- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07592208
Multilayer Inelastic Bandage Training in Physiotherapy Students
Evaluation of Skills, Interface Pressure Consistency and Confidence in Multilayer Compression Bandage Training for Physiotherapy Students: Quasi-experimental Study
The goal of this quasiexperimental study is to evaluate the effects of structured training on inelastic compression bandaging proficiency in fourth-year physiotherapy students. The main questions it aims to answer are:
Can supervised training significantly improve primary outcomes such as technical bandaging skills (measured by a standardized rubric)? Does structured education enhance secondary outcomes, including interface pressure accuracy, application time, and student self-confidence? Researchers will compare a Supervised Education Group receiving real-time biofeedback to a Control Group receiving an instructional brochure to see if expert-led training is more effective than passive learning in bridging the gap between perceived and actual clinical competence.
Participants will:
Perform a baseline bandaging application (T0) assessed via a two-station Objective Structured Practical Examination (OSPE).
Be assigned to either the supervised training session (with Kikuhime pressure sensors for feedback) or the brochure-based self-study group.
Complete a post-intervention assessment (T1) to measure improvements in technical skill, pressure precision, and self-confidence levels.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Objective: This study aimed to evaluate the effects of structured training on inelastic compression bandaging skills, interface pressure accuracy, and self-confidence among physiotherapy students.
Methods: This study was conducted with 41 physiotherapy students (Education Group: n=21; Control Group: n=20). The Education Group received supervised training with objective pressure feedback while the Control Group received an instructional brochure. Clinical bandaging skills were evaluated using a two-station Objective Structured Practical Examination (OSPE), consisting of standardized rubric and time, and interface pressure monitoring. Students were assessed at baseline (T0) and post-intervention (T1) for bandaging skills (via rubric), interface pressure (Kikuhime), application time (seconds), and self-confidence (VAS).
Results: At baseline, only 9.5% of the Education Group and 0% of the Control Group achieved the target pressure. Post-intervention, these rates increased to 33.3% and 35.0%, respectively. The Education Group demonstrated a significantly greater improvement in Rubric scores (p=0.030, rrb =0.390) and self-confidence levels (p=0.005, rrb =0.512) compared to the Control Group. Intra-group analysis revealed that application times increased significantly in both the Education (p<0.001, rrb =0.983) and Control groups (p<0.001, rrb =1.000). While absolute real pressure error improved significantly within the Education Group (p=0.024, rrb=0.581), no significant inter-group difference was found for pressure-related variables (p>0.05). Notably, in the Education Group, self-confidence showed a strong positive correlation with Rubric scores (rho= 0.619, p=0.003) and a significant negative moderate correlation with absolute real pressure error (rho: -0.408, p=0.037). In contrast, no significant correlation was found between confidence and technical performance in the Control Group, suggesting a tendency toward overconfidence.
Conclusion: Supervised training with objective feedback is superior to passive learning for mastering the complex psychomotor skill of multilayer inelastic bandaging. While theoretical instruction may artificially inflate self-confidence, it fails to bridge the experience paradox which perceived competence masks technical insufficiency. Integrating real-time biofeedback into physiotherapy curricula is essential to ensure sensory calibration, technical proficiency, and patient safety, transitioning students from conceptual understanding to objective clinical mastery.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Central
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Bolu, Central, Turecko (Türkiye), 14030
- Bolu Abant İzzet Baysal Üniversity
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Volunteering to participate
- Being a student in the department of physiotherapy and rehabilitation
- Being in the fourth year of study
- Having completed the Prosthetics and Rehabilitation course to ensure proficiency in the figure-of-eight bandaging technique.
Exclusion Criteria:
- Having any orthopedic or neurological disease that hinders upper extremity function, particularly hand use
- Presence of acute trauma to the upper extremity or hand
- Having a known allergy to compression materials, as students performed bandaging practices on one another.
- Students who had received any training or courses on compression bandaging prior to or outside of the 'Prosthetics and Rehabilitation' course
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Supervised Education Group
The supervised intervention consisted of a 3-hour session led by a lymphedema therapist with 14 years of experience. Training was conducted in groups of 5-9 students using peer-to-peer practice. The program included: Theory: Instruction on inelastic bandage properties, Laplace's Law, and pressure distribution principles. Demonstration: A step-by-step showcase of multi-layer below-knee bandaging, including stirrup and figure-of-eight techniques. Practice: Students practiced on peers in a supine position. Biofeedback: To master therapeutic pressure, students utilized the Kikuhime device for real-time monitoring. The instructor provided individual corrections for each application. This structured approach aimed to calibrate students' tactile perception and ensure technical mastery through expert supervision and objective feedback. |
The supervised intervention consisted of a 3-hour session led by a lymphedema therapist with 14 years of experience. Training was conducted in groups of 5-9 students using peer-to-peer practice. The program included: Theory: Instruction on inelastic bandage properties, Laplace's Law, and pressure distribution principles. Demonstration: A step-by-step showcase of multi-layer below-knee bandaging, including stirrup and figure-of-eight techniques. Practice: Students practiced on peers in a supine position. Biofeedback: To master therapeutic pressure, students utilized the Kikuhime device for real-time monitoring. The instructor provided individual corrections for each application. This structured approach aimed to calibrate students' tactile perception and ensure technical mastery through expert supervision and objective feedback. |
|
Aktivní komparátor: Control group
The control group was provided with a brochure detailing how to perform the bandaging.
All technical details provided in the supervised training were included in this brochure.
Visuals were used to demonstrate the final appearance of the stirrup technique, starting and ending positions, and the positioning of both the patient and the ankle.
Great care was taken to ensure that the visuals and descriptions were simple, clear, and explanatory.
After the brochure was distributed, any points of confusion were clarified for the students
|
The control group was provided with a brochure detailing how to perform the bandaging.
All technical details provided in the supervised training were included in this brochure.
Visuals were used to demonstrate the final appearance of the stirrup technique, starting and ending positions, and the positioning of both the patient and the ankle.
Great care was taken to ensure that the visuals and descriptions were simple, clear, and explanatory.
After the brochure was distributed, any points of confusion were clarified for the students
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Bandaging Skills
Časové okno: Baseline, and immediately after the intervention
|
A Bandaging Skills Rubric was developed to objectively evaluate bandaging proficiency.
To prevent bias, the rubric assessments were performed by a researcher who did not provide the training and who was specifically trained on each rubric criterion.
The rubric consisted of 5 criteria, each rated on a 3-point scale: Inadequate (1 point), Satisfactory (2 points), and Proficient (3 points).
The minimum and maximum possible scores for the rubric are 5 and 15, respectively.
Higher rubric scores indicate superior bandaging technique and quality.
|
Baseline, and immediately after the intervention
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Bandage Interface Pressure
Časové okno: Baseline, and immediately after the intervention
|
The students were instructed to apply the bandages within a pressure range of 35-45 mmHg.
Following the completion of the bandaging procedure, the interface pressure values at rest were recorded from B1 point (transition point of gastrocnemius tendon to muscle, from medial aspect of leg) in mmHg.
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Baseline, and immediately after the intervention
|
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Absolute real pressure error
Časové okno: Baseline, and immediately after the intervention
|
To determine how much the participants deviated from the desired pressure-that is, to find the actual error-calculations were performed before and after the application according to the following formula: Absolute error = |Pre-training interface pressure/Post-training interface pressure - Desired mean bandage pressure (40 mmHg)| These values were recorded as mmHg. |
Baseline, and immediately after the intervention
|
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Perceived Interface Pressure
Časové okno: Baseline, and immediately after the intervention
|
Physiotherapy students were asked to estimate the pressure they applied before and after the training, and their estimations were recorded in mmHg.
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Baseline, and immediately after the intervention
|
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Perceived pressure error
Časové okno: Baseline, and immediately after the intervention
|
the perceived error was calculated for both pre- and post-training applications. The perceived error was calculated with the formula. Perceived error = |Pre-training perceived mean interface pressure/ Post-training perceived mean interface pressure - Pre-training interface pressure/ Post-training interface|. The perceived error was recorded as mmHg. |
Baseline, and immediately after the intervention
|
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Confidence in Bandage Application
Časové okno: Baseline, and immediately after the intervention
|
The students' confidence in bandage application was evaluated using a Visual Analog Scale (VAS).
The students were asked how confident they felt in achieving the desired compression bandage pressure, and they were requested to mark their level of confidence on the VAS .
A score of '0' represented 'not confident at all,' while '10' represented 'highly confident.'
The marked point was measured with a ruler and recorded in centimeters
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Baseline, and immediately after the intervention
|
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Bandage application time
Časové okno: Baseline, and immediately after the intervention
|
The bandage application time was recorded in seconds before and after the training.
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Baseline, and immediately after the intervention
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Elif DUYGU-YILDIZ, Abant Izzet Baysal University
Publikace a užitečné odkazy
Obecné publikace
- 1. Trayes KP, Studdiford JS, Pickle S, Tully AS. Edema: diagnosis and management. American family physician. 2013;88:102-10. 2. Gasparis AP, Kim PS, Dean SM, Khilnani NM, Labropoulos N. Diagnostic approach to lower limb edema. Phlebology. 2020;35:650-5. 3. Michelini S, Failla A, Moneta G, Fiorentino A, Marco C. Peripheral Edema: differential diagnosis. In: Inflammation in the 21st Century. IntechOpen; 2020. 4. Miller CL, Colwell AS, Horick N, Skolny MN, Jammallo LS, O'Toole JA, et al. Immediate implant reconstruction is associated with a reduced risk of lymphedema compared to mastectomy alone: A prospective cohort study. Annals of surgery. 2016;263:399. 5. Klein I, Tidhar D, Kalichman L. Lymphatic treatments after orthopedic surgery or injury: a systematic review. Journal of bodywork and movement therapies. 2020;24:109-17. 6. de Almeida Alcantara DA, Dos Santos FNA, de Almeida Ferreira JJ, de Noronha M, de Andrade PR. The effect of kinesiotaping on edema: A systematic review and meta-analysis. Musculoskeletal Science and Practice. 2024;:103168. 7. Feger MA, Goetschius J, Love H, Saliba SA, Hertel J. Electrical stimulation as a treatment intervention to improve function, edema or pain following acute lateral ankle sprains: A systematic review. Physical Therapy in Sport. 2015;16:361-9. 8. Wang Z-R, Ni G-X. Is it time to put traditional cold therapy in rehabilitation of soft-tissue injuries out to pasture? World journal of clinical cases. 2021;9:4116. 9. Patel H, Skok CC, DeMarco A. Peripheral edema: evaluation and management in primary care. American Family Physician. 2022;106:557-64. 10. Sun C-R, Liu M-Y, Ni Q-H, Cai F, Tang F, Yu Z-Y, et al. Clinical Guidelines on Compression Therapy in Venous Diseases. Annals of Vascular Surgery. 2024. 11. Partsch H, Rockson SG. Compression therapy. Lymphedema: A Concise Compendium of Theory and Practice. 2018;:431-41. 12. Partsch H. Compression therapy: clinical and experimental evidence. Annals of vascular diseases. 2012;:ra-12.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
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První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- BAIBU-FTR-ED-005
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