NCT05836142

Brief Summary

The aim of this clinical trial is to check the effects of progressive pressure release in the Flexor digitorum Brevis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

May 27, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

4 days

First QC Date

April 18, 2023

Last Update Submit

June 2, 2023

Conditions

Bilateral Latent Myofascial Trigger Points of Flexor Digitorum Brevis

Keywords

FootStabilometryPlatformtherapeuticstrigger point

Outcome Measures

Primary Outcomes (21)

  • Static footprint

    Static footprint will measure plantar presures and surface area of rear food, midfoot and fore foot. 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. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes open.

    Through study completion, an average of 3 days

  • Stabilometry variable x displacement open eyes before progressive pressure release

    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 milimeters) with open eyes.

    Through study completion, an average of 3 days

  • Stabilometry variable y displacement open eyes before progressive pressure release

    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 Y (in milimeters) with open eyes.

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure area open eyes before progressive pressure release

    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 Pressure (COP) area (in milimeters²) with eyes open.

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction open eyes before progressive pressure release

    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 center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction open eyes before progressive pressure release

    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 center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Through study completion, an average of 3 days

  • Stabilometry variable x displacement before progressive pressure release with closed eyes

    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 milimeters) with eyes closed.

    Through study completion, an average of 3 days

  • Stabilometry variable y displacement before progressive pressure release with closed eyes

    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 Y (in milimeters) with closed eyes.

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure area before progressive pressure release with closed eyes

    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 Pressure (COP) area (in milimeters²) with eyes closed.

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction before progressive pressure release with closed eyes

    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 center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction before progressive pressure release with closed eyes

    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 center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Through study completion, an average of 3 days

  • Stabilometry variable x displacement open eyes after intervention

    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 milimeters) with open eyes.

    Through study completion, an average of 3 days

  • Stabilometry variable y displacement open eyes after intervention

    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 Y (in milimeters) with open eyes.

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure area open eyes after intervention

    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 Pressure (COP) area (in milimeters²) with eyes open.

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction with open eyes after intervention

    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 center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction with open eyes after intervention

    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 center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Through study completion, an average of 3 days

  • Stabilometry variable x displacement with closed eyes after intervention

    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 milimeters) with eyes closed.

    Through study completion, an average of 3 days

  • Stabilometry variable y displacement with closed eyes after intervention

    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 Y (in milimeters) with closed eyes.

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure area with closed eyes after intervention

    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 Pressure (COP) area (in milimeters²) with eyes closed.

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure speed displacement of the anteroposterior(a-p) direction with closed eyes after intervention

    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 center of pressure speed displacement of the anteroposterior(a-p) direction (in milimeters/second).

    Through study completion, an average of 3 days

  • Stabilometry variable center of pressure speed displacement of the latero-lateral(lat-lat) direction with closed eyes after intervention

    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 center of pressure speed displacement of the latero-lateral(lat-lat) direction (in milimeters/second).

    Through study completion, an average of 3 days

Study Arms (1)

Experimental: progressive pressure release

EXPERIMENTAL

Bilateral progressive pressure release in latent trigger points of the Flexor digitorum Brevis Muscle

Procedure: progressive pressure release

Interventions

progressive pressure releasePROCEDURE

Bilateral progressive pressure release in latent trigger points of the Flexor digitorum Brevis Muscle

Experimental: progressive pressure release

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Asyntomatic subjects with flat foot

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eva María Martínez-Jiménez In Mayuben CLinic

Madrid, 28702, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pretest posttest of bilateral Flexor digitorum Brevis progressive pressure release intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Podiatry, Principal Investigator, and Physiotherapist

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 1, 2023

Study Start

May 27, 2023

Primary Completion

May 31, 2023

Study Completion

June 2, 2023

Last Updated

June 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)