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

Sponsor

Mayuben Private Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT04201795

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Foot Manual Therapy	Other: Laser Other: pressure and traction tecnique	N/A

Detailed Description

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

two arms parallel ( intervention and control) will be randomized asigned to compare pressure and traction tecnique versus laser placebotwo arms parallel ( intervention and control) will be randomized asigned to compare pressure and traction tecnique versus laser placebo

Masking:

Single (Participant)

Masking Description:

single blind masking

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 29, 2019

Actual Primary Completion Date :

Dec 30, 2019

Actual Study Completion Date :

Jan 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pressure and traction pressure and traction durin 5 minutes will be applied in plantar fascia	Other: pressure and traction tecnique pressure and traction in plantar fascia with hands will be applied
Sham Comparator: Laser Applied during 5 minutes each plantar fascia of sham laser	Other: Laser laser with no emision will applied

Arm

Intervention/Treatment

Experimental: pressure and traction

pressure and traction durin 5 minutes will be applied in plantar fascia

Other: pressure and traction tecnique

pressure and traction in plantar fascia with hands will be applied

Sham Comparator: Laser

Applied during 5 minutes each plantar fascia of sham laser

Other: Laser

laser with no emision will applied

Outcome Measures

Primary Outcome Measures

static footprint [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
stabilometry variables eyes open [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
stabilometry variables eyes closed [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 Outcome Measures

static footprint after intervention [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
stabilometry variables eyes open after intervention [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
stabilometry variables eyes after intervention [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)