NCT07592208

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

May 6, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

compression therapymultilayer inelastic bandage trainingphysiotherapy and rehabilitationInterface pressurePhysiotherapy education

Outcome Measures

Primary Outcomes (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.

    Baseline, and immediately after the intervention

Secondary Outcomes (6)

  • Bandage Interface Pressure

    Baseline, and immediately after the intervention

  • Absolute real pressure error

    Baseline, and immediately after the intervention

  • Perceived Interface Pressure

    Baseline, and immediately after the intervention

  • Perceived pressure error

    Baseline, and immediately after the intervention

  • Confidence in Bandage Application

    Baseline, and immediately after the intervention

  • +1 more secondary outcomes

Study Arms (2)

Supervised Education Group

EXPERIMENTAL

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.

Other: Supervised Education Group

Control group

ACTIVE COMPARATOR

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

Other: Brochure

Interventions

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.

Supervised Education 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

Control group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Central, 14030, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    BACKGROUND

Study Officials

  • Elif DUYGU-YILDIZ

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Quasi-experimental
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof.

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 18, 2026

Study Start

September 1, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations