NCT01995318

Brief Summary

Study hypothesis: Kinesiotaping is effective in treatment of acute ankle sprains in emergency department. It enhances Karlsson score more than elastic bandage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

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

July 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
Last Updated

March 3, 2015

Status Verified

November 1, 2013

Enrollment Period

Same day

First QC Date

November 20, 2013

Last Update Submit

March 2, 2015

Conditions

Sprain of Ankle

Keywords

Kinesiotaping

Outcome Measures

Primary Outcomes (1)

  • Karlsson score enhancement

    0-3-7 and 28 days after injury

Study Arms (2)

Elastic bandage

PLACEBO COMPARATOR

Elastic bandage application as one of routine treatment choice of acute ankle sprains.

Kinesiotaping

OTHER

Application of anti-edema kinesiotaping

Other: Kinesiotaping

Interventions

KinesiotapingOTHER

Application of anti-edema type kinesiotaping to injured ankle.

Kinesiotaping

Eligibility Criteria

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

You may qualify if:

  • Patients in isolated acute ankle sprains in emergency department.

You may not qualify if:

  • Under 18 years
  • Pregnancy
  • Fracture
  • hours after injury
  • Chronic ankle instability
  • Nurologic deficit in lower extremity
  • Multipl trauma patients
  • Ankle, pelvis or knee surgery history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Education and Training Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Yahya A ACAR, MD

    Etimesgut Military Hospital Ankara/Turkey

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 26, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2013

Study Completion

November 1, 2013

Last Updated

March 3, 2015

Record last verified: 2013-11

Locations

TU(1)