Child, OnlyNCT06350240
Effects of Textured Insoles and Exercise in Children With Joint Hypermobility
A study testing Exercise and Exercise+texture insoles in people with Child, Only and Joint Laxity, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Joint hypermobility is the condition that the joints have a greater range of motion than normal and can be observed frequently in children. In children with joint hypermobility, motor problems, tactile and proprioceptive sensory disorders can be observed. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Joint Laxity, Exercise
- What is being tested?
- Exercise and Exercise+texture insoles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 30 Nov 2024
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children with a Beighton score of 6 and above
- Being between the ages of 5-18
- Being cooperative in the assessments and treatment
- Having a body mass index between 18.5-24.9
Who cannot join
- Having had any surgery or trauma in the last 6 months
- Having any neurological, metabolic, rheumatological or chronic disease.
- Having a vestibular system problem
- Being diagnosed with Ehlers-Danlos Syndrome
- Having foot wounds and anomalies that may affect sole sensation
- Having chronic pain.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara
Kamile Uzun Akkaya, Phd
About this study
Official title: Investigation of the Effects of Textured Insoles and Exercise on Tactile Sense, Balance, Foot Load Distribution and Quality of Life in Children With Joint Hypermobility
Joint hypermobility is the condition that the joints have a greater range of motion than normal and can be observed frequently in children. In children with joint hypermobility, motor problems, tactile and proprioceptive sensory disorders can be observed. It is very important to support children with joint hypermobility with intervention programs that are rich in both motor and sensory aspects. The aim of this project is to create an exercise protocol rich in tactile, proprioceptive senses for children with joint hypermobility and to examine the effects of using textured insoles in addition to exercise on tactile sense, balance, foot load distribution and quality of life in children.
Read the detailed description
It was planned to include 40 children with joint hypermobility in the project. Children's joint hypermobility will be determined by the Beighton Score. Children will be divided into two groups. Children in both groups will be offered an exercise program consisting of home and park activities that will improve their motor and sensory aspects. Children in the intervention group will be asked to additionally use textured insoles. Before and after the study, children's plantar foot tactile sense, balance, foot load distribution and quality of life will be evaluated. Pre- and post-treatment values and change values in both groups will be compared with each other.
- Conditions
- Child, Only, Joint Laxity, Exercise, Textured Insoles
- Being tested
- Exercise, Exercise+texture insoles
- Medical subject headings
- Joint Instability, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
An exercise program that can be easily applied at home and in the park, which will support the psychomotor, tactile and proprioceptive-rich sensory development specific to children with joint hypermobility. The family will be instructed to do these exercises for 30 minutes a day for 5 days in total, 2 days a week in the playground and 3 days at home for 6 weeks, and the family will be asked to keep a diary to see whether they do the exercises or not.
Exercise+texture insolesBehavioural
In addition to exercise, children in this group will have an individual textured insoles made to suit the child's foot. The child will be asked to place textured insoles inside his shoes and use the textured insoles for 6-8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Exercise group Receives: Behavioral: Exercise |
| Intervention group | Experimental | Exercise and use of textured insoles group Receives: Behavioral: Exercise+texture insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tactile sense
Tactile sensory evaluation was performed with Semmes-Weinstein Monofilaments.
Measured: Through study completion, an average of 1 year
Foot load distribution
Diagnostic Support Baropodometer Footscan® 3D system will be used for static and dynamic pedobarographic analysis.
Measured: Through study completion, an average of 1 year
Balance
Biodex Balance System will be used for static balance assessment. Functional reach test will be used for dynamic balance assessment. The child will be asked to stand sideways against the wall. Marking will be made from the tip of the third finger, with the child's arm flexed at 90 degrees. The child will be asked to reach forward as far as he can without taking a step, lifting his heels off the ground, and without changing his arm position. The third fingertip will be marked again and the distance between the two marks will be measured in centimeters
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Foot posture
Foot posture analysis will be evaluated using the Foot Posture Index.
