Clinical trial NCT06510933: Stability Effects After Heel Cups Orthopedics Treatment in Different BMI
Official title: Stability Effects After Heel Cups Orthopedics Treatment in Different BMI Index and Its Correlation to Physical Activity in Children. A Longitudinal Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Range of Motion
Keywords: BALANCE
HEEL CUPS
RANGE OF MOTION
PHYSICAL ACTIVITY
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 74
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stabilometry
timeFrame: pre intervention, 3 months post intervention, 6 months post intervention
measure: heel cups in muscle retraction
timeFrame: Pre intervention, 3 months post intervention, 6 months post intervention.
Secondary outcomes:
measure: Lunge test
timeFrame: Pre intervention, 3 months post intervention, 6 months post intervention.
measure: Physical Activity Questionnaire for Children (PAQ-C)
timeFrame: Pre intervention, 3 months post intervention, 6 months post intervention
Other outcomes:
Locations:
city: Munera
country: Spain
facility: Colegio Publico Cervantes
state: Albacete
Study officials:
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