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Myofascial Induction Effects on Plantar Pressures and Stabilometry

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ClinicalTrials.gov Identifier: NCT03997955
Recruitment Status : Active, not recruiting
First Posted : June 25, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
César Calvo Lobo, Universidad de León

Tracking Information
First Submitted Date  ICMJE June 23, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE June 25, 2019
Estimated Primary Completion Date August 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
Foot plantar pressure area [ Time Frame: Change from foot plantar pressure area at 2 minutes ]
Foot plantar pressure area measured by the Balance Evaluation Systems test (squared centimeters)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03997955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
Center of pressure area [ Time Frame: Change from center of pressure area at 2 minutes ]
Center of pressure area measured by the Balance Evaluation Systems test (squared centimeters)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myofascial Induction Effects on Plantar Pressures and Stabilometry
Official Title  ICMJE Myofascial Induction Effects on Plantar Pressures and Stabilometry Variables. A Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Foot Diseases
  • Myofascial Pain
Intervention  ICMJE
  • Other: Myofascial induction
    Myofascial induction in plantar fascia
  • Other: Sham myofascial induction
    Sham myofascial induction in plantar fascia
Study Arms  ICMJE
  • Experimental: Experimental group
    Myofascial induction
    Intervention: Other: Myofascial induction
  • Sham Comparator: Control group
    Sham myofascial induction
    Intervention: Other: Sham myofascial induction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 24, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 20, 2019
Estimated Primary Completion Date August 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03997955
Other Study ID Numbers  ICMJE Myofascial-Induction_CT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party César Calvo Lobo, Universidad de León
Study Sponsor  ICMJE Universidad de León
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidad de León
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP