Foot DiseasesNCT05197166
Baropodometric Assessment of the Podiatric Profile of Nursing Students in Clinical Settings
An observational study of Foot Diseases and Ankle Disorders Injuries, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
Trial summary
The nursing profession is highly affected by exhausting positions, namely prolonged standing and walking, which are the second work-related factor hindering foot health. In fact, the most common work-related disorders among nurses and nursing students are those related to lower limbs, particularly the foot and ankle. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Foot Diseases, Ankle Disorders Injuries
- What is being tested?
- Acute Clinical Settings
- How many people
- 200 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2022to 30 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nursing students (enrolled in a nursing bachelor of a Nursing School), in learning clinical settings (acute care),
Who may be able to join
- A nursing student enrolled in a learning acute clinical setting (e.g., hospitals).
- No diagnosed chronic systematic diseases (e.g., rheumatoid arthritis).
- No diagnosed metabolic disorders (e.g., diabetes).
- No visible lower limb swelling.
- No venous or lymphatic insufficiency.
- Voluntary written consent.
Who cannot join
- Presence of contraindications for baropodometric-related measurements;
- No consent to take part in the study.
- History of orthopaedic, neurological, and/or musculoskeletal problems likely to affect gait.
Trial locations and contacts
1 site in 1 country.
About this study
The nursing profession is highly affected by exhausting positions, namely prolonged standing and walking, which are the second work-related factor hindering foot health. In fact, the most common work-related disorders among nurses and nursing students are those related to lower limbs, particularly the foot and ankle. Such disorders, if not adequately prevented, contribute to the decrease in quality of life and high student drop-out rates.
To effectively develop preventive interventions among students, namely self-care actions, it's important to assess with detail the relationship and influence that clinical settings have on foot health. According to some authors, the biomechanics of many foot disorders are still poorly understood, and more studies are needed.
In this sense, the aim of this study is to understand the influence of prolonged standing and walking positions on nursing students' foot health. Moreover, what's the relationship between the podiatric profile (regional force and pressure exerted on the foot) and related signs and symptoms.
Read the detailed description
Work-related injuries, particularly musculoskeletal injuries, are usually an important cause of decreased quality of life and absenteeism from work, being very common in the nursing profession and also among students. Among the most common injuries are those related to the lower limbs, particularly feet and ankles, and the foot health of nurses is not satisfactory, with a great shortage of specific studies in this area and in this population.
Although several studies identify this problem, few describe in detail the causes of pain or discomfort. On the other hand, the podiatry evaluations are poor, which limits a more detailed knowledge of the phenomenon under study. Some solutions, namely the development of ergonomic footwear are insufficient and few interventions are adequate to improve the foot health of nursing students.
The present study aims to understand the influence of prolonged standing and walking positions on nursing students' foot health. Moreover, what's the relationship between the podiatric profile (regional force and pressure exerted on the foot) and related signs and symptoms.
The observational study will consist of two moments (before and after clinical setting periods), in which the participants (Nursing students) will complete a four-dimensional foot health self-assessment instrument (skin health, nail health, foot structure, pain). Additionally, the podiatric profile will be assessed through a force platform scan, which will score force and pressure values. Moreover, foot posture and foot function will be evaluated, through the modified arch index (MAI) and pressure excursion index (CPEI), respectively. Relevant variables will include spatio-temporal, kinematic, and kinetic data.
- Conditions
- Foot Diseases, Ankle Disorders Injuries
- Being tested
- Acute Clinical Settings
- Keywords
- foot disorders, ankle disorders, nursing, foot health, foot self-care
- Medical subject headings
- Foot Diseases, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Clinical SettingsOther
Acute clinical settings, like hospitals, where students are exposed to normal daily shift activities, involving prolonged walking and standing positions.
| Study group | Role | What they receive |
|---|---|---|
| Nursing students | Nursing students exposed to standing environments (prolonged walking and prolonged standing) during acute clinical settings (e.g., hospitals). Receives: Other: Acute Clinical Settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Podiatric Profile at 5 months
It relates to specific foot-related dynamic variables while standing or walking, illustrating the actual behaviour of the foot during activity. The podiatric profile is assessed through a pedography platform, which gives values of pressure (throughout time), exerted force, and contact areas of the foot.
Measured: Evaluated before (Month 0) and after (Month 5) the exposure (acute clinical settings).
Change in Foot Health at 5 months
Foot health relates to the observed clinical parameters, signs, and symptoms of this body part, namely skin, nails, and structure, and is evaluated through a subjective self-assessment Liker-type instrument with four dimensions related to general foot health.
Measured: Evaluated before (Month 0) and after (Month 5) the exposure (acute clinical settings).
Secondary outcomes (2)
Foot Self-Care Knowledge
Self-care knowledge is assessed through a four-dimensional questionnaire, where specific interventions for the promotion and prevention of foot and ankle disorders are evaluated.
Measured: During the exposure time; between Month 0 and Month 5.
Student's perceptions
Nursing student's perceptions on the influence of foot health in their quality of life during exposure time. It is evaluated through semi-structured interviews and focus groups.
Measured: After exposure time (Month 5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Jan 2022
- Primary completion26 Jul 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Foot DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Enfermagem de Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, Universidade Católica Portuguesa
- Responsible party
- Principal investigator, Rafael Alves Bernardes, Escola Superior de Enfermagem de Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197166
- Sponsor's protocol ID
- 151102
- Status last verified
- Sep 2023
- First submitted
- 15 Dec 2021
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Publications
Stolt M, Miikkola M, Suhonen R, Leino-Kilpi H. Nurses' Perceptions of Their Foot Health: Implications for Occupational Health Care. Workplace Health Saf. 2018 Mar;66(3):136-143. doi: 10.1177/2165079917727011. Epub 2017 Aug 31.
PubMed 28856977Stolt M, Katajisto J, Peltonen J, Suhonen R, Leino-Kilpi H. Development and testing of a new electronic foot health promotion programme on nurses' foot self-care. BMC Nurs. 2020 Apr 19;19:29. doi: 10.1186/s12912-020-00423-z. eCollection 2020.
PubMed 32327936Bakker EJM, Verhaegh KJ, Kox JHAM, van der Beek AJ, Boot CRL, Roelofs PDDM, Francke AL. Late dropout from nursing education: An interview study of nursing students' experiences and reasons. Nurse Educ Pract. 2019 Aug;39:17-25. doi: 10.1016/j.nepr.2019.07.005. Epub 2019 Jul 15.
PubMed 31352089Hagedorn TJ, Dufour AB, Riskowski JL, Hillstrom HJ, Menz HB, Casey VA, Hannan MT. Foot disorders, foot posture, and foot function: the Framingham foot study. PLoS One. 2013 Sep 5;8(9):e74364. doi: 10.1371/journal.pone.0074364. eCollection 2013.
PubMed 24040231Chiwaridzo M, Makotore V, Dambi JM, Munambah N, Mhlanga M. Work-related musculoskeletal disorders among registered general nurses: a case of a large central hospital in Harare, Zimbabwe. BMC Res Notes. 2018 May 18;11(1):315. doi: 10.1186/s13104-018-3412-8.
PubMed 29776452Stolt M, Suhonen R, Puukka P, Viitanen M, Voutilainen P, Leino-Kilpi H. Nurses' knowledge of foot care in the context of home care: a cross-sectional correlational survey study. J Clin Nurs. 2015 Oct;24(19-20):2916-25. doi: 10.1111/jocn.12922. Epub 2015 Jul 14.
PubMed 26179162Stolt M, Suhonen R, Kielo E, Katajisto J, Leino-Kilpi H. Foot health of nurses-A cross-sectional study. Int J Nurs Pract. 2017 Aug;23(4). doi: 10.1111/ijn.12560. Epub 2017 Jun 19.
PubMed 28631438Yan P, Li F, Zhang L, Yang Y, Huang A, Wang Y, Yao H. Prevalence of Work-Related Musculoskeletal Disorders in the Nurses Working in Hospitals of Xinjiang Uygur Autonomous Region. Pain Res Manag. 2017;2017:5757108. doi: 10.1155/2017/5757108. Epub 2017 Jul 13.
PubMed 28785160Richardson A, Gurung G, Derrett S, Harcombe H. Perspectives on preventing musculoskeletal injuries in nurses: A qualitative study. Nurs Open. 2019 Apr 13;6(3):915-929. doi: 10.1002/nop2.272. eCollection 2019 Jul.
PubMed 31367415Sanchez-Saez JM, Palomo-Lopez P, Becerro-de-Bengoa-Vallejo R, Calvo-Lobo C, Losa-Iglesias ME, Lopez-Del-Amo-Lorente A, Lopez-Lopez D. Stability of Three Different Sanitary Shoes on Healthcare Workers: A Cross-Sectional Study. Int J Environ Res Public Health. 2019 Jun 16;16(12):2126. doi: 10.3390/ijerph16122126.
PubMed 31208123Abledu JK, Offei EB. Musculoskeletal disorders among first-year Ghanaian students in a nursing college. Afr Health Sci. 2015 Jun;15(2):444-9. doi: 10.4314/ahs.v15i2.18.
PubMed 26124790Bernardes RA, Caldeira S, Parreira P, Sousa LB, Almeida IF, Santos-Costa P, Paiva-Santos F, Guardado Cruz A. Baropodometric Assessment of the Podiatric Profile of Nursing Students in Clinical Settings: A Study Protocol. Front Public Health. 2022 May 12;10:862048. doi: 10.3389/fpubh.2022.862048. eCollection 2022.
PubMed 35646767
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baropodometric Assessment of the Podiatric Profile of Nursing Students in Clinical Settings
- ClinicalTrials.gov ID
- NCT05197166
- Acronym / sponsor ID
- 151102
- Conditions
- Foot Diseases, Ankle Disorders Injuries
- Keywords
- foot disorders, ankle disorders, nursing, foot health, foot self-care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Escola Superior de Enfermagem de CoimbraUniversity, hospital or other
- Collaborators
- University of Turku, Universidade Católica Portuguesa
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 19 Jan 2022 (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 nursing profession is highly affected by exhausting positions, namely prolonged standing and walking, which are the second work-related factor hindering foot health. In fact, the most common work-related disorders among nurses and nursing students are those related to lower limbs, particularly the foot and ankle. Such disorders, if not adequately prevented, contribute to the decrease in quality of life and high student drop-out rates.
To effectively develop preventive interventions among students, namely self-care actions, it's important to assess with detail the relationship and influence that clinical settings have on foot health. According to some authors, the biomechanics of many foot disorders are still poorly understood, and more studies are needed.
In this sense, the aim of this study is to understand the influence of prolonged standing and walking positions on nursing students' foot health. Moreover, what's the relationship between the podiatric profile (regional force and pressure exerted on the foot) and related signs and symptoms.
Detailed description
Work-related injuries, particularly musculoskeletal injuries, are usually an important cause of decreased quality of life and absenteeism from work, being very common in the nursing profession and also among students. Among the most common injuries are those related to the lower limbs, particularly feet and ankles, and the foot health of nurses is not satisfactory, with a great shortage of specific studies in this area and in this population.
Although several studies identify this problem, few describe in detail the causes of pain or discomfort. On the other hand, the podiatry evaluations are poor, which limits a more detailed knowledge of the phenomenon under study. Some solutions, namely the development of ergonomic footwear are insufficient and few interventions are adequate to improve the foot health of nursing students.
The present study aims to understand the influence of prolonged standing and walking positions on nursing students' foot health. Moreover, what's the relationship between the podiatric profile (regional force and pressure exerted on the foot) and related signs and symptoms.
The observational study will consist of two moments (before and after clinical setting periods), in which the participants (Nursing students) will complete a four-dimensional foot health self-assessment instrument (skin health, nail health, foot structure, pain). Additionally, the podiatric profile will be assessed through a force platform scan, which will score force and pressure values. Moreover, foot posture and foot function will be evaluated, through the modified arch index (MAI) and pressure excursion index (CPEI), respectively. Relevant variables will include spatio-temporal, kinematic, and kinetic data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing students | – | Other: Acute Clinical SettingsNursing students exposed to standing environments (prolonged walking and prolonged standing) during acute clinical settings (e.g., hospitals). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nursing students (enrolled in a nursing bachelor of a Nursing School), in learning clinical settings (acute care),
Key inclusion criteria (6 listed)
- A nursing student enrolled in a learning acute clinical setting (e.g., hospitals).
- No diagnosed chronic systematic diseases (e.g., rheumatoid arthritis).
- No diagnosed metabolic disorders (e.g., diabetes).
- No visible lower limb swelling.
- No venous or lymphatic insufficiency.
Key exclusion criteria (3 listed)
- Presence of contraindications for baropodometric-related measurements;
- No consent to take part in the study.
- History of orthopaedic, neurological, and/or musculoskeletal problems likely to affect gait.
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 |
|---|---|---|
| Acute Clinical SettingsAcute clinical settings, like hospitals, where students are exposed to normal daily shift activities, involving prolonged walking and standing positions. | Other | Nursing students |
Primary outcome
Change in Podiatric Profile at 5 months
Time frame: Evaluated before (Month 0) and after (Month 5) the exposure (acute clinical settings).
It relates to specific foot-related dynamic variables while standing or walking, illustrating the actual behaviour of the foot during activity. The podiatric profile is assessed through a pedography platform, which gives values of pressure (throughout time), exerted force, and contact areas of the foot.
Change in Foot Health at 5 months
Time frame: Evaluated before (Month 0) and after (Month 5) the exposure (acute clinical settings).
Foot health relates to the observed clinical parameters, signs, and symptoms of this body part, namely skin, nails, and structure, and is evaluated through a subjective self-assessment Liker-type instrument with four dimensions related to general foot health.
2 secondary outcomes
Foot Self-Care Knowledge
Time frame: During the exposure time; between Month 0 and Month 5.
Student's perceptions
Time frame: After exposure time (Month 5).
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 14 Sep 2023.
- Background: PubMed 28856977Stolt M, Miikkola M, Suhonen R, Leino-Kilpi H. Nurses' Perceptions of Their Foot Health: Implications for Occupational Health Care. Workplace Health Saf. 2018 Mar;66(3):136-143. doi: 10.1177/2165079917727011. Epub 2017 Aug 31.
- Background: PubMed 32327936Stolt M, Katajisto J, Peltonen J, Suhonen R, Leino-Kilpi H. Development and testing of a new electronic foot health promotion programme on nurses' foot self-care. BMC Nurs. 2020 Apr 19;19:29. doi: 10.1186/s12912-020-00423-z. eCollection 2020.
- Background: PubMed 31352089Bakker EJM, Verhaegh KJ, Kox JHAM, van der Beek AJ, Boot CRL, Roelofs PDDM, Francke AL. Late dropout from nursing education: An interview study of nursing students' experiences and reasons. Nurse Educ Pract. 2019 Aug;39:17-25. doi: 10.1016/j.nepr.2019.07.005. Epub 2019 Jul 15.
- Background: PubMed 24040231Hagedorn TJ, Dufour AB, Riskowski JL, Hillstrom HJ, Menz HB, Casey VA, Hannan MT. Foot disorders, foot posture, and foot function: the Framingham foot study. PLoS One. 2013 Sep 5;8(9):e74364. doi: 10.1371/journal.pone.0074364. eCollection 2013.
- Background: PubMed 29776452Chiwaridzo M, Makotore V, Dambi JM, Munambah N, Mhlanga M. Work-related musculoskeletal disorders among registered general nurses: a case of a large central hospital in Harare, Zimbabwe. BMC Res Notes. 2018 May 18;11(1):315. doi: 10.1186/s13104-018-3412-8.
- Background: PubMed 26179162Stolt M, Suhonen R, Puukka P, Viitanen M, Voutilainen P, Leino-Kilpi H. Nurses' knowledge of foot care in the context of home care: a cross-sectional correlational survey study. J Clin Nurs. 2015 Oct;24(19-20):2916-25. doi: 10.1111/jocn.12922. Epub 2015 Jul 14.
- Background: PubMed 28631438Stolt M, Suhonen R, Kielo E, Katajisto J, Leino-Kilpi H. Foot health of nurses-A cross-sectional study. Int J Nurs Pract. 2017 Aug;23(4). doi: 10.1111/ijn.12560. Epub 2017 Jun 19.
- Background: PubMed 28785160Yan P, Li F, Zhang L, Yang Y, Huang A, Wang Y, Yao H. Prevalence of Work-Related Musculoskeletal Disorders in the Nurses Working in Hospitals of Xinjiang Uygur Autonomous Region. Pain Res Manag. 2017;2017:5757108. doi: 10.1155/2017/5757108. Epub 2017 Jul 13.
- Background: PubMed 31367415Richardson A, Gurung G, Derrett S, Harcombe H. Perspectives on preventing musculoskeletal injuries in nurses: A qualitative study. Nurs Open. 2019 Apr 13;6(3):915-929. doi: 10.1002/nop2.272. eCollection 2019 Jul.
- Background: PubMed 31208123Sanchez-Saez JM, Palomo-Lopez P, Becerro-de-Bengoa-Vallejo R, Calvo-Lobo C, Losa-Iglesias ME, Lopez-Del-Amo-Lorente A, Lopez-Lopez D. Stability of Three Different Sanitary Shoes on Healthcare Workers: A Cross-Sectional Study. Int J Environ Res Public Health. 2019 Jun 16;16(12):2126. doi: 10.3390/ijerph16122126.
- Background: PubMed 26124790Abledu JK, Offei EB. Musculoskeletal disorders among first-year Ghanaian students in a nursing college. Afr Health Sci. 2015 Jun;15(2):444-9. doi: 10.4314/ahs.v15i2.18.
- Derived from this study: PubMed 35646767Bernardes RA, Caldeira S, Parreira P, Sousa LB, Almeida IF, Santos-Costa P, Paiva-Santos F, Guardado Cruz A. Baropodometric Assessment of the Podiatric Profile of Nursing Students in Clinical Settings: A Study Protocol. Front Public Health. 2022 May 12;10:862048. doi: 10.3389/fpubh.2022.862048. eCollection 2022.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
Related trials for Foot Diseases
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Recruiting
Effectiveness of Pulsed Electromagnetic Field Therapy in Patients With Symptomatic Plantar Calcaneal Spurs
Calcaneal Spur
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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?
An observational study of Foot Diseases and Ankle Disorders Injuries, run by Escola Superior de Enfermagem de Coimbra 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 6 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 14 Sep 2023. 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?
Change in Podiatric Profile at 5 months (time frame: Evaluated before (Month 0) and after (Month 5) the exposure (acute clinical settings).). The study lists 2 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 NCT05197166, which also lists 12 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 14 Sep 2023.