AzTrials
AzTrials

HealthyNCT04201795

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

A study testing Laser and pressure and traction tecnique in people with Healthy and Foot, run by Mayuben Private Clinic at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Foot, Manual Therapy
What is being tested?
Laser and pressure and traction tecnique
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSpain
Study dates
29 Nov 2019to 29 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy individuals
  • Must have no pain

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Mayuben Clinic

    San Sebastián de los Reyes, Madrid, 28702

Other trials in Spain

About this study

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

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.

Read the 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).

Being tested
Laser, pressure and traction tecnique
Keywords
fascia, myofascial, plantar fascia, postural balance, stabilometry, platform

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaserOther

    laser with no emision will applied

  • pressure and traction tecniqueOther

    pressure and traction in plantar fascia with hands will be applied

Study groups in NCT04201795
Study groupRoleWhat they receive
pressure and tractionExperimentalpressure and traction durin 5 minutes will be applied in plantar fascia
Receives: Other: pressure and traction tecnique
LaserSham comparatorApplied during 5 minutes each plantar fascia of sham laser
Receives: Other: Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. static footprint

    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

    Measured: Through study completion, an average of 1 month

  2. stabilometry variables eyes open

    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

    Measured: Through study completion, an average of 1 month

  3. stabilometry variables eyes closed

    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

    Measured: Through study completion, an average of 1 month

Secondary outcomes (3)

  1. static footprint after intervention

    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

    Measured: Through study completion, an average of 1 month

  2. stabilometry variables eyes open after intervention

    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

    Measured: Through study completion, an average of 1 month

  3. stabilometry variables eyes after intervention

    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

    Measured: Through study completion, an average of 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2019
  2. Study start29 Nov 2019
  3. Primary completion30 Dec 2019
  4. Study completion29 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
two arms parallel ( intervention and control) will be randomized asigned to compare pressure and traction tecnique versus laser placebo
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04201795
Sponsor's protocol ID
2111201814518
Status last verified
Jan 2020
First submitted
9 Dec 2019
Last updated
31 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. Foot (Edinb). 2014 Jun;24(2):66-71. doi: 10.1016/j.foot.2014.03.005. Epub 2014 Mar 21.

    PubMed 24703512

  • Ajimsha MS, Chithra S, Thulasyammal RP. Effectiveness of myofascial release in the management of lateral epicondylitis in computer professionals. Arch Phys Med Rehabil. 2012 Apr;93(4):604-9. doi: 10.1016/j.apmr.2011.10.012. Epub 2012 Jan 10.

    PubMed 22236639

  • Ichikawa K, Takei H, Usa H, Mitomo S, Ogawa D. Comparative analysis of ultrasound changes in the vastus lateralis muscle following myofascial release and thermotherapy: a pilot study. J Bodyw Mov Ther. 2015 Apr;19(2):327-36. doi: 10.1016/j.jbmt.2014.11.018. Epub 2014 Dec 23.

    PubMed 25892389

  • Hyland MR, Webber-Gaffney A, Cohen L, Lichtman PT. Randomized controlled trial of calcaneal taping, sham taping, and plantar fascia stretching for the short-term management of plantar heel pain. J Orthop Sports Phys Ther. 2006 Jun;36(6):364-71. doi: 10.2519/jospt.2006.2078.

    PubMed 16776486

  • Lee M, Kim M, Oh S, Choi YJ, Lee D, Lee SH, Yoon B. A self-determination theory-based self-myofascial release program in older adults with myofascial trigger points in the neck and back: A pilot study. Physiother Theory Pract. 2017 Sep;33(9):681-694. doi: 10.1080/09593985.2017.1345024. Epub 2017 Jul 17.

    PubMed 28715296

Questions about this trial

What is this clinical trial studying?

A study testing Laser and pressure and traction tecnique in people with Healthy and Foot, run by Mayuben Private Clinic at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

static footprint (time frame: Through study completion, an average of 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04201795, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in