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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Generalized joint hypermobility group | Generalized joint hypermobility group |
| |
| Control group | Without generalized joint hypermobility |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The survey will take up to 5 minutes to complete. |
| Five part questionnaire | Takes up to 2 minutes | |
| Beighton score | Takes up to 5 minutes | |
| Baecke Physical Activity questionnaire | Takes up to 5 minutes | |
| Bristol Impact of Hypermobility questionnaire | 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. | Takes up to 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale | will take up to 2 minutes | |
| Body map | Body map by Drevin et al. for the location of pain | will take up to 2 minutes |
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Inclusion Criteria:
Exclusion Criteria (in the second stage of the study):
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LSMU Department of Sports Medicine | Kaunas | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35283050 | Background | 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. | |
| 34797601 | Background | Malfait 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. |
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Individual participant data will not be shared in order to protect participant privacy and confidentiality.
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | will take up to 5 minutes |
| 17882362 | Background | Hirsch 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. |
| 14737208 | Background | Boyle 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. |
| 22230105 | Background | Evans 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. |
| 1556672 | Background | Bulbena 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. |
| 20850761 | Background | Smits-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. |
| 18006569 | Background | Juul-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. |
| 25965273 | Background | Drevin 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. |
| 8870764 | Background | Buderer 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. |
| 32183749 | Background | Glans 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. |
| Background | Mapi. Linguistic Validation Guidance of a Clinical Outcome Assessment (COA). Linguistic Validation Guidance of a Clinical Outcome Assessment. 2016;33: 1-10. |
| 15804318 | Background | 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. |
| ID | Term |
|---|---|
| D007593 | Joint Instability |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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