NCT03815526

Brief Summary

Injuries to the ankle joint account for 20% of the population that is afflicted with joint injury and the largest percentage of self-reported musculoskeletal injuries (\> 10%) are to the ankle. Ankle sprain has a large portion in ankle injuries and occurs not only in the sporting population but also in the general community. Although the acute symptom would be resolve quickly, but many people still report persisting problems, such as pain and instability. Chronic ankle instability (CAI) is one of the most common of these residual problems. Kinesio Tape and White Duck Tape are often applied in patients with CAI, attempt to increase the ankle joint stability, and improve motor performance. However, the previous studies had controversial result to the effects of kinesio tape and white duck tape. The previous studies also showed the insufficient of supporting force and elasticity of kinesio tape and white duct tape. The Dynamic Tape was developed by Kendrick in 2009, which refined the characteristic of elasticity and supporting force. Therefore the purpose of study is to comparison the effects of static and dynamic balance performance, weight shifting ability and functional movement between kinesio tape, white duck tape and dynamic tape when applied on patients with CAI. With the result may provide an optical method to increase the movement performance of patients with CAI. The study suspected to recruit 90 volunteers with CAI, and randomly divided to three different groups: Kinesio tape group, White duck tape group and Dynamic tape group. We make postural stability test and limit postural stability test with Biodex Balance System (SD), Y-balance test and single leg hop test to both affected side and sound side foot before applying the tape. After applying the tape according to the divided group, we will repeat the test above again. We will compare the results of the test between groups and within groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 9, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 29, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

January 9, 2019

Last Update Submit

October 28, 2019

Conditions

Keywords

DynamicTapeSport TapeKinesio Tape

Outcome Measures

Primary Outcomes (1)

  • Biodex Balance System

    Overall Stability Index, Anterior/Posterior Index, Medial/Lateral Index Limits of stability direction control score (Overall, Forward, Backward, Right, Left, Forward/Right, Forward/Left, Backward/Right, Backward/Left)

    1 day

Secondary Outcomes (2)

  • Y-balance test

    1 day

  • Single leg hop test

    1 day

Study Arms (3)

Dynamic tape

EXPERIMENTAL
Other: Dynamic tape

Kinesio tape

EXPERIMENTAL
Other: Kinesio tape

Sport tape

EXPERIMENTAL
Other: Sport tape

Interventions

Dynamic tape apply 1 time

Dynamic tape

Dynamic tape apply 1 time

Kinesio tape

Dynamic tape apply 1 time

Sport tape

Eligibility Criteria

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

You may qualify if:

  • A history of at least one significant ankle sprain
  • The initial sprain must have occurred at least 12 months prior to the study enrolment
  • Was associated with inflammatory symptoms (pain, swelling, etc)
  • Created at least one interrupted day of desired physical activity
  • A history of the previously injured ankle joint 'giving way' , and /or recurrent sprain and/or 'feelings of instability'.

You may not qualify if:

  • A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures and nerves) in either lower extremity.
  • A history of a fracture in either lower extremity requiring realignment.
  • Acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 1 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wanfang Hospital

Taipei, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Ankle Injuries

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Central Study Contacts

Chien-Yung CY Wang, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 24, 2019

Study Start

May 10, 2019

Primary Completion

December 31, 2019

Study Completion

January 1, 2020

Last Updated

October 29, 2019

Record last verified: 2019-01

Locations