Postural ImbalanceNCT04809441
Baropodometric Parameters Variation With Body Weight Loss
A study testing Diet change in people with Postural Imbalance and Obesity, run by Fundacion Podoactiva at 1 site in Spain.
Trial summary
Background: One of the major public health problems of the 21st century is obesity. Baropodometry is commonly used to determine specific loads on the plantar surface of the foot and the comportment of the body center of pressure (CoP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postural Imbalance, Obesity
- What is being tested?
- Diet change
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2019to 14 Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight subjects
- between 18 and 65 years old
- medical weight loss indicated
- no lower limb or spine pathology that might affect normal gait, nor structural or functional deformities in the feet.
Who cannot join
- not comply inclusion criteria
- reported pain in their feet within the previous 6 months
- had any previous foot surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Baropodometric Parameters Variation With Body Weight Loss: a Prospective Cohort Study
Background: One of the major public health problems of the 21st century is obesity. Baropodometry is commonly used to determine specific loads on the plantar surface of the foot and the comportment of the body center of pressure (CoP). To evaluate the redistribution of the baropodometric parameters: static and dynamic plantar pressures and antero - posterior CoP, by decreasing body weight.
Methods: A sample of 43 overweight subjects (24 male, 19 female) would be recruited for the study. A hypocaloric diet would be designed with the aim to reduce participants body weight. The baropodometric exam would performed in two occasions: weight 1 - Session 1 and weight 2 - Session 2, when participants lost between 12 and 18 kg. The foot would be divided in 9 areas: heel, midfoot, 5 metatarsal heads (MTHs), Hallux, 2-5 toes. The Footwork® pressure platform would be used to carry out the evaluation.
Read the detailed description
Scientific Background Obesity is in one of the major public health problems of the 21st century and its prevalence has tripled in many European countries in the last decades. It is a strongly problem associated with a lower quality of life, as well as with the development of serious chronic metabolic, cardiac and circulatory pathologies and musculoskeletal disorders. Quantitative data showed that excessive body weight negatively effects on standing and walking.
Plantar pressure measurement is commonly used to determine specific loads on the plantar surface of the foot. There are many case studies that assess pressures of the normal foot and try to establish patterns of pathological pressures. The CoP represents the average of all the weight that is in contact with the surface of the floor and is expressed as the point where the vector of the vertical reaction forces of the soil is located.
In the literature it can be found how body weight influences on plantar pressure data and on the position of the CoP. Excesses of body weight has shown to have negative structural consequences in the feet and lower limbs. Obesity is also related with an anterior displacement of the CoP, since the instability in obese people, associated to weight increasing, seems to be determinant with CoP in an anterior position.
Computerized baropodometry is helpful for foot diseases diagnosis, foot function evaluation and to follow-up the treatment. It has been practiced to determine specific weight parameters in obese adults, among others. Nonetheless, there are not in the literature specific studies that have analyzed by computerized baropodometry how plantar pressures and CoP improve by decreasing body weight in obese adults.
Objective The present research wanted to evaluate plantar pressures and antero - posterior CoP improvement by decreasing body weight in static and dynamic baropodometry data collection in obese adults.
Design The design of the present research was based on and executed according to the STROBE reporting guideline. The study was approved by the Ethics Committee of Clinical Research of Aragón (CEICA) with number C.P.-C.I. PI17/0203. Participants voluntarily signed an informed consent. The study has been conducted in accordance with the Helsinki Principles.
Participants The study would include overweight subjects between 18 and 65 years old, medical weight loss indicated, no lower limb or spine pathology that might affect normal gait, nor structural or functional deformities in the feet. Candidates who not comply inclusion criteria, or reported pain in participant´s feet within the previous 6 months, or had any previous foot surgery would be excluded. Them would be recruited at one Endocrinology and Nutrition private clinic in Huesca, Spain.
Procedure Participants would be rigorously evaluated by the same endocrine doctor and podiatrist at baseline (Session 1) and at the end of the study after weight loss intervention (Session 2), when each participant lost between 11-12% of its corporal weight. Therefore, there will be obtained 2 weight related with the two sessions: Session 1 - Weight 1; Session 2 - Weight 2.
In order to achieve the propose weight loss, lifestyle modification would be applied: A specific very low-calorie diet (<800kcal/day), and 2 daily sessions of 15 minutes of anaerobic physical exercise depending on the capacity of the participants.
At Session 1 and Session 2, before and after weight loss intervention, participants would be subjected to a baropodometric examination (static and dynamic). It allows to quantitatively mapping pressures in each segment of the plantar surface. For the static, participants would be asked to stand in the center of the platform for 5 seconds, with their arms on either side of the body in a natural position looking straight ahead. To minimize individual´s corporal fluctuations in static (as body weight oscillation and imbalance) the procedure would be applied 3 times per session. For the dynamic, participants would be asked to walk barefoot on the platform at their normal pace following the 3-step protocol, which requires landing on the platform on the third step of gait. To minimize corporal individual fluctuations in dynamic (as body weight oscillation, imbalance and changes in gait speed) the procedure would be applied 3 times per session. Both feet would be subdivided into 9 areas: heel, midfoot, 5 MTHs, the Hallux, 2-5 toes.
Peak pressures of these areas in kg/cm2 and the position of the CoP, were obtained using the Footwork® software. Peak pressure data were graphically exposed and related with the two weights for each patient.
Equipment Participant´s weight and height were measured during each session with an Año-Sayol scale and stadiometer, respectively (Año-Sayol SL, Barcelona, Spain).
Footwork® platform (AM3-IST®, France), was used for the baropodometric analysis.
Statistical Analysis An initial exploratory analysis of all clinical variables would be carried out. Continuous variables would be expressed as mean ± standard deviation (SD), whereas qualitative variables would be expressed as frequencies and percentages. Continuous data would be checked for normality by Kolmogorov-Smirnov Test. Chi-Square Test would be applied to show the relationship between qualitative variables. To compare mean weights between two independent groups according to normality, Student's-T Test and ANOVA Test to "m" groups would be used. Differences between Session 1 and Session 2, would be performed using mean comparison methods, Wilcoxon when the variable does not follow normal distribution, and Student's T for related samples when there is normality. To quantify the difference between weight and plantar pressures and the CoP at Session 1 and Session 2 the "change percentage" would be calculated, which would be defined as the relative variation in percentage points between both sessions: Weight-Change % (WC%)= [(Weight at Session 2 - Weight at Session 1)/ Weight Session 1] x 100; Plantar-Pressure-Change % (PPC%) = [(Pressure at Session 2 - Pressure at Session 1)/ Pressure at Session 1] x 100; CoP-Change % = [(time CoP X+1 - time CoP X)/ time CoP X] x 100. The "change percentage" would be analyzed through Spearman correlation coefficient, according to normality.
The "improve" variable would be established in order to analyze the possible relationship between weight loss and the 9 pressure foot areas considered at Session 1 and Session 2 for both: static and dynamic baropodometry. Statistical significance level would be set at p <0.05, confidence level set in the comparisons was 95%. The statistical analyses would be performed using the SPSS software 22.0 for Windows (SPSS Ibérica, Madrid, Spain).
- Conditions
- Postural Imbalance, Obesity
- Being tested
- Diet change
- Keywords
- Pressure, Static posture, Dynamic
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet changeOther
A specific very low-calorie diet (<800kcal/day), and 2 daily sessions of 15 minutes of anaerobic physical exercise depending on the capacity of the participants, were designed
| Study group | Role | What they receive |
|---|---|---|
| Weight loss group | Experimental | Participants were rigorously evaluated by the same endocrine doctor and podiatrist at baseline (Session 1) and at the end of the study after weight loss intervention (Session 2), when each participant had lost between 11-12% of its corporal weight. Therefore, we obtained 2 weight related with the two sessions: Session 1 - Weight 1; Session 2 - Weight 2. Receives: Other: Diet change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Weight change would be measured at baseline (Session 1) and at the end of the study after weight loss intervention (Session 2), when each participant lost between 11-12 percent of its corporal weight. Therefore, we will obtain 2 weight related with the two sessions: Session 1 - Weight 1; Session 2 - Weight 2.
Measured: baseline, before procedure and immediately after the procedure
Static pressure change
For the static pressure, participants would be asked to stand in the center of the plantar pressure platform for 5 seconds, with their arms on either side of the body in a natural position looking straight ahead. Both feet would be subdivided into 9 pressure areas: heel, midfoot, 5 MTHs, the Hallux, 2-5 toes. Whre maximun and mean static pressures would be measured.
Measured: baseline, before procedure and immediately after the procedure
Dynamic pressure change
For the dinamic pressure, participants would be asked to walk throught the plantar pressure platform at they preferred speed. Both feet would be subdivided into 9 pressure areas: heel, midfoot, 5 MTHs, the Hallux, 2-5 toes. Whre maximun and mean dynamic pressures would be measured.
