NCT03472924

Brief Summary

This study evaluates whether the use of Kinesio Tape® in combination with a standard exercise program improves muscle function in individuals with chronic ankle instability. Twenty participants will receive Kinesio Tape® and perform an ankle exercise program, while twenty will perform the ankle exercise program without Kinesio Tape®.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 14, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

March 19, 2024

Completed
Last Updated

March 19, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

March 14, 2018

Results QC Date

February 20, 2024

Last Update Submit

February 20, 2024

Conditions

Keywords

AMI

Outcome Measures

Primary Outcomes (2)

  • Change in Central Activation Ratio

    Ratio between maximal voluntary evertor torque and torque produced following the application of an exogenous electrical stimulus

    Change between baseline and 2 days post-intervention

  • Change in Rate of Torque Development

    Measure of explosive strength determined by placing a line of best fit to a recorded torque-time curve from onset to 100ms after onset

    Change between baseline and 2 days post-intervention

Secondary Outcomes (1)

  • Change in Maximal Voluntary Isometric Contraction

    Change between baseline and 2 days post-intervention

Study Arms (2)

Kinesio Tape

EXPERIMENTAL

Kinesiotaping of the peroneus longus according to the guidelines provided by the Kinesio Taping Association (Kase, K. 2016) followed by standardized set of therapeutic exercises that are commonly implemented in ankle rehabilitation programs.

Device: Kinesiotaping

Control

NO INTERVENTION

Baseline measures followed by standardized set of therapeutic exercises that are commonly implemented in ankle rehabilitation programs, but no use of kinesiotape.

Interventions

The application of Kinesio Tape® (kinesiotaping) according to the guidelines provided by the Kinesio Taping Association (Kase, K. 2016). A 5 cm width strip of Kinesio Tape® (Kinesio TEX Products, NKT-050, Japan) will be applied from origin (the head of the fibula) to insertion (the medial cuneiform and first metatarsal) of the peroneus longus in a longitudinal direction. The proximal anchors will be applied without tension, and the Kinesio Tape® placed on approximately 50% stretch before being applied over the peroneus longus and the distal anchor point.

Also known as: Kinesio Tape®
Kinesio Tape

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A history of at least one significant ankle sprain on the involved (injured) limb i. The initial sprain must have occurred at least 12 months prior to the study enrollment ii. Was associated with inflammatory symptoms (pain, swelling, etc.) iii. Created at least one interrupted day of desired physical activity.
  • The most recent injury on the involved (injured) ankle must have occurred more than 3 months prior to the study enrollment.
  • A history of the involved (injured) ankle joint 'giving way', and/or recurrent sprain and/or 'feelings of instability' on the involved (injured) limb Participants should report at least 2 episodes of 'giving way' in the 6 months prior to the study enrolment.
  • Be 18-35 years of age
  • Have not had a past allergic reaction to Kinesio Tape®

You may not qualify if:

  • Have a history of previous surgeries to the musculoskeletal structures (i.e., bones, joint structures, nerves, etc.) in either lower extremity.
  • Have a history of a fracture in either lower extremity requiring realignment.
  • Had acute injury to the musculoskeletal structures of other joints of either lower extremity in the previous 3 months which impacted joint integrity and function (i.e., sprains, fractures, etc.) and resulted in at least 1 interrupted day of desired physical activity.
  • Are not able to be matched according to our group allocation procedure
  • Have had a past allergic reaction to Kinesio Tape®
  • Currently display symptoms of an acute sprain including swelling, heat, redness, pain, discoloration, and/or loss of range of motion or function
  • Any diagnosed vestibular disorder, Charcot-Marie-Tooth disorder, Ehlers-Danlos, or other hereditary nerve, balance or connective tissue disorder
  • Report a possibility that they may be pregnant as hormonal changes may affect ligamentous laxity
  • Have suffered more than one ankle sprain on the uninvolved limb
  • Have had an ankle sprain on the uninvolved limb within the past 12 months
  • Have episodes of giving way of the ankle on the uninvolved limb besides the single time when they may have sprained this ankle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

Related Publications (3)

  • Akbas E, Atay AO, Yuksel I. The effects of additional kinesio taping over exercise in the treatment of patellofemoral pain syndrome. Acta Orthop Traumatol Turc. 2011;45(5):335-41. doi: 10.3944/AOTT.2011.2403.

    PMID: 22032998BACKGROUND
  • Yoshida A, Kahanov L. The effect of kinesio taping on lower trunk range of motions. Res Sports Med. 2007 Apr-Jun;15(2):103-12. doi: 10.1080/15438620701405206.

    PMID: 17578750BACKGROUND
  • McVey ED, Palmieri RM, Docherty CL, Zinder SM, Ingersoll CD. Arthrogenic muscle inhibition in the leg muscles of subjects exhibiting functional ankle instability. Foot Ankle Int. 2005 Dec;26(12):1055-61. doi: 10.1177/107110070502601210.

    PMID: 16390639BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Limitations and Caveats

Early termination of the study due inadequate participant enrollment. Results presented are for only 6 total participants and should be intrepreted with extreme caution.

Results Point of Contact

Title
Marc Norcross, PhD, ATC
Organization
Oregon State University

Study Officials

  • Marc F Norcross, PhD

    Oregon State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 21, 2018

Study Start

April 16, 2018

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

March 19, 2024

Results First Posted

March 19, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations