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

January 15, 2024 updated by: Fundación Universidad Católica de Valencia San Vicente Mártir

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

150

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 Contact

Study Contact Backup

Study Locations

  • Spain
    • Valencia
      • Torrent, Valencia, Spain, 46900
        • Javier Ferrer Torregrosa

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stretching Group
The pattern will be performed 3 times per day (10 repetitions, 30 seconds each repetition). A daily control diary will be filled in when performing the exercise.
Procedure: Streching Group
The Streching group will perform a conventional stretching exercise.
Active Comparator: Heel Cup Group
The heel cup will be 5mm high (Eva Shore 65)
Procedure: Heel group
The heel pad group will be applied a plantar support during the months of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline; post 1 (3 months) and post 2 (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline; post 1 (3 months) and post 2 (6 months)
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
At baseline; post 1 (3 months) and post 2 (6 months)
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
At baseline; post 1 (3 months) and post 2 (6 months)

Collaborators and Investigators

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

Sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

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)

June 15, 2023

Primary Completion (Actual)

December 27, 2023

Study Completion (Actual)

December 27, 2023

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 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.

Clinical Trials on Ankle Disease

Clinical Trials on Streching Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe