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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06041191
Other study ID # E-77082166-604.01.02-687785
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date September 1, 2023

Study information

Verified date September 2023
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date September 1, 2023
Est. primary completion date July 15, 2023
Accepts healthy volunteers
Gender All
Age group 12 Months to 14 Months
Eligibility Inclusion Criteria: 12-14 month old healthy children - Exclusion Criteria: - they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.

Study Design


Intervention

Diagnostic Test:
Assessment
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.

Locations

Country Name City State
Turkey Erzurum Technical University Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Test of Sensory Functions in Infants The TSFI is primarily used to assess sensory defense behaviors in infants aged 4-18 months. Test; It consists of 5 subsections and 24 items. TSFI requires the infant to be stimulated and interact with a variety of materials. The total score varies between 0-49 and the test has norm values for different age groups. Although it is used from the fourth month, the most reliable and valid results are obtained between 7-18 months. 20 minutes
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