- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06041191
Sensory Processing Skills in Toddler With Joint Hypermobility
September 11, 2023 updated by: Ayse Simsek, Gazi University
An Investigation of Sensory Processing Skills in Toddler With Joint Hypermobility
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Erzurum, Turkey
- Erzurum Technical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Healthy children born at term between 12-14 months
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beighton Score
Time Frame: 20minutes
|
. 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test of Sensory Functions in Infants
Time Frame: 20 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Actual)
July 15, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
September 11, 2023
First Submitted That Met QC Criteria
September 11, 2023
First Posted (Actual)
September 18, 2023
Study Record Updates
Last Update Posted (Actual)
September 18, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77082166-604.01.02-687785
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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