NCT03312101

Brief Summary

Introduction: The prevalence of biomechanical alterations in the the lower limbs in school-age children is increasing. The aim of this study is to assess the effectiveness of a therapeutic exercise program in child athletes with lower limb overpronation during gait. Methods: Relevant databases (PubMed and SCOPUS) were searched. A total of 123 young athletes (aged 9-12 years) will be evaluated. Subjects will be tested biomechanical analysis including all relevant angles, as follows: the Helbing angle, the femorotibial angle, and the Fick angle in both limbs. Subjects will be divided into two groups at random. Children in experimental group will participate in an exercise program for three months. Children in control group will not received treatment for three months. After the study, these children will receive the same treatment as children in experimental group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

Same day

First QC Date

September 19, 2017

Last Update Submit

May 1, 2018

Conditions

Keywords

exercise program

Outcome Measures

Primary Outcomes (1)

  • lower limb pronation reduction

    anthropometric parameters (Fick angle)

    3 months

Study Arms (2)

Experimental

EXPERIMENTAL

exercise program

Other: exercise program

Control

NO INTERVENTION

observation

Interventions

functional exercises consisting of a therapeutic exercise program based on concentric strengthening the gluteal muscles (maximus, medius and minimus) , the tensor fasciae latae muscle and the pyramidal muscle; ischiotibial muscle stretching ; and empowerment in eccentric and stretching of the gastrocnemius muscle, soleus muscle, tibialis posterior muscle and flexor of the big toe muscle,

Experimental

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • being 9-12 years of age
  • having being federated for at least two years (to be a member of the Andalusian Rugby Federation)
  • training at least two hours three days a week;
  • having lower limb overpronation (Fick angle \<12º, femorotibial angle \<170º and Helbing angle \<175º)

You may not qualify if:

  • lower limb asymmetry
  • biomechanical alteration secondary to an acute disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gabriel Domínguez-Maldonado

Seville, 41009, Spain

RECRUITING

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Gabriel Domínguez-Maldonado, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel asigmanet
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2017

First Posted

October 17, 2017

Study Start

June 1, 2018

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations