Effects of Textured Insoles and Exercise in Children With Joint Hypermobility

NCT ID: NCT06350240

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-11-30

Brief Summary

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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

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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

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Textured Insoles Child, Only Joint Laxity Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control group

Exercise group

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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.

Intervention group

Exercise and use of textured insoles group

Group Type EXPERIMENTAL

Exercise+texture insoles

Intervention Type BEHAVIORAL

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.

Interventions

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Exercise

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.

Intervention Type BEHAVIORAL

Exercise+texture insoles

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Kamile Uzun Akkaya

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Kamile Uzun Akkaya, PhD

Role: CONTACT

03122162683

Facility Contacts

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Kamile Uzun Akkaya, Phd

Role: primary

Other Identifiers

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KUzunAkkaya

Identifier Type: -

Identifier Source: org_study_id

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