NCT05558202

Brief Summary

Hypermobility is more than normal joint laxity, mobility, and range of motion. It is characterized by increased laxity and fragility of connective tissues. Symptoms from hypermobility can begin at any age and affect women more than men. People are at higher risk than other people. It is stated that hypermobility is an important factor in orthopedic injuries and diseases. Individuals with hypermobility have more frequent orthopedic complaints and the problems are usually idiopathic and chronic. Studies have reported that proprioception and musculoskeletal reflex function may be affected independently of symptoms in hypermobile individuals. Therefore, evaluating hypermobility is very important in preventing hypermobility-related problems and injuries and developing appropriate treatment methods. Although the Beighton score is the most commonly used scoring method to determine hypermobility, it may be insufficient to determine hypermobility of the lower extremities. The Lower Limb Assessment Score (LLAS) has been reported to be one of the most appropriate scoring methods for assessing lower extremity hypermobility in the literature. The aim of this study is to adapt LLAS to Turkish and measure its validity and reliability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 2, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

September 23, 2022

Last Update Submit

August 1, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Lower Limb Assessment Score (LLAS)

    The LLAS was designed to test the mobility of many joints of the lower limb in multiple planes of motion. These tests include passive physiological, passive accessory and active range of motion. The LLAS is performed on both lower limbs, each providing a score to a maximum of 12.

    10 minutes

  • The Beighton Score

    The Beighton Score is a set of manoeuvres used as the standard method of assessment for Generalised Joint Hypermobility. The Beighton score arbitrarily investigates the presence of hyperlaxity (yes = 1, no = 0) at both wrists, the fifth metacarpo-phalangeal joints, elbows, knee joints, and the lumbosacral spine. The items are summed and yield a Beighton score ranging from 0 to 9 points.

    5 minutes

Interventions

1. Explanation of the Turkish version of the scale. 2. Translating the Turkish version of the scale into English to ensure consistency with the original scale. 3. First application of scales to participants by two examiners separately. 4. Second application of the scales to the participants by one examiner. 5. Statistical analysis and scaling

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

\- The study will be carried out by young adults and adults in the Kutahya Health Science University

You may qualify if:

  • Healthy volunteers
  • Aged between 18 to 35

You may not qualify if:

  • Using assistive devices or orthoses for the upper extremity
  • Surgery history of the upper extremity
  • Pain located on the upper extremity in the last 6 months
  • Previous trauma that might restrict normal range of motion.
  • Having degenerative or inflamatuar disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Science University

Kütahya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Emrah Afsar, Phd

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Occupational Therapy Deparment

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 28, 2022

Study Start

September 30, 2022

Primary Completion

October 30, 2022

Study Completion

December 30, 2022

Last Updated

August 2, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations