Stability Effects After Heel Cups Orthopedics Treatment in Different BMI

NCT06510933 | Completed

• 1 other identifier: UCV/2017-2018/113
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Range of Motion

Keywords

BALANCE; HEEL CUPS; RANGE OF MOTION; PHYSICAL ACTIVITY

Outcome Measures

Primary Outcomes (2)

• Stabilometry

  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

  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 Outcomes (2)

• Lunge test

  Pre intervention, 3 months post intervention, 6 months post intervention.

• Physical Activity Questionnaire for Children (PAQ-C)

  Pre intervention, 3 months post intervention, 6 months post intervention

Study Arms (1)

Active Comparator: Heel Cup in muscle retraction

EXPERIMENTAL

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

Interventions

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

Active Comparator: Heel Cup in muscle retraction

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Colegio Publico Cervantes

Munera, Albacete, 02612, Spain

Location

Related Publications (11)

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  PMID: 19246771 RESULT

• D'Hondt E, Deforche B, De Bourdeaudhuij I, Gentier I, Tanghe A, Shultz S, Lenoir M. Postural balance under normal and altered sensory conditions in normal-weight and overweight children. Clin Biomech (Bristol). 2011 Jan;26(1):84-9. doi: 10.1016/j.clinbiomech.2010.08.007. Epub 2010 Sep 17.

  PMID: 20850213 RESULT

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  PMID: 38398370 RESULT

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  PMID: 38218828 RESULT

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  PMID: 35126307 RESULT

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  PMID: 16882817 RESULT

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  PMID: 20233151 RESULT

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  PMID: 25719919 RESULT

• Martinez-Corcoles V, Nieto-Gil P, Ramos-Petersen L, Ferrer-Torregrosa J. Balance performance analysis after the COVID-19 quarantine in children aged between 8 and 12 years old: Longitudinal study. Gait Posture. 2022 May;94:203-209. doi: 10.1016/j.gaitpost.2022.03.019. Epub 2022 Mar 27.

  PMID: 35366430 RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator PhD

Model Details: Longitudinal

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 19, 2024
• Study Start: January 7, 2024
• Primary Completion: July 20, 2024
• Study Completion: July 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)