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Orthotic and Prosthetic RehabilitationNCT07734402

Prosthetics-Orthotics Rehabilitation Awareness

An observational study of Orthotic and Prosthetic Rehabilitation, run by Lokman Hekim University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Orthotic and prosthetic devices are essential rehabilitation tools for individuals with functional limitations resulting from amputation, musculoskeletal pathologies, neurological disorders, and congenital anomalies. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Orthotic and Prosthetic Rehabilitation
What is being tested?
Administration of the Prosthetics and Orthotics Awareness Questionnaire
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2026to 10 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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: The study population consists of third- and fourth-year students enrolled in the undergraduate Physiotherapy and Rehabilitation program at Lokman Hekim University, Faculty of Health Sciences, who have completed theoretical coursework related to orthotic and prosthetic rehabilitation. A total of 133 students (68 third-year and 65 fourth-year) participated in the study.

Who may be able to join

  • Aged 18 years or older
  • Actively enrolled as a student in the 3rd or 4th year of the undergraduate Physiotherapy and Rehabilitation program at Lokman Hekim University
  • Capable of completing the data collection tools fully and comprehensibly
  • Voluntarily agrees to participate in the study and approves the informed consent form
  • Has completed coursework related to orthotic and prosthetic rehabilitation

Who cannot join

  • Students with auditory, visual, or sensory impairments to a degree that could affect the study assessments
  • Students who complete the data collection tools incompletely or incorrectly
  • Students who are unable to read and understand Turkish

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Demet Öztürk, Assistant Professor contact

+90 506 839 42 88

demet.ozturk@lokmanhekim.edu.tr

Dilem Can, Master's Student contact

+90 507 582 93 79

251748007@lokmanhekim.edu.tr

Turkey (Türkiye)1 site
  • Lokman Hekim Univericity

    Ankara

    Demet Öztürk, Assistant Professor, +90 506 839 42 88, demet.ozturk@lokmanhekim.edu.tr

    Dilem Can, Master's Student, +90 507 582 93 79, 251748007@lokmanhekim.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: Examination of Prosthetics and Orthotics Rehabilitation Awareness Among Physiotherapy and Rehabilitation Students

Orthotic and prosthetic devices are essential rehabilitation tools for individuals with functional limitations resulting from amputation, musculoskeletal pathologies, neurological disorders, and congenital anomalies. Physiotherapists play a central role in orthotic and prosthetic rehabilitation, including need assessment, device selection, functional evaluation, patient education, and long-term follow-up. However, limited research has examined the knowledge, self-efficacy, and attitudes of physiotherapy students regarding this field during undergraduate education.

This descriptive, cross-sectional study aims to evaluate the knowledge, self-efficacy perception, and attitudes of undergraduate Physiotherapy and Rehabilitation students regarding orthotic and prosthetic rehabilitation. The study population consists of third- and fourth-year students enrolled in the Physiotherapy and Rehabilitation program at Lokman Hekim University, Faculty of Health Sciences, who have completed coursework related to orthotic and prosthetic rehabilitation and voluntarily agree to participate.

Read more

Data will be collected online via Google Forms using two tools: a demographic information form (age, gender, class level, grade point average, theoretical coursework, and clinical internship experience) and the Orthotics and Prosthetics Awareness Questionnaire. This 32-item questionnaire, developed by the investigators based on relevant literature and finalized through expert consultation using the Delphi technique, covers three subdimensions: Knowledge (11 items), Self-Efficacy (9 items), and Attitude (12 items), rated on a 5-point Likert scale.

The study will also examine whether knowledge, self-efficacy, and attitude scores differ according to class level, clinical experience (observation of devices and patients, level of participation in application processes), and academic performance. The findings are expected to contribute to the development of physiotherapy and rehabilitation curricula, strengthen interprofessional collaboration between physiotherapists and orthotist-prosthetists, and support the improvement of rehabilitation service quality in this field.

Read the detailed description

Orthotic and prosthetic devices are essential rehabilitation tools that facilitate the participation of individuals experiencing functional limitations-due to various health issues such as amputation, musculoskeletal pathologies, neurological disorders, and congenital anomalies-in daily social life, while enhancing their quality of life and supporting their overall well-being. In recent years, rapid advances in the fields of biomedical engineering, materials science, and digital health technologies have enabled these devices to be designed in an increasingly durable, lightweight, and functionally superior manner. However, technological development alone is insufficient, and optimal outcomes can only be achieved through a personalized rehabilitation approach based on interdisciplinary collaboration.

