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

Flatfoot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05873166
• Other study ID #: 1912202200923-A
• Status: Completed
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: May 2023
• Source: Mayuben Private Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 30, 2023
• Est. primary completion date: May 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Flatfoot

Intervention

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

Locations

Country	Name	City	State
Spain	Eva María Martínez-Jimenez	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Mayuben Private Clinic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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