Evaluation of the Effect of a Clinical Exercise Programme on Plantar Distribution and Correction of Postural Asymmetries

October 16, 2024 updated by: Svitlana Dikhtyarenko, University of Beira Interior

Predicting Body Pain by Postural Related Problems in Middle-age and Older Adults Using Machine Learning

The aim of this study was to identify significant variables that contribute to the association between postural problems, plantar pressure distribution and levels of bodily pain in middle-aged and elderly adults. The researchers' hypothesis is that plantar pressure characteristics and postural asymmetries differ according to gender, are related to body composition and predict pain levels. The study described here is the only one to include variables that make it possible to identify body asymmetries in a postural analysis, based on the distribution of plantar pressure and body composition.

Study Overview

Detailed Description

The study employed an observational cross-sectional design. A convenience sample was recruited to analyse differences between men and women in anthropometrics, body composition, plantar pressure distribution, and pain levels. Without intervention, researchers observed and recorded data at a single time point, allowing comparisons between sexes and exploring correlations among the measured variables. This type of design allowed a snapshot view of the differences and associations present within the sample.

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rua Das Areias, 11 - 2
      • Setúbal, Rua Das Areias, 11 - 2, Portugal, 2910-407
        • Svitlana Dikhtyarenko

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The population of the present study consisted of 52 (n=52) participants of both sexes. The majority of study participants were female, comprising 67.3% (n=35), while 32.7 % of the sample were male (n=17). The mean age of participants was 57.35 years in males and 64.69 years in females.

Description

Inclusion criteria:

  • Participants had to be at least eighteen years old and physically fit. All participants had to complete the PAR-Q (health questionnaire), psychological well-being questionnaire (EBEP) and sign the free, informed and informed consent form (CLIE).

Exclusion criteria:

  • In order to reduce the risk of injury or aggravation of known diseases, the researchers chose the following exclusion criteria: serious orthopaedic problems (prosthesis fitting, recent orthopaedic surgery), reported neurological problems (requiring daily medication), cardiopulmonary diseases (pacemaker, use of oxygen cylinders) and pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
I
The 'M' point is on the heels of both feet.
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
II
The 'M' point is located on the heel of the left foot and the forefoot of the right foot.
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
III
Point 'M' is located on the heel of the right foot and the forefoot of the left foot.
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
IV
The point of maximum pressure is in the forefoot area of both feet.
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
V
The 'M' point is in the medial zone on both feet.
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
VI
The 'M' point is located on the left midfoot and right rearfoot.
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.
VII
The 'M' point is located on the right midfoot and left rearfoot.
At the beginning of the study, the participants underwent a baropodometric and photometric analysis. At the same time, anthropometric data and self-assessed body pain data were collected. For 12 continuous weeks, the participants completed a training programme that included specific exercises designed for each group. At the end, the baropodometry images were analysed again, which led to the final conclusion of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Importance and benefits of physical exercise in preventing pain and improving quality of life
Time Frame: 12 weeks
Sequencing of the training plan
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bodily pain and discomfort
Time Frame: 12 weeks
Relationship between posture and pain
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant changes in baropodometry images
Time Frame: 12 weeks
Physical exercise and changes in footsteps
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Pedro Mr Forte, PhD, University of Beira Interior
  • Study Director: Dulce Ms Esteves, PhD, University os Beira Interior

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

October 6, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CE-UBI-Pj-2023-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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