Back to resultsMyofascial Induction Effects on Stabilometry Versus Sham Laser
Primary Purpose
Foot Diseases, Myofascial Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sham Laser
Myofascial Induction
Sponsored by
About this trial
This is an interventional treatment trial for Foot Diseases
Eligibility Criteria
Inclusion Criteria:
- Healthy individuals without pain.
Exclusion Criteria:
- 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
Sites / Locations
- Mayuben Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Sham Laser
Experimental group Myofascial Induction
Arm Description
Placebo laser application in plantar fascia
Myofascial Induction technique application in plantar fascia
Outcomes
Primary Outcome Measures
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.
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.
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.
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).
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).
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.
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.
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.
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).
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).
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.
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.
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.
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).
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).
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.
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.
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.
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04628286
First Posted
November 7, 2020
Last Updated
December 2, 2020
Sponsor
Mayuben Private Clinic
1. Study Identification
Unique Protocol Identification Number
NCT04628286
Brief Title
Myofascial Induction Effects on Stabilometry Versus Sham Laser
Official Title
Effects of Myofascial Induction Technique in Stabilometry Plantar Fascia Compared to a Placebo Laser
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
December 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayuben Private Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Diseases, Myofascial Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham Laser
Arm Type
Placebo Comparator
Arm Description
Placebo laser application in plantar fascia
Arm Title
Experimental group Myofascial Induction
Arm Type
Experimental
Arm Description
Myofascial Induction technique application in plantar fascia
Intervention Type
Other
Intervention Name(s)
Sham Laser
Intervention Description
Sham Laser in plantar fascia
Intervention Type
Other
Intervention Name(s)
Myofascial Induction
Intervention Description
Myofascial Induction in plantar fascia
Primary Outcome Measure Information:
Title
Stabilometry variable eyes open before Sham Laser or Myofascial Induction
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes open before Sham Laser or Myofascial indution
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes open before Sham Laser or Myofascial indution
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes open before Sham Laser or Myofascial indution
Description
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).
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes open before Sham Laser or Myofascial indution
Description
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).
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes closed before Sham Laser or Myofascial indution
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes closed before Sham Laser or Myofascial indution
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes closed before Sham Laser or Myofascial indution
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes closed before Sham Laser or Myofascial indution
Description
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).
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes closed before Sham Laser or Myofascial indution
Description
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).
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes open after Sham Laser or Myofascial Induction
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes open after Sham Laser or Myofascial Induction
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes open after Sham Laser or Myofascial Induction
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes open after Sham Laser or Myofascial Induction
Description
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).
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes open after Sham Laser or Myofascial Induction
Description
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).
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes closed after Sham Laser or Myofascial Induction
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes closed after Sham Laser or Myofascial Induction
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes closed after Sham Laser or Myofascial Induction
Description
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.
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes closed after Sham Laser or Myofascial Induction
Description
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).
Time Frame
Through study completion, an average of 1 week
Title
Stabilometry variables eyes closed after Sham Laser or Myofascial Induction
Description
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).
Time Frame
Through study completion, an average of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy individuals without pain.
Exclusion Criteria:
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
Facility Information:
Facility Name
Mayuben Clinic
City
San Sebastián De Los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Myofascial Induction Effects on Stabilometry Versus Sham Laser
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