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Completed

NCT Number: NCT04201795

Effects of the Pressure and Traction Technique on the Plantar Footprint and Balance

The aim of this clinical trial is to check the effects of manual pressure and traction technique on balance and plantar footprint variables comparing with Laser placebo.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayuben Clinic

San Sebastián de los Reyes, Madrid, 28702, Spain

About this study

Forty healthy subjects wil be recruited for a simple blind study. Participants will be from 1 to 40 years old, not obese. Participants will be randomized into two groups. Experimental group performed a bilateral plantar fascia manual pressure and traction technique. Control group performed a laser placebo. The time duration (5 minutes), position, and therapist were the same for both treatments. The investigators will measure stabilometry variables and static footprint. The footprint variables will be divided in bilateral rear foot, bilateral midfoot, bilateral fore foot.

Measures. Stabilometry will be measured by displacement of the center of pressures in X and Y with eyes open and closed , center of pressure (COP) with eyes open and closed, COP area with eyes open and closed, COP antero-posterior (a-p) and medio-lateral (m-lat) directions with eyes open and closed, and COP speed. Two trials will be recorded for each condition and the order of the conditions will be randomized across subjects, eyes open and eyes closed. Foot plantar pressure and surface area of two static footprints will be measured during bipedal standing. Static plantar pressure will be evaluated by means of maximum pressure, medium pressure and surface area of each aspect of the foot (rearfoot, midfoot, and fore foot).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals
  • Must have no pain

Exclusion criteria

  • Previous lower extremities surgery.
  • History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.
  • Leg-length discrepancy more than 1 cm
  • Balance deficits (determined by oral questionnaire regarding falls)

Treatment and study plan

laser

Other

laser with no emision will applied

pressure and traction tecnique

Other

pressure and traction in plantar fascia with hands will be applied

Primary outcomes

  1. static footprint

    Time frame: Through study completion, an average of 1 month

    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

  2. stabilometry variables eyes open

    Time frame: Through study completion, an average of 1 month

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform (27), participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes open

  3. stabilometry variables eyes closed

    Time frame: Through study completion, an average of 1 month

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform (27), participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes closed

Secondary outcomes

  1. static footprint after intervention

    Time frame: Through study completion, an average of 1 month

    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

  2. stabilometry variables eyes open after intervention

    Time frame: Through study completion, an average of 1 month

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform (27), participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes open

  3. stabilometry variables eyes after intervention

    Time frame: Through study completion, an average of 1 month

    Stabilometry assessment was used and subjects were instructed to stand barefoot on the force platform (27), participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned at 30º away from the midline. During all the examinations, the upper limbs were placed in a relaxed position along the body. The subjects were instructed to stand as still as possible for 30 s, with their eyes open, while concentrating on a point at eye level 2-m away or with their eyes closed

Sponsors and collaborators

Lead sponsor

Mayuben Private Clinic

Other

Registry information

Official study title

Effects of the Pressure and Traction Technique on the Plantar Footprint and Balance Against a Placebo Laser: A Randomized Single Blind Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 17, 2019
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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