NCT07476976

Brief 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. 1.To evaluate the joint hypermobility in young women and the associated symptoms using translated, adapted, and validated Lithuanian versions of questionnaires;
  2. 2.To evaluate and compare the functional characteristics of the musculoskeletal system in women with and without generalized joint hypermobility;
  3. 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. 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. 5.To develop guidelines for the management of individuals with generalized joint hypermobility within the scope of competence of a physical therapist.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
511

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Feb 2026Feb 2029

Study Start

First participant enrolled

February 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 9, 2026

Last Update Submit

March 12, 2026

Conditions

Keywords

joint hypermobilityhypermobility spectrum disorder

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (9)

  • Numerical Rating Scale

    will take up to 2 minutes

  • Body map

    will take up to 2 minutes

  • Height and weight measurement

    Height and weight assessment takes up to 2 minutes.

  • Body posture assessment

    will take up to 10 minutes

  • Foot pressure distribution and gait

    will take up to 5 minutes

  • +4 more secondary outcomes

Study Arms (2)

Generalized joint hypermobility group

Generalized joint hypermobility group

Other: No intervention

Control group

Without generalized joint hypermobility

Other: No intervention

Interventions

No intervention

Control groupGeneralized joint hypermobility group

Eligibility Criteria

Age20 Months - 100 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSMU Department of Sports Medicine

Kaunas, Lithuania

Location

Related Publications (13)

  • 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

    BACKGROUND
  • 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

    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; 68: 342-52.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    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; 19: 115-22.

    BACKGROUND
  • Smits-Engelsman B, Klerks M, Kirby A: Beighton score: a valid measure for generalized hypermobility in children. J Pediatr 2011; 158: 119-23

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    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;21(1):174. Published 2020 Mar 17. doi:10.1186/s12891-020-3067-

    BACKGROUND
  • Mapi. Linguistic Validation Guidance of a Clinical Outcome Assessment (COA). Linguistic Validation Guidance of a Clinical Outcome Assessment. 2016;33: 1-10.

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Sports Medicine

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 17, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared in order to protect participant privacy and confidentiality.

Locations