that emphasize flexibility training; Other systemic diseases (e.g., rheumatoid arthritis, diabetes mellitus); Obesity (BMI >30 kg/m²); Menopause.
This study will be conducted in two stages. First, translation and adaptation of the Five-Part and Bristol Impact of Hypermobility Questionnaires for cross-cultural use. The next stage will be a prospective observational study to assess the functional status of the musculoskeletal system, body awareness and quality of life characteristics of people with generalized joint hypermobility, identify correlations and develop guidelines for intervention.
The translation and cultural adaptation of the Five Part Questionnaire and the Bristol Impact of Hypermobility Questionnaire will be carried out in accordance with the guidelines recommended by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Mapi Research Trust.
The second stage of the study is prospective and observational. During the study, the subjects will undergo anthropometric measurements of height and weight, questionnaire survey, assessment of body posture, foot pressure distribution, gait, balance, movement control, range of motion, muscle strength, interoceptive awareness, pain, fatigue, and quality of life.
The following will be conducted for the subjects:
Survey: several short surveys will be conducted. One of them will be accessible via a QR code and an active link, which will be added to the invitation to participate in the study. This short survey is designed to allow us to immediately select participants based on inclusion and exclusion criteria. Participants will complete this survey online and will be able to see if they are eligible for the study. The second survey will be conducted at the Department of Sports Medicine, and participants will complete it in paper form. This questionnaire will seek to identify the health characteristics of the subjects that are important for safe testing. The third questionnaire will be designed to identify certain lifestyle factors and characteristics of pain experienced that may be related to joint hypermobility. The questionnaire will take up to 5 minutes to complete.
Pain assessment. A digital analogy scale (DAS) will be used to assess the pain experienced by the subjects. Using the DAS, subjective pain experience will be assessed on a scale from 0 to 10, where 0 means "no pain" and the highest rating of 10 means "very severe pain." To determine the location of pain, the freely accessible human body map created by Drevin et al. in 2015 will be used, on which the researcher will mark the painful areas of the body indicated by the subject.
Height and weight measurement. The height and weight of the subjects will be assessed using Wunder C-201 medical scales. Before this measurement is taken, the subject will be asked to remove their shoes and outer clothing. The height and weight assessment will take up to 2 minutes.
Physical activity is assessed using the Baecke Physical Activity Questionnaire (original short version).
The Beighton scale will be used to assess generalized joint hypermobility: the subject will be asked to perform 9 movements, based on which will be assessed whether the subject has generalized joint hypermobility or not.
A five-part questionnaire will be used to confirm generalized joint hypermobility, during which the subject will be asked to answer five questions related to joint hypermobility in written form.
Body posture assessment: the Diers Formetric 4D system (Diers International GmbH, Schlangenbad, Germany) and APECS AL Posture Evaluation and Correction System mobile app will be used to assess body posture.
The Zebris system (Zebris Medical GmbH, Germany) will be used to assess foot pressure distribution and gait.
The range of motion of the spine and neck will be assessed using Baseline Bubble Inclinometer - 360° (NY, USA) inclinometers.
The assessment of neck and spine motion amplitudes using an inclinometer will be performed based on the methodology described in Cynthia C. Norkin and D. Joyce White (F.A. Davis) Measurement of Joint Motion: A Guide to Goniometry (2024).
The assessment of the range of motion of the shoulder and lower limb joints using a goniometer will be performed based on the methodology described in Cynthia C. Norkin and D. Joyce White (F.A. Davis) Measurement of Joint Motion: A Guide to Goniometry (2024).
The Dr. Wolff BackCheck® 617 dynamometer (Dr. WOLFF Sports \& Prevention GmbH, Arnsberg, Germany) will be used to assess muscle strength.
A hydraulic hand dynamometer (Saehan®, SH5001, South Korea) will be used to measure isometric hand strength.
A multidimensional awareness questionnaire (MAIA) will be used to assess subjective body awareness.
To assess objective body awareness, balance and movement control will be evaluated using the Biodex Balance System SD (version 4.x) (NY, USA) balance assessment system.
The SF-36 quality of life questionnaire will be used to assess quality of life. Multidimensional fatigue inventory will be used the Multidimensional Fatigue Inventory (MFI) to assess the fatigue experienced by the subjects.
