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Ankle DiseaseNCT05902949

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

A study testing Streching Group and Heel group in people with Ankle Disease, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Ankle Disease
What is being tested?
Streching Group and Heel group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteSpain
Study dates
15 Jun 2023to 27 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children 8-12 years old
  • Regular sports practice
  • Decreased range of flexión

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Javier Ferrer Torregrosa

    Torrent, Valencia, 46900

Other trials in Spain

About this study

Official title: 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

Read the 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.

Conditions
Ankle Disease
Being tested
Streching Group, Heel group
Keywords
Muscle Stretching Exercises, Balance, Exercise, Range of Motion
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Streching GroupProcedure or surgery

    The Streching group will perform a conventional stretching exercise.

  • Heel groupProcedure or surgery

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

Study groups in NCT05902949
Study groupRoleWhat they receive
Stretching GroupActive comparatorThe 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.
Receives: Procedure: Streching Group
Heel Cup GroupActive comparatorThe heel cup will be 5mm high (Eva Shore 65)
Receives: Procedure: Heel group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. Stabilometry

    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

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

  2. Instability test

    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

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

  3. Lunge Test

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start15 Jun 2023
  3. Primary completion27 Dec 2023
  4. Study completion27 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05902949
Sponsor's protocol ID
UCV/2017-2018//113
Status last verified
Jan 2024
First submitted
29 Nov 2022
Last updated
17 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32927763

  • 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.

    PubMed 30870009

  • 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.

    PubMed 35366430

  • 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.

    PubMed 19232750

  • 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.

    PubMed 20843744

  • 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.

    PubMed 26583139

  • 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.

    PubMed 27662790

  • 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.

    PubMed 40253482

Questions about this trial

What is this clinical trial studying?

A study testing Streching Group and Heel group in people with Ankle Disease, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05902949, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.

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