Child DevelopmentNCT06041191
Sensory Processing Skills in Toddler With Joint Hypermobility
An observational study of Child Development and Sensory Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
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]. Read more about this study
- Who is it for?
- Ages 12 to 14 months
- Conditions the study is for
- Child Development, Sensory Disorder, Hypermobility, Joint
- What is being tested?
- Assessment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 months
- All sexes
- Child
Study population: Healthy children born at term between 12-14 months
Who may be able to join
- 12-14 month old healthy children
- -
Who cannot join
- they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Child Development, Sensory Disorder, Hypermobility, Joint
- Being tested
- Assessment
- Medical subject headings
- Sensation Disorders, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20minutes
Secondary outcomes (1)
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Jun 2023
- Primary completion15 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Simsek, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041191
- Sponsor's protocol ID
- E-77082166-604.01.02-687785
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Sensory Processing Skills in Toddler With Joint Hypermobility
- ClinicalTrials.gov ID
- NCT06041191
- Acronym / sponsor ID
- E-77082166-604.01.02-687785
- Conditions
- Child Development, Sensory Disorder, Hypermobility, Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with GJH | – | Diagnostic Test: AssessmentChildren 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 |
| Children without GJH | – | Diagnostic Test: AssessmentChildren 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 |
Who may qualify
- Ages
- 12 to 14 months
- Sex
- All
- Age groups
- Child
- Study population
- Healthy children born at term between 12-14 months
Key inclusion criteria (2 listed)
- 12-14 month old healthy children
- -
Key exclusion criteria (1 listed)
- they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentThe 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. | Diagnostic test | Children with GJH, Children without GJH |
Primary outcome
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
1 secondary outcome
Test of Sensory Functions in Infants
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development and Sensory Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beighton Score (time frame: 20minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023; AzTrials last refreshed its copy on 31 Oct 2026.