The data will be analyzed using Microsoft Excel 2024 and IBM SPSS 30.0 software. Parametric and non-parametric tests will be applied to compare independent samples, while correlation analysis will be used to determine relationships between variables. For the analysis of causal relationships, multiple regression analysis will be conducted. Data analyzed using parametric tests will be described as mean ± 95% confidence interval, whereas data analyzed using non-parametric tests will be described using medians and interquartile ranges. Descriptive statistical methods, correlation analysis, questionnaire reliability, and factor analysis will be applied. The significance level will be set at α = 0.05.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generalized joint hypermobility group | – | Other: No interventionGeneralized joint hypermobility group |
| Control group | – | Other: No interventionWithout generalized joint hypermobility |
Who may qualify
- Ages
- 20 to 100 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- First stage of the study (cultural adaptation of the five-part questionnaire and the Bristol Impact of Hypermobility Questionnaire): women and men aged 20 and over who voluntarily agreed to participate in the study. Second stage of the study: women aged 20 to 40 who voluntarily agree to participate in the study. Depending on their Beighton score and Five-Part Questionnaire score, the subjects will be divided into a study group (women with joint hypermobility: 5 or more points on the Beighton scale; 2 or more points on the Five-Part Questionnaire) and a control group (women without joint hypermobility: less than 5 points on the Beighton scale; less than 2 points on the Five-Part Questionnaire).
Key inclusion criteria (2 listed)
- First stage of the study (cultural adaptation of the five-part questionnaire and the Bristol Impact of Hypermobility Questionnaire): women and men aged 20 and over who voluntarily agreed to participate in the study.
- Second stage of the study: women aged 20 to 40 who voluntarily agree to participate in the study. Depending on their Beighton score and Five-Part Questionnaire score, the subjects will be divided into a study group (women with joint hypermobility: 5 or more points on the Beighton scale; 2 or more points on the Five-Part Questionnaire) and a control group (women without joint hypermobility: less than 5 points on the Beighton scale; less than 2 points on the Five-Part Questionnaire).
Key exclusion criteria (1 listed)
- Pregnancy and the first year after childbirth; Connective tissue diseases (e.g., Marfan syndrome, osteogenesis imperfecta); Demyelinating, inflammatory neurological diseases; Malignant tumors; Female athletes; Individuals who participate or have participated in physical activities that emphasize flexibility training; Other systemic diseases (e.g., rheumatoid arthritis, diabetes mellitus); Obesity (BMI >30 kg/m²); Menopause.
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 |
|---|---|---|
| No interventionNo intervention | Other | Control group, Generalized joint hypermobility group |
Primary outcome
Questionnaire survey
Time frame: The survey will take up to 5 minutes to complete.
Several short surveys will be conducted. One of them will be accessible via a QR code and an active link, which will be added to the invitation to participate in the study. This short survey is designed to help us immediately select participants based on inclusion and exclusion criteria. Participants will complete this survey online and will be able to see whether they are eligible for the study. The second survey will be conducted at the Department of Sports Medicine, and participants will complete it in paper form. This questionnaire will seek to identify the health characteristics of the subjects that are important for safe testing. The third questionnaire will be designed to identify certain lifestyle factors and characteristics of pain experienced that may be related to joint hypermobility.
Five part questionnaire
Time frame: Takes up to 2 minutes
Beighton score
Time frame: Takes up to 5 minutes
Baecke Physical Activity questionnaire
Time frame: Takes up to 5 minutes
Bristol Impact of Hypermobility questionnaire
Time frame: Takes up to 10 minutes
SF-36 questionnaire
Time frame: Takes up to 5 minutes
This questionnaire will be used in the cultural adaptation process of the Bristol Impact of Hypermobility questionnaire.
9 secondary outcomes
Numerical Rating Scale
Time frame: will take up to 2 minutes
Body map
Time frame: will take up to 2 minutes
Height and weight measurement
Time frame: Height and weight assessment takes up to 2 minutes.
Body posture assessment
Time frame: will take up to 10 minutes
Foot pressure distribution and gait
Time frame: will take up to 5 minutes
Assessment of the range of motion
Time frame: will take up to 20 minutes
Muscle strength assessment
Time frame: will take up to 10 minutes
Body awareness assessment
Time frame: will take up to 18 minutes
Multidimensional fatigue inventory
Time frame: will take up to 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 35283050Engelbert RH, Rombaut L. Clinimetrics: Assessment of generalised joint hypermobility: the Beighton score. J Physiother. 2022 Jul;68(3):208. doi: 10.1016/j.jphys.2022.02.004. Epub 2022 Mar 10. No abstract available.