Measured: baseline, before procedure and immediately after the procedure
Cop change
Displacement from Session 1 to Session 2 position of the Center of pressures obteined with the pressure platform
Measured: baseline, before procedure and immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start10 Jun 2019
- Primary completion10 Nov 2019
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural ImbalanceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Podoactiva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809441
- Sponsor's protocol ID
- Podo-C.P.-C.I.PI17/020
- Status last verified
- Mar 2021
- First submitted
- 25 Nov 2020
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baropodometric Parameters Variation With Body Weight Loss: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04809441
- Acronym / sponsor ID
- Podo-C.P.-C.I.PI17/020
- Conditions
- Postural Imbalance, Obesity
- Keywords
- Pressure, Static posture, Dynamic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fundacion PodoactivaUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 22 Mar 2021 (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.
Background: One of the major public health problems of the 21st century is obesity. Baropodometry is commonly used to determine specific loads on the plantar surface of the foot and the comportment of the body center of pressure (CoP). To evaluate the redistribution of the baropodometric parameters: static and dynamic plantar pressures and antero - posterior CoP, by decreasing body weight.
Methods: A sample of 43 overweight subjects (24 male, 19 female) would be recruited for the study. A hypocaloric diet would be designed with the aim to reduce participants body weight. The baropodometric exam would performed in two occasions: weight 1 - Session 1 and weight 2 - Session 2, when participants lost between 12 and 18 kg. The foot would be divided in 9 areas: heel, midfoot, 5 metatarsal heads (MTHs), Hallux, 2-5 toes. The Footwork® pressure platform would be used to carry out the evaluation.
Detailed description
Scientific Background Obesity is in one of the major public health problems of the 21st century and its prevalence has tripled in many European countries in the last decades. It is a strongly problem associated with a lower quality of life, as well as with the development of serious chronic metabolic, cardiac and circulatory pathologies and musculoskeletal disorders. Quantitative data showed that excessive body weight negatively effects on standing and walking.
Plantar pressure measurement is commonly used to determine specific loads on the plantar surface of the foot. There are many case studies that assess pressures of the normal foot and try to establish patterns of pathological pressures. The CoP represents the average of all the weight that is in contact with the surface of the floor and is expressed as the point where the vector of the vertical reaction forces of the soil is located.
In the literature it can be found how body weight influences on plantar pressure data and on the position of the CoP. Excesses of body weight has shown to have negative structural consequences in the feet and lower limbs. Obesity is also related with an anterior displacement of the CoP, since the instability in obese people, associated to weight increasing, seems to be determinant with CoP in an anterior position.
Computerized baropodometry is helpful for foot diseases diagnosis, foot function evaluation and to follow-up the treatment. It has been practiced to determine specific weight parameters in obese adults, among others. Nonetheless, there are not in the literature specific studies that have analyzed by computerized baropodometry how plantar pressures and CoP improve by decreasing body weight in obese adults.
Objective The present research wanted to evaluate plantar pressures and antero - posterior CoP improvement by decreasing body weight in static and dynamic baropodometry data collection in obese adults.
Design The design of the present research was based on and executed according to the STROBE reporting guideline. The study was approved by the Ethics Committee of Clinical Research of Aragón (CEICA) with number C.P.-C.I. PI17/0203. Participants voluntarily signed an informed consent. The study has been conducted in accordance with the Helsinki Principles.
Participants The study would include overweight subjects between 18 and 65 years old, medical weight loss indicated, no lower limb or spine pathology that might affect normal gait, nor structural or functional deformities in the feet. Candidates who not comply inclusion criteria, or reported pain in participant´s feet within the previous 6 months, or had any previous foot surgery would be excluded. Them would be recruited at one Endocrinology and Nutrition private clinic in Huesca, Spain.
Procedure Participants would be rigorously evaluated by the same endocrine doctor and podiatrist at baseline (Session 1) and at the end of the study after weight loss intervention (Session 2), when each participant lost between 11-12% of its corporal weight. Therefore, there will be obtained 2 weight related with the two sessions: Session 1 - Weight 1; Session 2 - Weight 2.
In order to achieve the propose weight loss, lifestyle modification would be applied: A specific very low-calorie diet (<800kcal/day), and 2 daily sessions of 15 minutes of anaerobic physical exercise depending on the capacity of the participants.
At Session 1 and Session 2, before and after weight loss intervention, participants would be subjected to a baropodometric examination (static and dynamic). It allows to quantitatively mapping pressures in each segment of the plantar surface. For the static, participants would be asked to stand in the center of the platform for 5 seconds, with their arms on either side of the body in a natural position looking straight ahead. To minimize individual´s corporal fluctuations in static (as body weight oscillation and imbalance) the procedure would be applied 3 times per session. For the dynamic, participants would be asked to walk barefoot on the platform at their normal pace following the 3-step protocol, which requires landing on the platform on the third step of gait. To minimize corporal individual fluctuations in dynamic (as body weight oscillation, imbalance and changes in gait speed) the procedure would be applied 3 times per session. Both feet would be subdivided into 9 areas: heel, midfoot, 5 MTHs, the Hallux, 2-5 toes.
Peak pressures of these areas in kg/cm2 and the position of the CoP, were obtained using the Footwork® software. Peak pressure data were graphically exposed and related with the two weights for each patient.
Equipment Participant´s weight and height were measured during each session with an Año-Sayol scale and stadiometer, respectively (Año-Sayol SL, Barcelona, Spain).
Footwork® platform (AM3-IST®, France), was used for the baropodometric analysis.
Statistical Analysis An initial exploratory analysis of all clinical variables would be carried out. Continuous variables would be expressed as mean ± standard deviation (SD), whereas qualitative variables would be expressed as frequencies and percentages. Continuous data would be checked for normality by Kolmogorov-Smirnov Test. Chi-Square Test would be applied to show the relationship between qualitative variables. To compare mean weights between two independent groups according to normality, Student's-T Test and ANOVA Test to "m" groups would be used. Differences between Session 1 and Session 2, would be performed using mean comparison methods, Wilcoxon when the variable does not follow normal distribution, and Student's T for related samples when there is normality. To quantify the difference between weight and plantar pressures and the CoP at Session 1 and Session 2 the "change percentage" would be calculated, which would be defined as the relative variation in percentage points between both sessions: Weight-Change % (WC%)= [(Weight at Session 2 - Weight at Session 1)/ Weight Session 1] x 100; Plantar-Pressure-Change % (PPC%) = [(Pressure at Session 2 - Pressure at Session 1)/ Pressure at Session 1] x 100; CoP-Change % = [(time CoP X+1 - time CoP X)/ time CoP X] x 100. The "change percentage" would be analyzed through Spearman correlation coefficient, according to normality.
The "improve" variable would be established in order to analyze the possible relationship between weight loss and the 9 pressure foot areas considered at Session 1 and Session 2 for both: static and dynamic baropodometry. Statistical significance level would be set at p <0.05, confidence level set in the comparisons was 95%. The statistical analyses would be performed using the SPSS software 22.0 for Windows (SPSS Ibérica, Madrid, Spain).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight loss group | Experimental | Other: Diet changeParticipants were rigorously evaluated by the same endocrine doctor and podiatrist at baseline (Session 1) and at the end of the study after weight loss intervention (Session 2), when each participant had lost between 11-12% of its corporal weight. Therefore, we obtained 2 weight related with the two sessions: Session 1 - Weight 1; Session 2 - Weight 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overweight subjects
- between 18 and 65 years old
- medical weight loss indicated
- no lower limb or spine pathology that might affect normal gait, nor structural or functional deformities in the feet.
Key exclusion criteria (3 listed)
- not comply inclusion criteria
- reported pain in their feet within the previous 6 months
- had any previous foot surgery
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 |
|---|---|---|
| Diet changeA specific very low-calorie diet (<800kcal/day), and 2 daily sessions of 15 minutes of anaerobic physical exercise depending on the capacity of the participants, were designed | Other | Weight loss group |
Primary outcome
Weight change
Time frame: baseline, before procedure and immediately after the procedure
Weight change would be measured at baseline (Session 1) and at the end of the study after weight loss intervention (Session 2), when each participant lost between 11-12 percent of its corporal weight. Therefore, we will obtain 2 weight related with the two sessions: Session 1 - Weight 1; Session 2 - Weight 2.
Static pressure change
Time frame: baseline, before procedure and immediately after the procedure
For the static pressure, participants would be asked to stand in the center of the plantar pressure platform for 5 seconds, with their arms on either side of the body in a natural position looking straight ahead. Both feet would be subdivided into 9 pressure areas: heel, midfoot, 5 MTHs, the Hallux, 2-5 toes. Whre maximun and mean static pressures would be measured.
Dynamic pressure change
Time frame: baseline, before procedure and immediately after the procedure
For the dinamic pressure, participants would be asked to walk throught the plantar pressure platform at they preferred speed. Both feet would be subdivided into 9 pressure areas: heel, midfoot, 5 MTHs, the Hallux, 2-5 toes. Whre maximun and mean dynamic pressures would be measured.
Cop change
Time frame: baseline, before procedure and immediately after the procedure
Displacement from Session 1 to Session 2 position of the Center of pressures obteined with the pressure platform
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 22 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet change in people with Postural Imbalance and Obesity, run by Fundacion Podoactiva 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 4 inclusion and 3 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 22 Mar 2021. 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. 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?
Weight change (time frame: baseline, before procedure and immediately after the procedure). The study lists 4 primary outcomes in all. 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 22 Mar 2021.