NCT06041191

Brief Summary

shows that children and adults with joint hypermobility may be identified with common clinical problems that are unrelated, such as chronic fatigue, anxiety, and a range of gastrointestinal functional disorders \[4-6\]. Considering the relationship of joint hypermobility with joint muscle tone and posture, sensory processing skills may also be affected in individuals with hypermobility. No study in the literature examines the relationship between joint hypermobility and sensory processing. This study was planned to detect joint hypermobility as early as 12-14 months and to examine its relationship with sensory processing skills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

September 11, 2023

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Beighton Score

    . The test consists of 5 items: (1) positive if the passive dorsiflexion of the fifth metacarpophalangeal joint score is greater than 90 degrees (bilateral test); (2) positive if passive hyperextension of the elbow joint is \>10 (bilateral test); (3) positive if passive hyperextension of the knee joint is \>10 (bilateral test); (4) passive apposition of the thumb to the flexor side of the forearm is positive for joint hypermobility (bilateral test) if the shoulder is at 90 flexion, the elbow is extended, and the whole thumb is touching the flexor side of the forearm; and (5) the score is positive when dorsiflexion of the ankle is \>30 (bilateral test). The assessment was performed on both the right and left sides, and the item was given 1 point if hypermobility was detected in the joints, and 0 points if not, according to the instructions of each item. Cut-off score of \>4 was used to define hypermobility

    20minutes

Secondary Outcomes (1)

  • Test of Sensory Functions in Infants

    20 minutes

Study Arms (2)

Children with GJH

Children who scored above 4 points in the hypermobility assessment made with the Beighton score were included in this group. sensory processing skills assessed with the Test of Sensory Functions in Infants

Diagnostic Test: Assessment

Children without GJH

Children who scored below 4 points in the hypermobility assessment made with the Beighton score were included in this group. sensory processing skills assessed with the Test of Sensory Functions in Infants

Diagnostic Test: Assessment

Interventions

AssessmentDIAGNOSTIC_TEST

The children included in the study were evaluated in terms of hypermobility and then divided into two groups. Children in both groups were evaluated in terms of sensory processing skills.

Children with GJHChildren without GJH

Eligibility Criteria

Age12 Months - 14 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy children born at term between 12-14 months

You may qualify if:

  • month old healthy children

You may not qualify if:

  • they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Technical University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sensation DisordersJoint Instability

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 18, 2023

Study Start

June 1, 2023

Primary Completion

July 15, 2023

Study Completion

September 1, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations