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临床试验/NCT07476976
NCT07476976Enrolling By Invitation不适用

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.

Lithuanian University of Health Sciences1 个研究点 分布在 1 个国家目标入组 511 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
511
试验地点
1
主要终点
Five part questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
20 Months 至 100 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • (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.

研究组 & 干预措施

Control group

Without generalized joint hypermobility

干预措施: No intervention (Other)

Generalized joint hypermobility group

Generalized joint hypermobility group

干预措施: No intervention (Other)

结局指标

主要结局

Five part questionnaire

时间窗: Takes up to 2 minutes

Beighton score

时间窗: Takes up to 5 minutes

Baecke Physical Activity questionnaire

时间窗: Takes up to 5 minutes

Bristol Impact of Hypermobility questionnaire

时间窗: Takes up to 10 minutes

Questionnaire survey

时间窗: 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.

SF-36 questionnaire

时间窗: Takes up to 5 minutes

This questionnaire will be used in the cultural adaptation process of the Bristol Impact of Hypermobility questionnaire.

次要结局

  • Body map(will take up to 2 minutes)
  • Numerical Rating Scale(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)
  • Assessment of the range of motion(will take up to 20 minutes)
  • Muscle strength assessment(will take up to 10 minutes)
  • Body awareness assessment(will take up to 18 minutes)
  • Multidimensional fatigue inventory(will take up to 5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ernesta Aukštuolytė

Department of Sports Medicine

Lithuanian University of Health Sciences

研究点 (1)

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