Back to resultsMyofascial Induction Effects on Plantar Pressures and Stabilometry
Primary Purpose
Foot Diseases, Myofascial Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Myofascial induction
Sham 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
- Eva María Martínez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group
Control group
Arm Description
Myofascial induction
Sham myofascial induction
Outcomes
Primary Outcome Measures
Foot plantar pressure area
Foot plantar pressure area measured by the Balance Evaluation Systems test (squared centimeters)
Secondary Outcome Measures
Center of pressure area
Center of pressure area measured by the Balance Evaluation Systems test (squared centimeters)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03997955
Brief Title
Myofascial Induction Effects on Plantar Pressures and Stabilometry
Official Title
Myofascial Induction Effects on Plantar Pressures and Stabilometry Variables. A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
September 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de León
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 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.
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
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Myofascial induction
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Sham myofascial induction
Intervention Type
Other
Intervention Name(s)
Myofascial induction
Intervention Description
Myofascial induction in plantar fascia
Intervention Type
Other
Intervention Name(s)
Sham myofascial induction
Intervention Description
Sham myofascial induction in plantar fascia
Primary Outcome Measure Information:
Title
Foot plantar pressure area
Description
Foot plantar pressure area measured by the Balance Evaluation Systems test (squared centimeters)
Time Frame
Change from foot plantar pressure area at 2 minutes
Secondary Outcome Measure Information:
Title
Center of pressure area
Description
Center of pressure area measured by the Balance Evaluation Systems test (squared centimeters)
Time Frame
Change from center of pressure area at 2 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 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
Eva María Martínez
City
Madrid
ZIP/Postal Code
28700
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
32113972
Citation
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.
Results Reference
derived
Learn more about this trial
Myofascial Induction Effects on Plantar Pressures and Stabilometry
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