Clinical trial NCT06350240: Effects of Textured Insoles and Exercise in Children With Joint Hypermobility
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child, Only
Joint Laxity
Exercise
Textured Insoles
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Tactile sense
timeFrame: Through study completion, an average of 1 year
measure: Foot load distribution
timeFrame: Through study completion, an average of 1 year
measure: Balance
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Foot posture
timeFrame: Through study completion, an average of 1 year
measure: Quality of life assessment
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References: