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

Sponsor
Fundación Universidad Católica de Valencia San Vicente Mártir (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05902949
Collaborator
(none)
160
Enrollment
2
Arms
6
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Streching Group
  • Procedure: Heel group
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Analysis of Postural Control in Children After of Exercise Therapy Versus Passive "Heel Pad" Treatment: Randomized Controlled Trial.
Anticipated Study Start Date :
Jun 28, 2023
Anticipated Primary Completion Date :
Dec 28, 2023
Anticipated Study Completion Date :
Dec 28, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

  1. Stabilometry [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fundación Universidad Católica de Valencia San Vicente Mártir

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fundación Universidad Católica de Valencia San Vicente Mártir
ClinicalTrials.gov Identifier:
NCT05902949
Other Study ID Numbers:
  • UCV/2017-2018//113
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundación Universidad Católica de Valencia San Vicente Mártir
Muscle Stretching Exercises
Balance
Exercise
Range of Motion

Study Results

No Results Posted as of Jun 15, 2023