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

Ankle Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05902949
• Other study ID #: UCV/2017-2018//113
• Status: Completed
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 27, 2023

Study information

• Verified date: January 2024
• Source: Fundación Universidad Católica de Valencia San Vicente Mártir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 27, 2023
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Disease

Intervention

Procedure:
• Streching Group
The Streching group will perform a conventional stretching exercise.
• Heel group
The heel pad group will be applied a plantar support during the months of the study.

Locations

Country	Name	City	State
Spain	Javier Ferrer Torregrosa	Torrent	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universidad Católica de Valencia San Vicente Mártir

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	At baseline; post 1 (3 months) and post 2 (6 months)
Secondary	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	At baseline; post 1 (3 months) and post 2 (6 months)
Secondary	Lunge Test	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)