Myofascial Induction Effects on Plantar Pressures and Stabilometry

Sponsor

Universidad de León (Other)

Overall Status

Completed

CT.gov ID

NCT03997955

Collaborator

(none)

Enrollment

Location

Arms

2.5

Actual Duration (Months)

15.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective is to determine the effectiveness of myofascial Induction effects on plantar pressures and stabilometry variables. Forty healthy subjects (28 females and 12 males) will be recruited for a simple blind clinical trial. All subjects will be randomly distributed in two different groups: control group (sham treatment of myofascial Induction) and experimental group (myofascial Induction). Outcome measurements will be foot plantar pressure area (footprint) and center of pressure area (stabilometry) by the Balance Evaluation Systems test. Two trials will be recorded for each condition.

Condition or Disease	Intervention/Treatment	Phase
Foot Diseases Myofascial Pain	Other: Myofascial induction Other: Sham myofascial induction	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Myofascial Induction Effects on Plantar Pressures and Stabilometry Variables. A Clinical Trial

Actual Study Start Date :

Jun 25, 2019

Actual Primary Completion Date :

Sep 5, 2019

Actual Study Completion Date :

Sep 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Myofascial induction	Other: Myofascial induction Myofascial induction in plantar fascia
Sham Comparator: Control group Sham myofascial induction	Other: Sham myofascial induction Sham myofascial induction in plantar fascia

Arm

Intervention/Treatment

Experimental: Experimental group

Myofascial induction

Other: Myofascial induction

Myofascial induction in plantar fascia

Sham Comparator: Control group

Sham myofascial induction

Other: Sham myofascial induction

Sham myofascial induction in plantar fascia

Outcome Measures

Primary Outcome Measures

Foot plantar pressure area [Change from foot plantar pressure area at 2 minutes]
Foot plantar pressure area measured by the Balance Evaluation Systems test (squared centimeters)

Secondary Outcome Measures

Center of pressure area [Change from center of pressure area at 2 minutes]
Center of pressure area measured by the Balance Evaluation Systems test (squared centimeters)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eva María Martínez	Madrid		Spain	28700

Sponsors and Collaborators

Universidad de León

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

César Calvo Lobo, Principal Investigator, Universidad de León

ClinicalTrials.gov Identifier:

NCT03997955

Other Study ID Numbers:

Myofascial-Induction_CT

First Posted:

Jun 25, 2019

Last Update Posted:

Sep 11, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Foot Diseases

Study Results

No Results Posted as of Sep 11, 2019