NCT04628286

Brief Summary

The objective is to determine the effectiveness of myofascial induction effects on stabilometric variables. Forty healthy subjects will be recruited for a single blind clinical trial. All subjects will be randomly distributed into two different groups: control group (simulated laser) and experimental group (myofascial induction). Result measurements will be performed in the center of the pressure area (stabilometry) using a validated platform. Two trials will be recorded for each condition (eyes closed and eyes open)

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 Nov 2020

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

November 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2020

Completed
Last Updated

December 3, 2020

Status Verified

November 1, 2020

Enrollment Period

7 days

First QC Date

November 7, 2020

Last Update Submit

December 2, 2020

Conditions

Outcome Measures

Primary Outcomes (20)

  • Stabilometry variable eyes open before Sham Laser or Myofascial Induction

    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 from the midline. Stabilometric variables measure the displacement of the center of pressures in X (in millimeters) with the eyes open.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes open before Sham Laser or Myofascial indution

    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 30º from the midline. The stabilometry variables measure the displacement of the center of pressures in Y (in millimeters) with the eyes open.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes open before Sham Laser or Myofascial indution

    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 Sham Laser or Myofascial indution

    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 30º from the midline. Stabilometric variables measure the center of pressure and the velocity displacement of the anteroposterior direction (a-p) (in millimeters / second).

    Through study completion, an average of 1 week

  • Stabilometry variables eyes open before Sham Laser or Myofascial indution

    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 30º from the midline. Stabilometric variables measure center of pressure, velocity, and lateral-lateral (lat-lat) direction displacement (in millimeters / second).

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed before Sham Laser or Myofascial indution

    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 from the midline. The stabilometric variables measure the displacement of the center of pressures in X (in millimeters) with the eyes closed.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed before Sham Laser or Myofascial indution

    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 30º from the midline. The stabilometry variables measure the displacement of the center of pressures in Y (in millimeters) with the eyes closed.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed before Sham Laser or Myofascial indution

    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 30º from the midline. The stabilometry variables measure the displacement of the area of the center of pressure (COP) (in millimeters²) with the eyes closed.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed before Sham Laser or Myofascial indution

    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 30º from the midline. Stabilometric variables measure the center of pressure and the velocity displacement of the anteroposterior direction (a-p) (in millimeters / second).

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed before Sham Laser or Myofascial indution

    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 30º from the midline. Stabilometric variables measure center of pressure, velocity, and lateral-lateral (lat-lat) direction displacement (in millimeters / second).

    Through study completion, an average of 1 week

  • Stabilometry variables eyes open after Sham Laser or Myofascial Induction

    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 30º from the midline. Stabilometric variables measure the displacement of the center of pressures in X (in millimeters) with the eyes open.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes open after Sham Laser or Myofascial Induction

    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 30º from the midline. The stabilometry variables measure the displacement of the center of pressures in Y (in millimeters) with the eyes open.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes open after Sham Laser or Myofascial Induction

    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 from the midline. Stabilometric variables measure the displacement of the area of the center of pressure (COP) (in millimeters²) with the eyes open.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes open after Sham Laser or Myofascial Induction

    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 30º from the midline. Stabilometric variables measure the center of pressure and the velocity displacement of the anteroposterior direction (a-p) (in millimeters / second).

    Through study completion, an average of 1 week

  • Stabilometry variables eyes open after Sham Laser or Myofascial Induction

    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 30º from the midline. Stabilometric variables measure center of pressure, velocity, and lateral-lateral (lat-lat) direction displacement (in millimeters / second).

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed after Sham Laser or Myofascial Induction

    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 30º from the midline. The stabilometric variables measure the displacement of the center of pressures in X (in millimeters) with the eyes closed.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed after Sham Laser or Myofascial Induction

    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 from the midline. The stabilometry variables measure the displacement of the center of pressures in Y (in millimeters) with the eyes closed.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed after Sham Laser or Myofascial Induction

    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 30º from the midline. Stabilometric variables measure the displacement of the area of the center of pressure (COP) (in millimeters²) with the eyes closed.

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed after Sham Laser or Myofascial Induction

    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 from the midline. Stabilometry variables measure the center of pressure, the velocity displacement from the anteroposterior direction (a-p) (in millimeters / second).

    Through study completion, an average of 1 week

  • Stabilometry variables eyes closed after Sham Laser or Myofascial Induction

    tabilometry 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 30º from the midline. Stabilometric variables measure center of pressure, velocity, and lateral-lateral (lat-lat) direction displacement (in millimeters / second).

    Through study completion, an average of 1 week

Study Arms (2)

Sham Laser

PLACEBO COMPARATOR

Placebo laser application in plantar fascia

Other: Sham Laser

Experimental group Myofascial Induction

EXPERIMENTAL

Myofascial Induction technique application in plantar fascia

Other: Myofascial Induction

Interventions

Sham Laser in plantar fascia

Sham Laser

Myofascial Induction in plantar fascia

Experimental group Myofascial Induction

Eligibility Criteria

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

You may qualify if:

  • Healthy individuals without pain.

You may not qualify if:

  • Previous lower extremities surgery
  • History of lower extremities injury with residual symptoms within the last year
  • Evidence of a leg-length discrepancy of more than 1 cm
  • Evidence of balance deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayuben Clinic

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

MeSH Terms

Conditions

Foot Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesSkin DiseasesSkin and Connective Tissue Diseases

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

November 7, 2020

First Posted

November 13, 2020

Study Start

November 20, 2020

Primary Completion

November 27, 2020

Study Completion

December 2, 2020

Last Updated

December 3, 2020

Record last verified: 2020-11

Locations