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Completed

NCT Number: NCT05902949

Analysis of Postural Control in Children Suffering From Triceps Suralis Shortening.

The central nervous system (CNS) coordinates balance through the visual, vestibular, and somatoproprioceptive systems, which produce muscle activation for postural control. Among the important muscle activations for postural control are those produced in the ankle joint, which is crucial for maintaining postural control in sports settings, along with the gastrocnemius and soleus muscles. Studies show that children who practice sports improve their postural stability and accelerate sensory maturation, which can affect the development of the lower limb extremity, specifically the insertional musculature of the ankle and foot. The present study aims to analyze postural control in school-aged children with triceps suralis retraction and assess the effectiveness of treatment with stretching versus a heel pad for 3 and 6 months. Additionally, the study will analyze whether the physical activity the children engage in influences their stability

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Javier Ferrer Torregrosa

Torrent, Valencia, 46900, Spain

About this study

A randomized controlled trial will be conducted to evaluate the effectiveness of using a heel pad and a gastrocnemius and soleus stretching protocol. The outcomes of both interventions will be evaluated and compared, including pre-intervention and post-intervention assessments at 3 months and 6 months.

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

Streching Group

Procedure

The Streching group will perform a conventional stretching exercise.

Heel group

Procedure

The heel pad group will be applied a plantar support during the months of the study.

Primary outcomes

  1. Change from baseline of Physical Activity Questionnaire for Children (PAQ-C) at 6 months

    Time frame: At baseline; post 1 (3 months) and post 2 (6 months)

    The data on the type and amount of physical activity performed by the participants will be collected using the Spanish version of the Physical Activity Questionnaire for Children (PAQ-C) (Appendix 3). The PAQ-C has been validated by Manchola-González, Bagur-Calafat, and Girabent-Farrésby Manchola-González, Bagur-Calafat, and Girabent-Farrés will be used to collect data on the type and amount of physical activity performed by the participants.

Secondary outcomes

  1. Stabilometry

    Time frame: At baseline; post 1 (3 months) and post 2 (6 months)

    For collecting stabilometry data, an inertial measurement instrument called Gyko® (Janusz Jaworski et al., 2020) (Figure 5) will be used. It is a state-of-the-art device that allows for objective assessment of acceleration, angular velocity, and with an acquisition frequency of 100Hz

  2. Instability test

    Time frame: At baseline; post 1 (3 months) and post 2 (6 months)

    The instability test will be performed using a foam rubber pad model Balance _Pand Elite ® with dimensions of 50 x 41 x 6cm, a weight of 0.7kg, and a density of 55kg/m (Figure 6). The foam has a nominal density of 40kg/m3 and a vertical compressive strength of 0.45N mm2 and a vertical compressive elasticity of 34N mm2 according to the manufacturer

  3. Lunge Test

    Time frame: At baseline; post 1 (3 months) and post 2 (6 months)

    he Lunge Test will be used to determine the dorsal flexion of the ankle (Figure 10) using the Leg MOtion® system

Sponsors and collaborators

Lead sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Other

Registry information

Official study title

Analysis of Postural Control in Children After of Exercise Therapy Versus Passive "Heel Pad" Treatment: Randomized Controlled Trial.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Jan 17, 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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