Stability Effects After Heel Cups Orthopedics Treatment in Different BMI

NCT ID: NCT06510933

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-07

Study Completion Date

2024-07-30

Brief Summary

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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

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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.

Conditions

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Range of Motion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Longitudinal
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Double (Participant, Outcomes Assessor)

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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Vicenta Martínez Córcoles

Principal Investigator PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Colegio Publico Cervantes

Munera, Albacete, Spain

Site Status

Countries

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Spain

References

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D Hondt E, Deforche B, De Bourdeaudhuij I, Lenoir M. Relationship between motor skill and body mass index in 5- to 10-year-old children. Adapt Phys Activ Q. 2009 Jan;26(1):21-37. doi: 10.1123/apaq.26.1.21.

Reference Type RESULT
PMID: 19246771 (View on PubMed)

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.

Reference Type RESULT
PMID: 20850213 (View on PubMed)

Hermassi S, Ketelhut S, Konukman F, Ayari MA, Al-Marri S, Al Rawahi N, Bouhafs EG, Nigg CR, Schwesig R. Differences in Physical Activity, Sedentary Behavior, Health-Related Physical Performance Indices and Academic Achievement: A Comparative Study of Normal-Weight and Obese Children in Qatar. J Clin Med. 2024 Feb 13;13(4):1057. doi: 10.3390/jcm13041057.

Reference Type RESULT
PMID: 38398370 (View on PubMed)

Hommen JM, Batista JP, Bollheimer LC, Hildebrand F, Laurentius T, Siebers HL. Movement patterns during gait initiation in older adults with various stages of frailty: a biomechanical analysis. Eur Rev Aging Phys Act. 2024 Jan 13;21(1):1. doi: 10.1186/s11556-024-00335-w.

Reference Type RESULT
PMID: 38218828 (View on PubMed)

Barros WMA, da Silva KG, Silva RKP, Souza APDS, da Silva ABJ, Silva MRM, Fernandes MSS, de Souza SL, Souza VON. Effects of Overweight/Obesity on Motor Performance in Children: A Systematic Review. Front Endocrinol (Lausanne). 2022 Jan 20;12:759165. doi: 10.3389/fendo.2021.759165. eCollection 2021.

Reference Type RESULT
PMID: 35126307 (View on PubMed)

Pfeiffer M, Kotz R, Ledl T, Hauser G, Sluga M. Prevalence of flat foot in preschool-aged children. Pediatrics. 2006 Aug;118(2):634-9. doi: 10.1542/peds.2005-2126.

Reference Type RESULT
PMID: 16882817 (View on PubMed)

Nantel J, Mathieu ME, Prince F. Physical activity and obesity: biomechanical and physiological key concepts. J Obes. 2011;2011:650230. doi: 10.1155/2011/650230. Epub 2010 Nov 22.

Reference Type RESULT
PMID: 21113311 (View on PubMed)

Duncan MJ, Stanley M. Functional movement is negatively associated with weight status and positively associated with physical activity in british primary school children. J Obes. 2012;2012:697563. doi: 10.1155/2012/697563. Epub 2012 Mar 26.

Reference Type RESULT
PMID: 22545208 (View on PubMed)

Duncan MJ, Nevill A, Woodfield L, Al-Nakeeb Y. The relationship between pedometer-determined physical activity, body mass index and lean body mass index in children. Int J Pediatr Obes. 2010 Oct;5(5):445-50. doi: 10.3109/17477160903568421.

Reference Type RESULT
PMID: 20233151 (View on PubMed)

Mitchell UH, Johnson AW, Adamson B. Relationship between functional movement screen scores, core strength, posture, and body mass index in school children in Moldova. J Strength Cond Res. 2015 May;29(5):1172-9. doi: 10.1519/JSC.0000000000000722.

Reference Type RESULT
PMID: 25719919 (View on PubMed)

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.

Reference Type RESULT
PMID: 35366430 (View on PubMed)

Other Identifiers

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UCV/2017-2018/113

Identifier Type: -

Identifier Source: org_study_id

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