Stability Effects After Heel Cups Orthopedics Treatment in Different BMI

September 16, 2024 updated by: Vicenta Martínez Córcoles, Universidad Miguel Hernandez de Elche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Albacete
      • Munera, Albacete, Spain, 02612
        • Colegio Publico Cervantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Children 8-12 years old
  2. Regular sports practice
  3. Decreased range of flexión

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Comparator: Heel Cup in muscle retraction
The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily Active Comparator: Heel Cup Group The heel cup will be 5mm high (Eva Shore 65) en 3 month and 6 month.
Device: Heel cups in different BMI index and its correlation to physical activity in children
Procedure: Group with muscle retraction will use a 5 millimeter heel cups in 3 and 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre intervention, 3 months post intervention, 6 months post intervention
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
Pre intervention, 3 months post intervention, 6 months post intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre intervention, 3 months post intervention, 6 months post intervention.
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
Pre intervention, 3 months post intervention, 6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Miguel Hernandez de Elche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2024

Primary Completion (Actual)

July 20, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCV/2017-2018/113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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