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Completed

NCT Number: NCT05873166

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

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.

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Key information

Conditions

Flatfoot Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eva María Martínez-Jimenez

Madrid, 28702, Spain

About this study

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 with eyes closed and open.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Treatment and study plan

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

Other

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

Primary outcomes

  1. Stabilometry variables eyes open before pressure release (x)

    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.

  2. Stabilometry variables eyes open before pressure release (y)

    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 Y (in millimeters) with open eyes.

  3. Stabilometry variables eyes open before pressure release COP area

    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 Pressure (COP) area (in millimeters2) with eyes open.

  4. Stabilometry variables eyes open before pressure release COP a-p

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

  5. Stabilometry variables eyes open before pressure release COP lat-lat

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

  6. Stabilometry variables eyes closed after pressure release (x)

    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 eyes closed.

  7. Stabilometry variables eyes closed after pressure release (y)

    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 Y (in millimeters) with closed eyes.

  8. Stabilometry variables eyes closed after pressure release COP area

    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 Pressure (COP) area (in millimeters²) with eyes closed.

  9. Stabilometry variables eyes closed after pressure release COP a-p

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

  10. Stabilometry variables eyes closed after pressure release COP lat-lat

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

Sponsors and collaborators

Lead sponsor

Mayuben Private Clinic

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 24, 2023
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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