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Completed

NCT Number: NCT06510933

Stability Effects After Heel Cups Orthopedics Treatment in Different BMI

Actual research relates Body mass Index (BMI) with postural changes in children and musculoskeletal disorders during growing period. BMI is widely used by clinicians and researchers due to easily capacity of application and scale classification patients in relation to their weight, the scale presents underweight, normal weight, overweight and obesity stages.

In paediatric context, underweight or overweight body mass in children negatively influences their posture, even in his adult life. Children with overweight and obesity shows less stability, and develop worse postural control, one of the demonstrated effects are the column alignment alteration and other bones structures. Elevated BMI are related to high differences in postural control, to elevated risk of pain, hypertension and musculoskeletal disorders. Underweight BMI is associated to less muscular mass and fat body composition, that are necessary to a correct posture, and contributes to increase probability of injuries.

The maintaining balance engages three systems, i.e., the vestibular system, vision, and proprioception. Some authors consider that postural stability develops between the ages 8 to 9. There are also papers arguing that the locomotor and postural model in 7-year-olds is similar to adults. Nevertheless, with new experiences and skills, it is possible to continue the development of all elements engaged in postural control, and keeping correct posture in children up to the age of 12 A good balance level and postural control is important in sport practice, to get high competition level efficiency in daily activities, and of course, in the clinic practice and rehabilitation.

Because of a stability loss off overweight in children, limited physical activity is established Posterior calf musculature and ankle has been shown to be involved in postural control in different studies. Likewise, the practice of physical activity induces changes in the infantile triceps suralis that generates improvements in postural control.

Currently, there are different paediatric pathologies for which heel cushions are prescribed as a treatment, such as Sever's disease leg, length discrepancy, relaxing and lenghtened calf muscles, but there is no evidence of stability effect of this treatment.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colegio Publico Cervantes

Munera, Albacete, 02612, Spain

About this study

A prospective intervention study was conducted in children before and after the application of heel cushions as a treatment for calf muscle retraction in various BMI conditions in children.

The design and progression of participants through the trial was conducted in accordance with the 22 CONSORT criteria.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children 8-12 years old
  • Regular sports practice
  • Decreased range of flexión

Exclusion criteria

  • Having neurological, vestibular, muscular, psychological or visual visual disease.
  • Traumatic pathology 12 months prior to the measurement (sprains, talalgias, etc.).
  • Diseases of balance or motor control.
  • Surgeries in the last 12 months.
  • Taking medications that may affect the neuromuscular system.
  • Sports practice in the last 48 hours.

Treatment and study plan

Heel cups in different BMI index and its correlation to physical activity in children

Device

Procedure: Group with muscle retraction will use a 5 millimeter heel cups in 3 and 6 months

Primary outcomes

  1. Stabilometry

    Time frame: pre intervention, 3 months post intervention, 6 months post intervention

    The measurements were conducted in the primary school of participating schools at a temperature of 22 ◦C, in the same hour of the day. To assess participants' balance, the anthropometric position of the protocol proposed by the International Society for the Advancement of Cineatropometry (ISAK) was assigned: participants placed their mi Frankfort; the upper limbs remained relaxed throughout the body, with palms facing forward and thumbs separated from the rest of the toes, and were barefoot with feet externally rotated f 30 degrees and with a heel distance of 4cm. The children were wearing sports costumes to contribute their free movement. For stabilometry data collection will use an inertial measurement instrument called Gyko® It is a state-of-the-art device that allows to measure an objective assessment of acceleration, angular velocity and with an acquisition frequency of 100Hz

  2. heel cups in muscle retraction

    Time frame: Pre intervention, 3 months post intervention, 6 months post intervention.

    Orthopaedic treatment of calf muscle retraction is defined as heel cup. A 5mm heel cup height was applied. Made of ethyl vinyl acetate material with a hard shore A 65º. The main function of a heel pad was to provide a slight change in heel elevation

Secondary outcomes

  1. Lunge test

    Time frame: Pre intervention, 3 months post intervention, 6 months post intervention.

    To determine the dorsal flexion of the ankle, the Lunge Test was used. Through the Leg MOtion® system

  2. Physical Activity Questionnaire for Children (PAQ-C)

    Time frame: Pre intervention, 3 months post intervention, 6 months post intervention

    The Spanish version of the Physical Activity Questionnaire for Children (PAQ-C) validated by Manchola- will be used to collect data on the type and amount of physical activity performed by the participants

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Registry information

Official study title

Stability Effects After Heel Cups Orthopedics Treatment in Different BMI Index and Its Correlation to Physical Activity in Children. A Longitudinal Intervention Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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