ObesityNCT03441763
Shifting and Distribution of Foot Pressure Among Obese Subjects
A study testing Emed foot device in people with Obesity, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
Background: The foot is considered a sensitive structure of musculoskeletal system that bears significant loads of the body weight during walking. So, the evaluation of the body weights on planter pressure distribution during walking among adult obese subjects is very critical for foot dysfunctions.The aims:To… Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Emed foot device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Apr 2017to 30 May 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who are normal or over weight or obese . Subjects who are free from any musculoskeletal abnormalities .
Who cannot join
- Subjects has any foot deformity, flat foot, acute lower extremity trauma, lower extremity surgery like prosthesis operations of the hip, knee, ankle or foot, Subjects has problems of cooperation including; eye, ear oar cognitive disorders, diabetes or related peripheral neuropathy, vascular insufficiency, walking aids .
- Subjects has age greater than 40 or less than 25 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Body Weight on Shifting of Foot Pressure Among Obese Subjects
Background: The foot is considered a sensitive structure of musculoskeletal system that bears significant loads of the body weight during walking. So, the evaluation of the body weights on planter pressure distribution during walking among adult obese subjects is very critical for foot dysfunctions.The aims:To evaluate the planter pressure distribution in normal ,over weight and obese adult during dynamic situation. Subjects and Methods: A one-hundred fifty normal adult (male and female) subjects will be recruited in this study. They will be divided into Group-I: includes 50 normal subjects Group-II: includes 50 of over weight subjects.group-III 50 obese adult subjects The all three groups will be detected according to the individual BMI. The details of the study will be explained to each participant and a consent form was signed by each subject.Each participant should be free from any musculoskeletal or locomotors disorders Conclusion: Results of this study can help physical therapists to understand the foot pressure distribution map for normal , over weight and obese and non-obese subjects to detect any foot abnormalities and detect any causes of foot dysfunctions.
Read the detailed description
A one hundred fifty volunteers (male and female), age from 20 to 40 years old subjects will be recruited in this study. Demographic data of all participating subjects like age, weight, height, feet size, and body mass index (BMI) will be assessed. All participants will be assigned to three groups per measurement of individual BMI: Group-I: includes 50 normal subjects (18.5 -24.9 BMI); Group-II: includes50 overweight subjects (25.0 -29.9 BMI); Group-III: includes 50 obese subjects (30.0 and Above BMI) (Nuttall, 2015). The procedure and purpose of the study will be explained in details for all participants. A consent form will be signed by each participant. Human research already approved by Institutional review board of Imam Abdulrahman Bin Faisal University(University of dammam previously ).IRB.2017- 03-065.
- Conditions
- Obesity
- Being tested
- Emed foot device
- Keywords
- Foot pressure, Obese, and normal Subjects
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emed foot deviceDevice
foot pressure will be measure by using emed foot pressure system
| Study group | Role | What they receive |
|---|---|---|
| Normal participants | Experimental | Emed foot device 3 times/measure to determine foot pressure in normal participants. . Receives: Device: Emed foot device |
| Over weight participants | Experimental | Emed foot device 3 times/measure to determine foot pressure in over weight participants. Receives: Device: Emed foot device |
| Obese participants | Experimental | Emed foot device 3 times/measure foot pressure in obese participants. Receives: Device: Emed foot device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot planter pressure
Foot plantar pressure during walking will be detected in four anatomical foot areas (hindfoot, midfoot, forfoot, toes) for 150 normal and obese person using Emed pressure system
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start15 Apr 2017
- Primary completion15 Mar 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alsayed Abd Elhameed Shanb, Imam Abdulrahman Bin Faisal University
- Investigators
- Alsayed A Shanb, PhD, Principal investigator, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441763
- Sponsor's protocol ID
- 2017-03-065
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2017
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The final results only will be shared
Publications
Stess RM, Jensen SR, Mirmiran R. The role of dynamic plantar pressures in diabetic foot ulcers. Diabetes Care. 1997 May;20(5):855-8. doi: 10.2337/diacare.20.5.855.
PubMed 9135955
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Body Weight on Shifting of Foot Pressure Among Obese Subjects
- ClinicalTrials.gov ID
- NCT03441763
- Acronym / sponsor ID
- 2017-03-065
- Conditions
- Obesity
- Keywords
- Foot pressure, Obese, and normal Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 22 Feb 2018 (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: The foot is considered a sensitive structure of musculoskeletal system that bears significant loads of the body weight during walking. So, the evaluation of the body weights on planter pressure distribution during walking among adult obese subjects is very critical for foot dysfunctions.The aims:To evaluate the planter pressure distribution in normal ,over weight and obese adult during dynamic situation. Subjects and Methods: A one-hundred fifty normal adult (male and female) subjects will be recruited in this study. They will be divided into Group-I: includes 50 normal subjects Group-II: includes 50 of over weight subjects.group-III 50 obese adult subjects The all three groups will be detected according to the individual BMI. The details of the study will be explained to each participant and a consent form was signed by each subject.Each participant should be free from any musculoskeletal or locomotors disorders Conclusion: Results of this study can help physical therapists to understand the foot pressure distribution map for normal , over weight and obese and non-obese subjects to detect any foot abnormalities and detect any causes of foot dysfunctions.
Detailed description
A one hundred fifty volunteers (male and female), age from 20 to 40 years old subjects will be recruited in this study. Demographic data of all participating subjects like age, weight, height, feet size, and body mass index (BMI) will be assessed. All participants will be assigned to three groups per measurement of individual BMI: Group-I: includes 50 normal subjects (18.5 -24.9 BMI); Group-II: includes50 overweight subjects (25.0 -29.9 BMI); Group-III: includes 50 obese subjects (30.0 and Above BMI) (Nuttall, 2015). The procedure and purpose of the study will be explained in details for all participants. A consent form will be signed by each participant. Human research already approved by Institutional review board of Imam Abdulrahman Bin Faisal University(University of dammam previously ).IRB.2017- 03-065.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal participants | Experimental | Device: Emed foot deviceEmed foot device 3 times/measure to determine foot pressure in normal participants. . |
| Over weight participants | Experimental | Device: Emed foot deviceEmed foot device 3 times/measure to determine foot pressure in over weight participants. |
| Obese participants | Experimental | Device: Emed foot deviceEmed foot device 3 times/measure foot pressure in obese participants. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects who are normal or over weight or obese . Subjects who are free from any musculoskeletal abnormalities .
Key exclusion criteria (2 listed)
- Subjects has any foot deformity, flat foot, acute lower extremity trauma, lower extremity surgery like prosthesis operations of the hip, knee, ankle or foot, Subjects has problems of cooperation including; eye, ear oar cognitive disorders, diabetes or related peripheral neuropathy, vascular insufficiency, walking aids .
- Subjects has age greater than 40 or less than 25 years.
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 |
|---|---|---|
| Emed foot devicefoot pressure will be measure by using emed foot pressure system | Device | Normal participants, Obese participants, Over weight participants |
Primary outcome
Foot planter pressure
Time frame: 3 months
Foot plantar pressure during walking will be detected in four anatomical foot areas (hindfoot, midfoot, forfoot, toes) for 150 normal and obese person using Emed pressure system
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 7 Apr 2020.
- Background: PubMed 9135955Stess RM, Jensen SR, Mirmiran R. The role of dynamic plantar pressures in diabetic foot ulcers. Diabetes Care. 1997 May;20(5):855-8. doi: 10.2337/diacare.20.5.855.
- doi: 10.1016/j.gaitpost.2008.01.012. Epub 2008 MLink provided by the sponsor.
- Individual participant dataSharing planned: No. The final results only will be shared
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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.
Alsayed A Shanb, PhD principal investigator
Imam Abdulrahman Bin Faisal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emed foot device in people with Obesity, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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 2 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 7 Apr 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 Saudi Arabia. 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?
Foot planter pressure (time frame: 3 months). 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 NCT03441763, which also lists 1 linked publication.
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 7 Apr 2020.