NCT05873166

Brief Summary

Thirty-six subjects randomly distributed between a pressure release intervention group and a control group whose intervention is a non-emission laser. All the subjects will be measured before and after the interventions of each group. The measurements will be made on a pressure platform to record the stabilometry variables.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 25, 2023

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

4 days

First QC Date

May 15, 2023

Last Update Submit

May 31, 2023

Conditions

Flatfoot

Keywords

Footstabilometrytrigger point

Outcome Measures

Primary Outcomes (10)

  • Stabilometry variables eyes open before pressure release (x)

    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

  • Stabilometry variables eyes open before pressure release (y)

    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 millimeters) with open eyes.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes open before pressure release COP area

    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 millimeters2) with eyes open.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes open before pressure release COP a-p

    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 millimeters/second).

    Through study completion, an average of 1 week

  • Stabilometry variables eyes open before pressure release COP lat-lat

    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 millimeters/second).

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed after pressure release (x)

    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 eyes closed.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed after pressure release (y)

    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 millimeters) with closed eyes.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed after pressure release COP area

    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 millimeters²) with eyes closed.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed after pressure release COP a-p

    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 millimeters/second).

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed after pressure release COP lat-lat

    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 millimeters/second).

    Through study completion, an average of 1 week

Study Arms (2)

Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point

EXPERIMENTAL

Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point

Other: Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point

Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

SHAM COMPARATOR
Other: Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

Interventions

Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger pointOTHER

Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point

Bilateral pressure release in Flexor Brevis Digitorum in subjects with latent trigger point
Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis MuscleOTHER

Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

Bilateral non emission Laser in latent trigger points of the Flexor digitorum Brevis Muscle

Eligibility Criteria

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

You may qualify if:

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

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-Jimenez

Madrid, 28702, Spain

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Eva María Martínez-Jimenez, PhD

    Mayuben Private Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Podiatry, Principal Investigator, and Physiotherapist.

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 24, 2023

Study Start

May 25, 2023

Primary Completion

May 29, 2023

Study Completion

May 30, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

ES(1)