NCT03997955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

June 23, 2019

Last Update Submit

September 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Foot plantar pressure area

    Foot plantar pressure area measured by the Balance Evaluation Systems test (squared centimeters)

    Change from foot plantar pressure area at 2 minutes

Secondary Outcomes (1)

  • Center of pressure area

    Change from center of pressure area at 2 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

Myofascial induction

Other: Myofascial induction

Control group

SHAM COMPARATOR

Sham myofascial induction

Other: Sham myofascial induction

Interventions

Myofascial induction in plantar fascia

Experimental group

Sham myofascial induction in plantar fascia

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Eva María Martínez

Madrid, 28700, Spain

Location

Related Publications (1)

  • Martinez-Jimenez EM, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Diaz-Velazquez JI, Palomo-Lopez P, Rodriguez-Sanz D, Calvo-Lobo C, Lopez-Lopez D. Pressure and Traction Technique Improves Postural Control More Than Tactile Stimulation in Foot Plantar Fascia: A Randomized Single-Blind Trial. Arch Phys Med Rehabil. 2020 Jun;101(6):978-984. doi: 10.1016/j.apmr.2020.01.017. Epub 2020 Feb 28.

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
Principal Investigator

Study Record Dates

First Submitted

June 23, 2019

First Posted

June 25, 2019

Study Start

June 25, 2019

Primary Completion

September 5, 2019

Study Completion

September 10, 2019

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations