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Foot DiseasesNCT04628286

Myofascial Induction Effects on Stabilometry Versus Sham Laser

A study testing Myofascial Induction in people with Foot Diseases and Myofascial Pain, run by Mayuben Private Clinic at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Foot Diseases, Myofascial Pain
What is being tested?
Myofascial Induction
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteSpain
Study dates
20 Nov 2020to 2 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy individuals without pain.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Mayuben Clinic

    San Sebastián de los Reyes, Madrid, 28702

Other trials in Spain

About this study

Official title: Effects of Myofascial Induction Technique in Stabilometry Plantar Fascia Compared to a Placebo Laser

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)

Being tested
Sham Laser, Myofascial Induction
Medical subject headings
Foot Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sham LaserOther

    Sham Laser in plantar fascia

  • Myofascial InductionOther

    Myofascial Induction in plantar fascia

Study groups in NCT04628286
Study groupRoleWhat they receive
Sham LaserPlacebo comparatorPlacebo laser application in plantar fascia
Receives: Other: Sham Laser
Experimental group Myofascial InductionExperimentalMyofascial Induction technique application in plantar fascia
Receives: Other: Myofascial Induction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 1 week

  2. 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.

    Measured: Through study completion, an average of 1 week

  3. 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.

    Measured: Through study completion, an average of 1 week

  4. 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).

    Measured: Through study completion, an average of 1 week

  5. 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).

    Measured: Through study completion, an average of 1 week

  6. 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.

    Measured: Through study completion, an average of 1 week

  7. 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.

    Measured: Through study completion, an average of 1 week

  8. 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.

    Measured: Through study completion, an average of 1 week

  9. 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).

    Measured: Through study completion, an average of 1 week

  10. 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).

    Measured: Through study completion, an average of 1 week

  11. 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.

    Measured: Through study completion, an average of 1 week

  12. 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.

    Measured: Through study completion, an average of 1 week

  13. 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.

    Measured: Through study completion, an average of 1 week

  14. 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).

    Measured: Through study completion, an average of 1 week

  15. 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).

    Measured: Through study completion, an average of 1 week

  16. 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.

    Measured: Through study completion, an average of 1 week

  17. 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.

    Measured: Through study completion, an average of 1 week

  18. 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.

    Measured: Through study completion, an average of 1 week

  19. 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).

    Measured: Through study completion, an average of 1 week

  20. 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).

    Measured: Through study completion, an average of 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start20 Nov 2020
  3. Primary completion27 Nov 2020
  4. Study completion2 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04628286
Sponsor's protocol ID
2111201814518 C
Status last verified
Nov 2020
First submitted
7 Nov 2020
Last updated
3 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Myofascial Induction in people with Foot Diseases and Myofascial Pain, run by Mayuben Private Clinic at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stabilometry variable eyes open before Sham Laser or Myofascial Induction (time frame: Through study completion, an average of 1 week). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.

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