NCT04290065

Brief Summary

Fatigue influences the kinematics of the knee. Decreasing the tone of the suboccipital musculature may decrease the tone of the knee flexors. Inhibition of the suboccipital musculature is used to improve ischiosural muscle tension. The main objective of the study is to evaluate the effectiveness of the stretching of the miodural bridge in the modification of the posture in professional soccer players of 3rd division. Randomized clinical trial. 30 players will be randomized to the two study groups: experimental (technique of stretching technique of the miodural bridge) and control (without intervention). A blinded evaluator will perform three evaluations: pretreatment, post-treatment and follow-up. The study variables will be: modification of posture and weight distribution (plantar pressure platform). The sample distribution will be calculated using a Kolmogórov-Smirnov analysis. The changes after each evaluation will be analyzed with the t-student test of related samples and through an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula. After stretching the miodural bridge, it is expected to see improvement in posture changes.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 27, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

February 27, 2020

Last Update Submit

September 1, 2021

Conditions

Keywords

Hamstring muscleSoccerFlexibilityHip jointSuboccipital muscles

Outcome Measures

Primary Outcomes (1)

  • Change from baseline posture modification after treatment and at month

    An evaluation will be carried out with a pedometric platform. For the evaluation of plantar pressures, we use a plantar pressure platform (Podoprint® S10Pro model). This platform has 4,096 sensors, which allow a maximum pressure of 100 N / cm2 per sensor and has a sampling frequency of 150 Hz. All measurements will be made in accordance with international standards for anthropometric evaluation. All the evaluated players will adopt a relaxed and inert bipedal orthopedic position (arms held at the sides of the body, barefoot, with clothes that allowed to see the feet, legs and knees). With eyes open and looking at a fixed point, at a distance of 1.50 m for 20 seconds.

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Secondary Outcomes (1)

  • Change from baseline modification of the weight distribution after treatment and at month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

Experimental group

EXPERIMENTAL

The intervention will take place over a period of 4 weeks, with 2 weekly sessions, with an estimated execution time of 1.50 to 3 minutes each. A manual therapy technique of inhibition of the suboccipital musculature and an axial traction of the upper hemiarchy will be performed

Other: Manual therapy

Control group

NO INTERVENTION

Athletes included in the control group will not perform any intervention, continuing with their usual routine.

Interventions

The patient will be lying supine, relaxed. The physiotherapist, located at the patient's head, will cover the occipital bone with one hand while the palm of the hand will rest on the lambdoid suture, and the fingers will be introduced into the suboccipital space. The other hand, with a glove, will be inserted into the patient's oral cavity, resting respectively the index and middle fingers, each in an upper dental hemiarchy, on the chewing face of the tooth. An axial traction will be carried out until the three tension barriers of equal size between them are overcome, in an estimated time between 1.50 and 3 minutes. All manual therapy sessions will be performed by the same physiotherapist, following the same protocol and under the same conditions.

Experimental group

Eligibility Criteria

Age18 Years - 23 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Football players
  • Male
  • From 18 to 23 years old
  • That have a federation file in 3rd division in the Region of Murcia
  • That you don't have any acute lesions at the time of the study.

You may not qualify if:

  • Subjects that: present some relevant subacute or chronic pathology that may have a direct impact on the processes or structures related to the study who have neurological problems or related to the vestibular system
  • That receive a specific Physiotherapy training on any of the study regions
  • Not sign the informed consent document

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Madrid

Madrid, Comunity of Madrid, 28670, Spain

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2020

First Posted

February 28, 2020

Study Start

March 2, 2020

Primary Completion

May 20, 2020

Study Completion

June 10, 2020

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations