AzTrials
AzTrials

Education, Competency-BasedNCT07592208

Multilayer Inelastic Bandage Training in Physiotherapy Students

A study testing Supervised Education Group and Brochure in people with Education, Competency-Based and Student, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Supervised Education Group and Brochure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2025to 30 Apr 2026
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bolu Abant Izzet Baysal University

    Bolu, Central, 14030

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Supervised Education Group, Brochure
Keywords
compression therapy, multilayer inelastic bandage training, physiotherapy and rehabilitation, Interface pressure, Physiotherapy education

What participants receive

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

  • Supervised Education GroupOther

    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.

  • BrochureOther

    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

Study groups in NCT07592208
Study groupRoleWhat they receive
Supervised Education GroupExperimentalThe 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.
Receives: Other: Supervised Education Group
Control groupActive comparatorThe 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
Receives: Other: Brochure

What is being measured

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

  1. Bandaging Skills

    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.

    Measured: Baseline, and immediately after the intervention

Secondary outcomes (6)
  1. Bandage Interface Pressure

    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.

    Measured: Baseline, and immediately after the intervention

  2. Absolute real pressure error

    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.

    Measured: Baseline, and immediately after the intervention

  3. Perceived Interface Pressure

    Physiotherapy students were asked to estimate the pressure they applied before and after the training, and their estimations were recorded in mmHg.

    Measured: Baseline, and immediately after the intervention

  4. Perceived pressure error

    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.

    Measured: Baseline, and immediately after the intervention

  5. Confidence in Bandage Application

    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

    Measured: Baseline, and immediately after the intervention

  6. Bandage application time

    The bandage application time was recorded in seconds before and after the training.

    Measured: Baseline, and immediately after the intervention

Timeline

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

  1. First posted18 May 2026
  2. Study start1 Sep 2025
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Quasi-experimental
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07592208
Sponsor's protocol ID
BAIBU-FTR-ED-005
Status last verified
May 2026
First submitted
6 May 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Supervised Education Group and Brochure in people with Education, Competency-Based and Student, run by Abant Izzet Baysal 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 4 inclusion and 4 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 18 May 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?

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?

Bandaging Skills (time frame: Baseline, and immediately after the intervention). 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 NCT07592208, 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 18 May 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in