Ankle FracturesKT-WeberBNCT06958133
Effects of Postoperative Kinesio Taping in Weber Type B Lateral Malleolar Fractures
A study testing Standard Postoperative Rehabilitation and Kinesio Taping in people with Ankle Fractures and Syndesmotic Injuries, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Fractures, Syndesmotic Injuries, Postoperative Rehabilitation
- What is being tested?
- Standard Postoperative Rehabilitation and Kinesio Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2024to 20 Mar 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, ataşehir, 34752
About this study
Official title: The Effects of Postoperative Kinesio Taping on Pain, Range of Motion, and Edema in Weber Type B Lateral Malleolar Fractures: A Randomized Controlled Trial
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.
Read the detailed description
Patients with Weber type B lateral malleolar fractures treated surgically were randomized into two groups: a control group receiving standard rehabilitation and an intervention group receiving additional Kinesio taping. Outcomes assessed included visual analog scale (VAS) pain scores, dorsiflexion range of motion, and circumferential edema measurements at 1, 7, and 28 days postoperatively.
- Being tested
- Standard Postoperative Rehabilitation, Kinesio Taping
- Keywords
- ankle fractures, kinesiology
- Medical subject headings
- Ankle Fractures, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Postoperative RehabilitationOther
Standard rehabilitation protocol after surgical fixation of Weber type B ankle fractures without Kinesio taping.
Kinesio TapingOther
Kinesio taping applied over the surgical ankle to assist in reducing postoperative pain, swelling, and improving range of motion.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Standard postoperative rehabilitation without Kinesio taping. Receives: Other: Standard Postoperative Rehabilitation |
| Kinesio Taping Group | Other | Standard postoperative rehabilitation plus Kinesio taping application. Receives: Other: Standard Postoperative Rehabilitation; Other: Kinesio Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (1)
Change in ankle dorsiflexion range of motion at 4 weeks, measured in degrees using a goniometer.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start25 Nov 2024
- Primary completion10 Jan 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958133
- Sponsor's protocol ID
- KT-WeberB-2025
- Acronym
- KT-WeberB
- Status last verified
- May 2025
- First submitted
- 26 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Postoperative Kinesio Taping on Pain, Range of Motion, and Edema in Weber Type B Lateral Malleolar Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06958133
- Acronym / sponsor ID
- KT-WeberB / KT-WeberB-2025
- Keywords
- ankle fractures, kinesiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with Weber type B lateral malleolar fractures treated surgically were randomized into two groups: a control group receiving standard rehabilitation and an intervention group receiving additional Kinesio taping. Outcomes assessed included visual analog scale (VAS) pain scores, dorsiflexion range of motion, and circumferential edema measurements at 1, 7, and 28 days postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Standard Postoperative RehabilitationStandard postoperative rehabilitation without Kinesio taping. |
| Kinesio Taping Group | Other | Other: Standard Postoperative Rehabilitation, Other: Kinesio TapingStandard postoperative rehabilitation plus Kinesio taping application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Postoperative RehabilitationStandard rehabilitation protocol after surgical fixation of Weber type B ankle fractures without Kinesio taping. | Other | Control Group, Kinesio Taping Group |
| Kinesio TapingKinesio taping applied over the surgical ankle to assist in reducing postoperative pain, swelling, and improving range of motion. | Other | Kinesio Taping Group |
Primary outcome
Change in pain levels assessed by Visual Analog Scale (VAS) at 4 weeks postoperatively
Time frame: 28 days
VAS scores ranging from 0 (no pain) to 10 (worst pain) measured at postoperative day 1, day 7, and day 28.
1 secondary outcome
Change in ankle dorsiflexion range of motion at 4 weeks, measured in degrees using a goniometer.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Postoperative Rehabilitation and Kinesio Taping in people with Ankle Fractures and Syndesmotic Injuries, run by Fatih Sultan Mehmet Training and Research Hospital 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 6 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 6 May 2025. 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?
Change in pain levels assessed by Visual Analog Scale (VAS) at 4 weeks postoperatively (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025.