Measured: Through study completion, an average of 1 year
Quality of life assessment
Children's quality of life will be evaluated with the 'Pediatric Quality of Life Inventory'.This scale is a quality of life scale that evaluates children's physical and psychosocial experiences. Turkish validity and reliability studies have been conducted.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Nov 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Kamile Uzun Akkaya, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350240
- Sponsor's protocol ID
- KUzunAkkaya
- Status last verified
- Apr 2024
- First submitted
- 1 Apr 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Textured Insoles and Exercise on Tactile Sense, Balance, Foot Load Distribution and Quality of Life in Children With Joint Hypermobility
- ClinicalTrials.gov ID
- NCT06350240
- Acronym / sponsor ID
- KUzunAkkaya
- Conditions
- Child, Only, Joint Laxity, Exercise, Textured Insoles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 5 Apr 2024 (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.
Joint hypermobility is the condition that the joints have a greater range of motion than normal and can be observed frequently in children. In children with joint hypermobility, motor problems, tactile and proprioceptive sensory disorders can be observed. It is very important to support children with joint hypermobility with intervention programs that are rich in both motor and sensory aspects. The aim of this project is to create an exercise protocol rich in tactile, proprioceptive senses for children with joint hypermobility and to examine the effects of using textured insoles in addition to exercise on tactile sense, balance, foot load distribution and quality of life in children.
Detailed description
It was planned to include 40 children with joint hypermobility in the project. Children's joint hypermobility will be determined by the Beighton Score. Children will be divided into two groups. Children in both groups will be offered an exercise program consisting of home and park activities that will improve their motor and sensory aspects. Children in the intervention group will be asked to additionally use textured insoles. Before and after the study, children's plantar foot tactile sense, balance, foot load distribution and quality of life will be evaluated. Pre- and post-treatment values and change values in both groups will be compared with each other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Behavioral: ExerciseExercise group |
| Intervention group | Experimental | Behavioral: Exercise+texture insolesExercise and use of textured insoles group |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children with a Beighton score of 6 and above
- Being between the ages of 5-18
- Being cooperative in the assessments and treatment
- Having a body mass index between 18.5-24.9
Key exclusion criteria (6 listed)
- Having had any surgery or trauma in the last 6 months
- Having any neurological, metabolic, rheumatological or chronic disease.
- Having a vestibular system problem
- Being diagnosed with Ehlers-Danlos Syndrome
- Having foot wounds and anomalies that may affect sole sensation
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 |
|---|---|---|
| ExerciseAn exercise program that can be easily applied at home and in the park, which will support the psychomotor, tactile and proprioceptive-rich sensory development specific to children with joint hypermobility. The family will be instructed to do these exercises for 30 minutes a day for 5 days in total, 2 days a week in the playground and 3 days at home for 6 weeks, and the family will be asked to keep a diary to see whether they do the exercises or not. | Behavioural | Control group |
| Exercise+texture insolesIn addition to exercise, children in this group will have an individual textured insoles made to suit the child's foot. The child will be asked to place textured insoles inside his shoes and use the textured insoles for 6-8 hours. | Behavioural | Intervention group |
Primary outcome
Tactile sense
Time frame: Through study completion, an average of 1 year
Tactile sensory evaluation was performed with Semmes-Weinstein Monofilaments.
Foot load distribution
Time frame: Through study completion, an average of 1 year
Diagnostic Support Baropodometer Footscan® 3D system will be used for static and dynamic pedobarographic analysis.
Balance
Time frame: Through study completion, an average of 1 year
Biodex Balance System will be used for static balance assessment. Functional reach test will be used for dynamic balance assessment. The child will be asked to stand sideways against the wall. Marking will be made from the tip of the third finger, with the child's arm flexed at 90 degrees. The child will be asked to reach forward as far as he can without taking a step, lifting his heels off the ground, and without changing his arm position. The third fingertip will be marked again and the distance between the two marks will be measured in centimeters
2 secondary outcomes
Foot posture
Time frame: Through study completion, an average of 1 year
Quality of life assessment
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Exercise+texture insoles in people with Child, Only and Joint Laxity, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamile Uzun Akkaya, PhD (03122162683, kamileuzunakkaya@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tactile sense (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 5 Apr 2024.