- Background: PubMed 34797601Malfait F, Colman M, Vroman R, De Wandele I, Rombaut L, Miller RE, Malfait AM, Syx D. Pain in the Ehlers-Danlos syndromes: Mechanisms, models, and challenges. Am J Med Genet C Semin Med Genet. 2021 Dec;187(4):429-445. doi: 10.1002/ajmg.c.31950. Epub 2021 Nov 19.
- Background: PubMed 17882362Hirsch C, Hirsch M, John MT, Bock JJ. Reliability of the Beighton Hypermobility Index to determinate the general joint laxity performed by dentists. J Orofac Orthop. 2007 Sep;68(5):342-52. doi: 10.1007/s00056-007-0708-z.
- Background: PubMed 14737208Boyle KL, Witt P, Riegger-Krugh C. Intrarater and Interrater Reliability of the Beighton and Horan Joint Mobility Index. J Athl Train. 2003 Dec;38(4):281-285.
- Background: PubMed 22230105Evans AM, Rome K, Peet L. The foot posture index, ankle lunge test, Beighton scale and the lower limb assessment score in healthy children: a reliability study. J Foot Ankle Res. 2012 Jan 9;5(1):1. doi: 10.1186/1757-1146-5-1.
- Background: PubMed 1556672Bulbena A, Duro JC, Porta M, Faus S, Vallescar R, Martin-Santos R. Clinical assessment of hypermobility of joints: assembling criteria. J Rheumatol. 1992 Jan;19(1):115-22.
- Background: PubMed 20850761Smits-Engelsman B, Klerks M, Kirby A. Beighton score: a valid measure for generalized hypermobility in children. J Pediatr. 2011 Jan;158(1):119-23, 123.e1-4. doi: 10.1016/j.jpeds.2010.07.021. Epub 2010 Sep 17.
- Background: PubMed 18006569Juul-Kristensen B, Rogind H, Jensen DV, Remvig L. Inter-examiner reproducibility of tests and criteria for generalized joint hypermobility and benign joint hypermobility syndrome. Rheumatology (Oxford). 2007 Dec;46(12):1835-41. doi: 10.1093/rheumatology/kem290. Epub 2007 Nov 15.
- Background: PubMed 25965273Drevin J, Stern J, Annerback EM, Peterson M, Butler S, Tyden T, Berglund A, Larsson M, Kristiansson P. Adverse childhood experiences influence development of pain during pregnancy. Acta Obstet Gynecol Scand. 2015 Aug;94(8):840-6. doi: 10.1111/aogs.12674. Epub 2015 Jun 3.
- Background: PubMed 8870764Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med. 1996 Sep;3(9):895-900. doi: 10.1111/j.1553-2712.1996.tb03538.x.
- Background: PubMed 32183749Glans M, Humble MB, Elwin M, Bejerot S. Self-rated joint hypermobility: the five-part questionnaire evaluated in a Swedish non-clinical adult population. BMC Musculoskelet Disord. 2020 Mar 17;21(1):174. doi: 10.1186/s12891-020-3067-1.
- BackgroundMapi. Linguistic Validation Guidance of a Clinical Outcome Assessment (COA). Linguistic Validation Guidance of a Clinical Outcome Assessment. 2016;33: 1-10.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect participant privacy and confidentiality.
Related trials for Joint Hypermobility
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty
Enrolling by invitationObservational study
Presentation of Young Adults With and Without Joint Hypermobility
Hypermobile Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS)
RecruitingObservational study
A Study on Associations Between Multidimensional Human Phenotypic Traits and Human Growth and Development
Musculoskeletal Growth and Development
Not yet recruitingPhase 1/2
Regenerative Medicine for Joint Hypermobility and Instability
Ehlers-Danlos Syndrome Hypermobility Type (hEDS), Ehlers-Danlos Syndrome (EDS)
Active, not recruiting
Whole-Body Vibration and Postural Stability in Painful HSD
Hypermobility Spectrum Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Joint Hypermobility, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 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: enrolling by invitation, as of the sponsor's last update on 17 Mar 2026. 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 Lithuania. 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?
This study is still under way. Results are not available in the source record yet.
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?
Questionnaire survey (time frame: The survey will take up to 5 minutes to complete.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07476976, which also lists 13 linked publications.
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 17 Mar 2026.