Effects of Textured Insoles and Exercise in Children With Joint Hypermobility

NCT06350240 | Recruiting

• 1 other identifier: KUzunAkkaya
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Child, Only; Joint Laxity; Exercise; Textured Insoles

Outcome Measures

Primary Outcomes (3)

• Tactile sense

  Tactile sensory evaluation was performed with Semmes-Weinstein Monofilaments.

  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.

  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

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Foot posture

  Through study completion, an average of 1 year

• Quality of life assessment

  Through study completion, an average of 1 year

Study Arms (2)

Control group

EXPERIMENTAL

Exercise group

Behavioral: Exercise

Intervention group

EXPERIMENTAL

Exercise and use of textured insoles group

Behavioral: Exercise+texture insoles

Interventions

Exercise 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.

Control group

Exercise+texture insoles 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.

Intervention group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Joint Instability; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Kamile Uzun Akkaya, PhD

CONTACT

03122162683; kamileuzunakkaya@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 30, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

TU (1)