NCT06958133

Brief Summary

This randomized controlled trial aimed to evaluate the effects of postoperative Kinesio taping on pain, range of motion, and edema in patients undergoing surgical fixation for Weber type B lateral malleolar fractures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 26, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

April 26, 2025

Last Update Submit

May 3, 2025

Conditions

Keywords

ankle fractures, kinesiology

Outcome Measures

Primary Outcomes (1)

  • Change in pain levels assessed by Visual Analog Scale (VAS) at 4 weeks postoperatively

    VAS scores ranging from 0 (no pain) to 10 (worst pain) measured at postoperative day 1, day 7, and day 28.

    28 days

Secondary Outcomes (1)

  • Change in ankle dorsiflexion range of motion at 4 weeks, measured in degrees using a goniometer.

    28 days

Study Arms (2)

Control Group

OTHER

Standard postoperative rehabilitation without Kinesio taping.

Other: Standard Postoperative Rehabilitation

Kinesio Taping Group

OTHER

Standard postoperative rehabilitation plus Kinesio taping application.

Other: Standard Postoperative RehabilitationOther: Kinesio Taping

Interventions

Standard rehabilitation protocol after surgical fixation of Weber type B ankle fractures without Kinesio taping.

Control GroupKinesio Taping Group

Kinesio taping applied over the surgical ankle to assist in reducing postoperative pain, swelling, and improving range of motion.

Kinesio Taping Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years
  • Patients diagnosed with isolated Weber type B lateral malleolar fractures requiring surgical fixation
  • Surgery performed within 7 days of injury
  • Written informed consent provided

You may not qualify if:

  • Open fractures
  • Associated fractures of the medial or posterior malleolus requiring fixation
  • Polytrauma patients
  • History of previous ankle fractures or surgeries on the affected side
  • Neurological or vascular compromise of the affected limb
  • Known allergy to adhesive materials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, ataşehir, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle FracturesAnkle Injuries

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2025

First Posted

May 6, 2025

Study Start

November 25, 2024

Primary Completion

January 10, 2025

Study Completion

March 20, 2025

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations