An interventional study of Exercise and Exercise+texture insoles in Child, Only, Joint Laxity and Exercise, sponsored by Gazi University. Recruiting at 1 site in Turkey. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Gazi University · Not applicable, Interventional, and Treatment
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.
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.
115 studies on the registry are indexed under Joint Instability; 21 are open to participants now.
This study's planned enrollment of 40 is below the median of 46 across 58 interventional studies indexed under Joint Instability.
Browse Joint Instability studies →Gazi University is the lead sponsor of 551 studies on the registry; 102 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Exercise group
Behavioral: Exercise
Exercise and use of textured insoles group
Behavioral: Exercise+texture insoles
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.
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.
Tactile sense
Tactile sensory evaluation was performed with Semmes-Weinstein Monofilaments.
Time frame: 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.
Time frame: 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
Time frame: Through study completion, an average of 1 year
Foot posture
Foot posture analysis will be evaluated using the Foot Posture Index.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Nov 2024, 12 months after the start.
Of 36 non-industry interventional studies with no phase under Joint Instability, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's planned 12 months is below that.
Counting every sponsor, half of 41 studies reached it within 15 months; a quarter within 7 and three quarters within 60.
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