Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser.

July 28, 2024 updated by: EVA MARIA MARTÍNEZ JIMENEZ, Mayuben Private Clinic

Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial

In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on stabilometric variables that support static equilibrium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on the stabilometric variables that support static balance. To test the effects on balance.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28702
        • Eva María Martínez-Jiménez In Mayuben CLinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Healthy individuals
  • Must have latent trigger point in Flexor Brevis Digitorum muscles with no other pathologies.

Exclusion Criteria:

  • Previous lower extremities surgery.
  • History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.
  • Leg-length discrepancy more than 1 cm
  • Balance deficits (determined by oral questionnaire regarding falls)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pressure release
Application of pressure on the trigger point of the flexor digitorum brevis until remission of referred pain for a minimum of 90 seconds, at least 3 cycles.
Other: Preassure release
Preassure release in Flexor digitorum brevis trigger point muscle.
Sham Comparator: Non-emision Laser
Application of a non-emitting laser for 5 minutes on the trigger point of the flexor digitorum brevis muscle.
Other: Non-emision laser
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1.Stabilometric variable x displacement open eyes before pressure release.
Time Frame: Through study completion, an average of 1 week.
Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in X (in millimeters) with open eyes.
Through study completion, an average of 1 week.
2.Stabilometric variable x displacement open eyes before non emission Laser
Time Frame: Through study completion, an average of 1 week.
Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with open eyes.
Through study completion, an average of 1 week.
3.Stabilometric variable center of pressure area open eyes before pressure release.
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with eyes open.
Through study completion, an average of 1 week.
4.Stabilometric variable center of pressure area open eyes before non emission laser.
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with eyes open.
Through study completion, an average of 1 week.
5.Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction open eyes before pressure release.
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).
Through study completion, an average of 1 week.
6.Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction open eyes before pressure non-emission Laser.
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).
Through study completion, an average of 1 week.
7.Stabilometric variable y displacement open eyes before pressure release
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with open eyes.
Through study completion, an average of 1 week.
8.Stabilometric variable x displacement open eyes before non emission Laser
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure displacement of the center of pressures in Y (in millimeters) with open eyes.
Through study completion, an average of 1 week.
9.Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction open eyes before pressure release
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).
Through study completion, an average of 1 week.
10.Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction open eyes non emision Laser.
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometry variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).
Through study completion, an average of 1 week.
11.Stabilometric variable x displacement closed eyes before pressure release
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in X (in millimeters) with closed eyes.
Through study completion, an average of 1 week.
12.Stabilometric variable x displacement closed eyes before non emission Laser
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in X (in millimeters) with closed eyes.
Through study completion, an average of 1 week.
13.Stabilometric variable center of pressure area closed eyes before pressure release.
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with closed eyes.
Through study completion, an average of 1 week.
14.Stabilometric variable center of pressure area closed eyes before non emission laser.
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of Pressure (COP) area (in millimeters²) with closed eyes.
Through study completion, an average of 1 week.
15.5.Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction closed eyes before pressure release.
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).
Through study completion, an average of 1 week.
.Stabilometric variable center of pressure speed displacement of the anteroposterior(a-p) direction closed eyes before pressure non-emission Laser.
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the anteroposterior(a-p) direction (in millimeters/second).
Through study completion, an average of 1 week.
17.Stabilometric variable y displacement closed eyes before pressure release
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with closed eyes.
Through study completion, an average of 1 week.
18.Stabilometric variable x displacement closed eyes before non emission Laser
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure displacement of the center of pressures in Y (in millimeters) with closed eyes.
Through study completion, an average of 1 week.
9.Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction closed eyes before pressure release.
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).
Through study completion, an average of 1 week.
20. Stabilometric variable center of pressure speed displacement of the latero-lateral(lat-lat) direction closed eyes non emission Laser.
Time Frame: Through study completion, an average of 1 week.
Stabilometric assessment was used and subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. Stabilometric variables measure center of pressure speed displacement of the latero-lateral(lat-lat) direction (in millimeters/second).
Through study completion, an average of 1 week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayuben Private Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Actual)

July 24, 2024

Study Completion (Actual)

July 28, 2024

Study Registration Dates

First Submitted

July 7, 2024

First Submitted That Met QC Criteria

July 13, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 28, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1912202200923A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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