NCT05902949

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

November 29, 2022

Last Update Submit

January 15, 2024

Conditions

Ankle Disease

Keywords

Muscle Stretching ExercisesBalanceExerciseRange of Motion

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of Physical Activity Questionnaire for Children (PAQ-C) at 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 Outcomes (3)

  • Stabilometry

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

  • Instability test

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

  • Lunge Test

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

Study Arms (2)

Stretching Group

ACTIVE COMPARATOR

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

Heel Cup Group

ACTIVE COMPARATOR

The heel cup will be 5mm high (Eva Shore 65)

Procedure: Heel group

Interventions

Streching GroupPROCEDURE

The Streching group will perform a conventional stretching exercise.

Stretching Group
Heel groupPROCEDURE

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

Heel Cup Group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Javier Ferrer Torregrosa

Torrent, Valencia, 46900, Spain

Location

Related Publications (8)

  • Garcia-Soidan JL, Garcia-Lineira J, Leiros-Rodriguez R, Soto-Rodriguez A. Physical Activity Practice and Optimal Development of Postural Control in School Children: Are They Related? J Clin Med. 2020 Sep 10;9(9):2919. doi: 10.3390/jcm9092919.

    PMID: 32927763BACKGROUND

  • Vallandingham RA, Gaven SL, Powden CJ. Changes in Dorsiflexion and Dynamic Postural Control After Mobilizations in Individuals With Chronic Ankle Instability: A Systematic Review and Meta-Analysis. J Athl Train. 2019 Apr;54(4):403-417. doi: 10.4085/1062-6050-380-17. Epub 2019 Mar 14.

    PMID: 30870009BACKGROUND

  • 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: 35366430BACKGROUND

  • Hsu YS, Kuan CC, Young YH. Assessing the development of balance function in children using stabilometry. Int J Pediatr Otorhinolaryngol. 2009 May;73(5):737-40. doi: 10.1016/j.ijporl.2009.01.016. Epub 2009 Feb 20.

    PMID: 19232750BACKGROUND

  • Hoch MC, Staton GS, McKeon PO. Dorsiflexion range of motion significantly influences dynamic balance. J Sci Med Sport. 2011 Jan;14(1):90-2. doi: 10.1016/j.jsams.2010.08.001. Epub 2010 Sep 16.

    PMID: 20843744BACKGROUND

  • Han J, Anson J, Waddington G, Adams R, Liu Y. The Role of Ankle Proprioception for Balance Control in relation to Sports Performance and Injury. Biomed Res Int. 2015;2015:842804. doi: 10.1155/2015/842804. Epub 2015 Oct 25.

    PMID: 26583139BACKGROUND

  • Grindstaff TL, Dolan N, Morton SK. Ankle dorsiflexion range of motion influences Lateral Step Down Test scores in individuals with chronic ankle instability. Phys Ther Sport. 2017 Jan;23:75-81. doi: 10.1016/j.ptsp.2016.07.008. Epub 2016 Jul 29.

    PMID: 27662790BACKGROUND

  • Martinez-Corcoles V, Garcia-Campos J, Vicente-Mampel J, Chicharro-Luna E, Jimenez EMM, Ferrer-Torregrosa J. Postural analysis of children with muscle retraction after six-month exercise or heel cup interventions in a randomized trial. Sci Rep. 2025 Apr 19;15(1):13578. doi: 10.1038/s41598-025-98527-6.

    PMID: 40253482DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2022

First Posted

June 15, 2023

Study Start

June 15, 2023

Primary Completion

December 27, 2023

Study Completion

December 27, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)