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 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. To evaluate the joint hypermobility in young women and the associated symptoms using translated, adapted, and validated Lithuanian versions of questionnaires;
2. To evaluate and compare the functional characteristics of the musculoskeletal system in women with and without generalized joint hypermobility;
3. 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;
4. 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;
5. 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Joint Hypermobility
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Estimated): 511

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania
    • LSMU Department of Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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).

Description

Inclusion Criteria:

• 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).

Exclusion Criteria (in the second stage of the study):

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Generalized joint hypermobility group	Other: No intervention; No intervention
Control group; Without generalized joint hypermobility	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences

Publications and helpful links

General Publications

• Engelbert RH, Rombaut L. Clinimetrics: Assessment of generalised joint hypermobility: the Beighton score. J Physiother. 2022;68(3):208. http://doi.org/10.1016/j.jphys.2022.02.004
• Malfait F, Colman M, Vroman R, De Wandele I, Rombaut L, Miller RE, et al. Pain in the Ehlers-Danlos syndromes: Mechanisms, models, and challenges. Am J Med Genet C Semin Med Genet. 2021;187(4):429-45. http://doi.org/10.1002/ajmg.c.31950
• 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; 68: 342-52.
• Boyle KL, Witt P, Riegger-Krugh C: Intrarater and Interrater Reliability of the Beighton and Horan Joint Mobility Index. J Athl Train 2003; 38: 281-5.
• Evans AM, Rome K, Peet L: The foot posture index, ankle lunge test, Beighton scale and the lower assessment score in healthy children: a reliability study. J Foot Ankle Res 2012; 5: 1-5.
• Bulbena A, Duro JC, Porta M, Faus S, Vallescar R, Martin-Santos R: Clinical assessment of hypermobility of joints: assembling criteria. J Rheumatol 1992; 19: 115-22.
• Smits-Engelsman B, Klerks M, Kirby A: Beighton score: a valid measure for generalized hypermobility in children. J Pediatr 2011; 158: 119-23
• Jull-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; 46: 1835-41.
• Drevin J, Stern J, Annerbäck EM, Peterson M, Butler S, Tydén 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. PMID: 25965273; PMCID: PMC5032994.
• Buderer NMF. Statistical methodology: I. incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med. 1996;3:895-900.
• 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;21(1):174. Published 2020 Mar 17. doi:10.1186/s12891-020-3067-
• Mapi. 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, et al. 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 in Health. 2005;8: 94-104. doi: 10.1111/j.1524-4733.2005.04054.x

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: joint hypermobility; hypermobility spectrum disorder
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Joint Instability
• Other Study ID Numbers: BE-2-142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared in order to protect participant privacy and confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No