This Study Highlights Differences in Baropodometry Between GendersNCT06647355
Evaluation of the Effect of a Clinical Exercise Programme on Plantar Distribution and Correction of Postural Asymmetries
An observational study of This Study Highlights Differences in Baropodometry Between Genders, run by University of Beira Interior at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 92 yearsHealthy volunteers can take part
- Conditions the study is for
- This Study Highlights Differences in Baropodometry Between Genders
- What is being tested?
- Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution
- How many people
- 52 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2023to 1 Feb 2024
- Phase
- Observational
- 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 92 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Svitlana Dikhtyarenko
Setúbal, Rua Das Areias, 11 - 2, 2910-407
About this study
Official title: 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.
Read the 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.
- Being tested
- Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution
- Keywords
- Baropodometry, Bioimpedance, Artificial Intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effectiveness of physical exercise in preventing pain and improving plantar pressure distributionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| I | The 'M' point is on the heels of both feet. Receives: Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution | |
| II | The 'M' point is located on the heel of the left foot and the forefoot of the right foot. Receives: Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution | |
| III | Point 'M' is located on the heel of the right foot and the forefoot of the left foot. Receives: Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution | |
| IV | The point of maximum pressure is in the forefoot area of both feet. Receives: Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution | |
| V | The 'M' point is in the medial zone on both feet. Receives: Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution | |
| VI | The 'M' point is located on the left midfoot and right rearfoot. Receives: Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution | |
| VII | The 'M' point is located on the right midfoot and left rearfoot. Receives: Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distribution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Importance and benefits of physical exercise in preventing pain and improving quality of life
Sequencing of the training plan
Measured: 12 weeks
Secondary outcomes (1)
Bodily pain and discomfort
Relationship between posture and pain
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Oct 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study Highlights Differences in Baropodometry Between GendersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Other
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beira Interior
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svitlana Dikhtyarenko, University of Beira Interior
- Investigators
- Pedro Mr Forte, PhD, Study director, University of Beira InteriorDulce Ms Esteves, PhD, Study director, University os Beira Interior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647355
- Sponsor's protocol ID
- CE-UBI-Pj-2023-030
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Body Pain by Postural Related Problems in Middle-age and Older Adults Using Machine Learning
- ClinicalTrials.gov ID
- NCT06647355
- Acronym / sponsor ID
- CE-UBI-Pj-2023-030
- Keywords
- Baropodometry, Bioimpedance, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Beira InteriorUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Other
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| I | – | Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distributionThe 'M' point is on the heels of both feet. |
| II | – | Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distributionThe 'M' point is located on the heel of the left foot and the forefoot of the right foot. |
| III | – | Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distributionPoint 'M' is located on the heel of the right foot and the forefoot of the left foot. |
| IV | – | Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distributionThe point of maximum pressure is in the forefoot area of both feet. |
| V | – | Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distributionThe 'M' point is in the medial zone on both feet. |
| VI | – | Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distributionThe 'M' point is located on the left midfoot and right rearfoot. |
| VII | – | Other: Effectiveness of physical exercise in preventing pain and improving plantar pressure distributionThe 'M' point is located on the right midfoot and left rearfoot. |
Who may qualify
- Ages
- 18 to 92 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effectiveness of physical exercise in preventing pain and improving plantar pressure distributionAt 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. | Other | I, II, III, IV, V, VI, VII |
Primary outcome
Importance and benefits of physical exercise in preventing pain and improving quality of life
Time frame: 12 weeks
Sequencing of the training plan
1 secondary outcome
Bodily pain and discomfort
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Mr Forte, PhD study director
University of Beira Interior
Dulce Ms Esteves, PhD study director
University os Beira Interior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of This Study Highlights Differences in Baropodometry Between Genders, run by University of Beira Interior at 1 site in Portugal.
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 1 inclusion and 1 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 17 Oct 2024. 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 Portugal. 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. 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?
Importance and benefits of physical exercise in preventing pain and improving quality of life (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2024.