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

Not Applicable

Completed

• Conditions: Foot; Healthy; Manual Therapy
• Interventions: Other: pressure and traction tecnique; Other: Laser

• Registration Number: NCT04201795
• Lead Sponsor: Mayuben Private Clinic

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.

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 Timeline

• Study Start: 2019-11-29
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-17
• Primary Completion: 2019-12-30
• Status Verified: 2020-01
• Study Completion: 2020-01-29
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pressure and traction	pressure and traction tecnique	pressure and traction durin 5 minutes will be applied in plantar fascia
Laser	Laser	Applied during 5 minutes each plantar fascia of sham laser

Primary Outcome Measures

Name	Time	Method
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 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
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

Secondary Outcome Measures

Name	Time	Method
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
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 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

Trial Locations

Locations (1)

Mayuben Clinic; 🇪🇸 San Sebastián De Los Reyes, Madrid, Spain