Physiotherapists are among the important members of the rehabilitation team in this process, with core competencies such as ambulation assessment, functional rehabilitation planning, and orthosis/prosthesis design and rehabilitation, and they work in direct collaboration with orthotist-prosthetists. In orthotic rehabilitation, the core responsibilities of the physiotherapist include increasing range of motion, reducing pain, developing muscle strength, improving muscle function, enhancing independence, preventing possible complications through early detection, and improving quality of life. Physiotherapists also play an important role in educating patients and their relatives on device use, integrating the orthosis into activities of daily living, and managing long-term follow-up. Their responsibilities in the orthotic rehabilitation process include determining the need for an orthosis, selecting the device appropriate to the individual and the condition, evaluating its effect on functionality, teaching donning/doffing and other usage features, monitoring device-related complications, and planning the exercise and rehabilitation process.

In prosthetic rehabilitation, the contribution of physiotherapists begins in the pre-amputation period, including preparing the individual for amputation surgery, strengthening exercises, and pre-prosthetic preparation programs. In the post-amputation period, physiotherapists are actively involved in prosthesis selection, ensuring prosthesis fit, gait training, balance and coordination exercises, and adaptation to different suspension systems. Facilitating individuals' return to daily life, social environments, and school/occupation is also among the core goals of physiotherapists in prosthetic rehabilitation.

Despite these critical roles, research on professional knowledge and awareness in this field remains limited. A cross-sectional study conducted among students in orthotics and prosthetics departments in Turkey found that participants correctly answered only about one-third of the questions in a professional awareness questionnaire, clearly demonstrating the need for educational interventions aimed at increasing awareness. Considering that the professional knowledge, self-efficacy perception, and attitudes that students acquire during their undergraduate education directly shape their post-graduation clinical practices and their functioning within the rehabilitation team, determining these variables at an early stage is of great importance for effectively guiding educational programs. Systematic reviews in the field of orthotic and prosthetic education indicate that research on this subject remains limited, and studies from the perspective of undergraduate education are particularly insufficient. Furthermore, no study has been found in the existing literature that jointly addresses the knowledge levels, self-efficacy perceptions, and attitudes of physiotherapy and rehabilitation students specific to the field of orthotics-prosthetics. This gap is considered notable given the critical role this professional group undertakes in the rehabilitation process.

Objectives: The main purpose of this study is to determine the knowledge levels, self-efficacy perceptions, and attitudes of students enrolled in the undergraduate Physiotherapy and Rehabilitation program regarding orthotic and prosthetic rehabilitation. The secondary purpose is to examine whether these variables differ according to class level, clinical experience, and demographic/academic characteristics. The findings are expected to contribute to the development of physiotherapy and rehabilitation education programs, strengthen interprofessional collaboration, and improve the quality of rehabilitation services.

Study Design: This study was designed as a descriptive, cross-sectional study. Study Population and Setting: The study population consists of third- and fourth-year students enrolled in the Physiotherapy and Rehabilitation undergraduate program at Lokman Hekim University, Faculty of Health Sciences. Students who were actively enrolled in the program, had taken courses related to orthotic and prosthetic rehabilitation, and voluntarily agreed to participate were included. Students with auditory, visual, or sensory impairments to a degree that could affect the study, as well as those who completed the data collection tools incompletely or incorrectly, were excluded.

Data Collection Tools: Two data collection tools were used. The first is a demographic information form prepared by the investigators, including participants' age, gender, class level, grade point average (GPA), status of having taken theoretical courses on orthotic and prosthetic rehabilitation, and clinical internship experience. The second is the Orthotics and Prosthetics Awareness Questionnaire, developed by the investigators based on the relevant literature. This questionnaire consists of a total of 32 items across three subdimensions: Knowledge (11 items), Self-Efficacy (9 items), and Attitude (12 items). Each item is rated on a 5-point Likert-type scale, where 1 indicates "Strongly Disagree" and 5 indicates "Strongly Agree." Prior to data collection, the questionnaire was developed using the Delphi technique, based on the opinions of experts (n=10) with at least 5 years of experience in orthotics-prosthetics and physiotherapy and rehabilitation; the questionnaire was finalized following expert review. This instrument is not a validated scale but a structured survey designed to descriptively assess students' knowledge, self-efficacy, and attitudes in the relevant fields, used solely for group comparisons and as descriptive data in this study.

Data Collection Procedure: Data were collected online via the Google Forms platform in July 2026. Participants were reached through digital platforms, and the purpose of the study and its voluntary basis were clearly explained. Collected data are anonymous, and no identifying information was requested from participants.

Ethical Approval: The study was approved by the Lokman Hekim University Scientific Research and Non-Drug and Non-Medical Device Clinical Research Ethics Committee and was conducted in accordance with the principles of the Declaration of Helsinki.

Statistical Analysis: Data were analyzed using IBM SPSS Statistics for Windows, Version 26.0 (IBM Corp., NY, USA). Distribution characteristics of continuous variables were assessed using histograms, normal Q-Q plots, and the Shapiro-Wilk test. Continuous variables with normal distribution were presented as mean±standard deviation, while those without normal distribution were presented as median (minimum-maximum). Categorical variables were expressed as n (%). Although a psychometric validity and reliability study of the questionnaire was not the aim of this study, Cronbach's alpha coefficients were calculated and reported to evaluate the internal consistency of items grouped under the knowledge, self-efficacy, and attitude subdimensions and to support the usability of subdimension total scores in descriptive and comparative analyses. The Mann-Whitney U test was used to compare age, knowledge, self-efficacy, and attitude scores according to class level. An independent samples t-test was applied to compare GPA according to class level. The Pearson chi-square test was used to compare categorical variables according to class level. In the comparison of knowledge, self-efficacy, and attitude scores according to clinical experience variables, the Mann-Whitney U test was used for two-category variables, and the Kruskal-Wallis test was used for the four-category variable of participation in application processes. For variables with a significant difference on the Kruskal-Wallis test, pairwise comparisons were performed using the Mann-Whitney U test with Bonferroni correction (significance level accepted as 0.0083). The relationships between GPA and knowledge, self-efficacy, and attitude scores were evaluated using Spearman's rank correlation analysis. Statistical significance was accepted as p<0.05 in all analyses.

Expected Outcomes: This study is expected to provide novel data on the knowledge, self-efficacy, and attitudes of physiotherapy and rehabilitation students regarding orthotic and prosthetic rehabilitation-an area with a critical but understudied role within undergraduate education. The findings are anticipated to identify specific gaps, such as limited self-efficacy in technical application skills and role recognition of orthotic and prosthetic specialists, and to inform curriculum development, the design of skills laboratories and simulation-based training, and strategies to strengthen interprofessional collaboration between physiotherapy and orthotics-prosthetics professionals, ultimately contributing to improved quality of rehabilitation services for patients using orthotic and prosthetic devices.

Being tested
Administration of the Prosthetics and Orthotics Awareness Questionnaire
Keywords
Orthotics, Prosthetics, Physiotherapy Students;, Self-Efficacy, Attitudes, Knowledge, Rehabilitation
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Administration of the Prosthetics and Orthotics Awareness QuestionnaireOther

    Participants will complete the 32-item Prosthetics and Orthotics Awareness Questionnaire and a demographic information form once through an online survey. The questionnaire assesses students' self-reported knowledge, perceived self-efficacy, attitudes, educational needs, and views regarding multidisciplinary collaboration in prosthetics and orthotics rehabilitation. Completion of the forms is expected to take approximately 10-15 minutes. No therapeutic, educational, or behavioral intervention will be administered.

Study groups in NCT07734402
Study groupRoleWhat they receive
Third-Year Physiotherapy StudentsThis cohort includes third-year students (n=68) enrolled in the undergraduate Physiotherapy and Rehabilitation program at Lokman Hekim University, Faculty of Health Sciences, who have completed theoretical coursework related to orthotic and prosthetic rehabilitation and voluntarily agreed to participate. Participants completed a demographic information form and the Orthotics and Prosthetics Awareness Questionnaire, which assesses knowledge, self-efficacy, and attitudes regarding orthotic and prosthetic rehabilitation across three subdimensions: Knowledge, Self-Efficacy, and Attitude.
Receives: Other: Administration of the Prosthetics and Orthotics Awareness Questionnaire
Fourth-Year Physiotherapy StudentsThis cohort includes fourth-year students (n=65) enrolled in the undergraduate Physiotherapy and Rehabilitation program at Lokman Hekim University, Faculty of Health Sciences, who have completed theoretical coursework related to orthotic and prosthetic rehabilitation and voluntarily agreed to participate. Fourth-year students have additionally completed clinical internship rotations, providing greater exposure to orthotic and prosthetic patients. Participants completed the same demographic form and the Orthotics and Prosthetics Awareness Questionnaire as the third-year cohort.
Receives: Other: Administration of the Prosthetics and Orthotics Awareness Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knowledge, Self-Efficacy, and Attitude Scores on the Orthotics and Prosthetics Awareness Questionnaire

    Participants completed the Orthotics and Prosthetics Awareness Questionnaire, a 32-item self-report survey developed by the investigators and rated on a 5-point Likert scale (1=Strongly Disagree, 5=Strongly Agree). The questionnaire has three subdimensions: Knowledge (11 items, e.g., ability to define orthoses/prostheses and their clinical indications), Self-Efficacy (9 items, e.g., confidence in selecting devices and contributing to patient rehabilitation), and Attitude (12 items, e.g., beliefs about the importance of orthotic/prosthetic care and interprofessional collaboration). Subdimension scores were calculated by summing item responses; higher scores indicate greater self-reported knowledge, self-efficacy, and positive attitude toward orthotic and prosthetic rehabilitation.

    Measured: Baseline (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion10 Oct 2026 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07734402
Sponsor's protocol ID
LHU-FTR-2026-001
Status last verified
Jun 2026
First submitted
24 Jul 2026
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared, as the study protocol and informed consent process guarantee participant anonymity and confidentiality. No identifying information (name, ID number) was collected from participants. Data will be stored securely, accessible only to the study investigators, and will be reported only in aggregated and anonymized form in scientific publications and presentations.

Publications

  • Alruwaili A, Mumenah N, Alharthy N, Othman F. Students' readiness for and perception of Interprofessional learning: a cross-sectional study. BMC Med Educ. 2020 Oct 29;20(1):390. doi: 10.1186/s12909-020-02325-9.

    PubMed 33121482
  • Gilbert JH, Yan J, Hoffman SJ. A WHO report: framework for action on interprofessional education and collaborative practice. J Allied Health. 2010 Fall;39 Suppl 1:196-7.

    PubMed 21174039
  • Haque F, Daniel M, Clay M, Vredeveld J, Santen S, House JB. The Interprofessional Clinical Experience: Introduction to Interprofessional Education Through Early Immersion in Health Care Teams. MedEdPORTAL. 2017 Mar 30;13:10564. doi: 10.15766/mep_2374-8265.10564.

    PubMed 30800766
  • Ash S, O'Connor J, Anderson S, Ridgewell E, Clarke L. A mixed-methods research approach to the review of competency standards for orthotist/prosthetists in Australia. Int J Evid Based Healthc. 2015 Jun;13(2):93-103. doi: 10.1097/XEB.0000000000000038.

    PubMed 26057653
  • Abaoğlu H, Cesim ÖB, Kars S, Akel S. Sağlık bilimlerinde öğrenim gören üniversite öğrencilerinin interdisipliner ekip çalışmasına bakışının incelenmesi. Hacettepe University Faculty of Health Sciences Journal. 2018;5(2):67-7

  • Reeves S, Perrier L, Goldman J, Freeth D, Zwarenstein M. Interprofessional education: effects on professional practice and healthcare outcomes (update). Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD002213. doi: 10.1002/14651858.CD002213.pub3.

    PubMed 23543515
  • Aminian G, O'Toole JM, Mehraban AH. Undergraduate prosthetics and orthotics teaching methods: A baseline for international comparison. Prosthet Orthot Int. 2015 Aug;39(4):278-85. doi: 10.1177/0309364614531009. Epub 2014 May 20.

    PubMed 24844617
  • Farhat S, Hammoud Z, Maatouk R, Barakat M, Kotaich J, Abou Chakra A, Chidiac J, Mechleb A, Salameh P. Awareness Level, Knowledge and Attitude Among Lebanese Medical Students Towards Interprofessional Collaboration Between Healthcare Professionals: A Cross-Sectional National Study. Cureus. 2025 Dec 17;17(12):e99445. doi: 10.7759/cureus.99445. eCollection 2025 Dec.

    PubMed 41552159

Questions about this trial

What is this clinical trial studying?

An observational study of Orthotic and Prosthetic Rehabilitation, run by Lokman Hekim University at 1 site in Turkey (Türkiye).

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 5 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: opening soon, as of the sponsor's last update on 30 Jul 2026. 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Demet Öztürk, Assistant Professor (+90 506 839 42 88, demet.ozturk@lokmanhekim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge, Self-Efficacy, and Attitude Scores on the Orthotics and Prosthetics Awareness Questionnaire (time frame: Baseline (Day 1)). 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 NCT07734402, which also lists 8 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 30 Jul 2026.

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