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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01423513
Other study ID # 11-16018
Secondary ID
Status Completed
Phase N/A
First received August 22, 2011
Last updated March 3, 2016
Start date March 2011
Est. completion date March 2012

Study information

Verified date April 2012
Source Creighton University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of ankle taping on improving muscle function and ankle motion in individuals who frequently twist (sprain) their ankle. It is thought that ankle taping may increase muscle function and ankle motion which would benefit individuals who frequently sprain their ankle.


Description:

Previous research has demonstrated improved dynamic balance following the application of fibular taping. The effects of fibular taping on ankle dorsiflexion ROM and muscle activation in individuals with CAI are unknown. The purpose of this study is to determine the acute effects of fibular taping on muscle activation of the fibularis longus (peroneus) and soleus muscles, ankle dorsiflexion range of motion (ROM) and dynamic balance. The investigators hypothesize that fibular taping will have similar effectiveness as mobilization interventions which have been shown to improve muscle activation, ankle dorsiflexion ROM,and dynamic balance. Outcomes will be measured immediately before and after intervention. A crossover design will be used and participants will complete two visits at least 48 hours apart, but not more than 1 week apart. After participants complete both arms of the study their participation will be complete (average time to completion for each subject is 1 week).


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 45 Years
Eligibility Inclusion Criteria:

- Age 16-45 years

- History of one or more ankle sprains

- Scoring at least an 85% on the Foot and Ankle Ability Measure (FAAM) Sport or at least 3 on the Modified Ankle Instability Instrument (AII).

- At least 5° ankle dorsiflexion asymmetry compared to the contralateral limb OR ankle dorsiflexion ROM less than 21°

Exclusion Criteria:

- Lower extremity injury or surgery within the past 6 months (including lateral ankle sprain)

- Diagnosed ankle osteoarthritis

- History of ankle surgery that involves intra-articular fixation

- Potential for current pregnancy

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Fibular Taping
Tape with be applied with tension.
Sham Taping
Tape will be applied without tension

Locations

Country Name City State
United States Creighton University Omaha Nebraska

Sponsors (2)

Lead Sponsor Collaborator
Creighton University American Physical Therapy Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in muscle activation To determine the changes in muscle activation of the fibularis longus and soleus muscles following a fibular taping or sham taping intervention in individuals with CAI. Changes in muscle activation will be quantified by assessing the H-reflex technique before and after intervention.
Hypothesis: We hypothesize that the fibular taping intervention will result in a greater activation of the fibularis longus and soleus muscles than a sham taping intervention.
All study visits up to day 7 No
Primary Changes in ankle dorsiflexion range of motion (ROM) To determine the changes in ankle dorsiflexion ROM following a fibular taping or sham taping intervention in individuals with CAI. Changes in ankle dorsiflexion ROM will be quantified using a weight bearing lunge.
Hypothesis: We hypothesize that the fibular taping intervention will result in a greater improvement in ankle dorsiflexion ROM than the sham taping intervention.
All study visits up to day 7 No
Primary Changes in dynamic balance To determine the acute changes in balance following a fibular taping or sham taping intervention in individuals with CAI. Changes in balance will be quantified using the the Star Excursion Balance Test (SEBT).
Hypothesis: We hypothesize that the fibular taping intervention will result in greater improvements in reach distance in all three SEBT directions compared to the sham taping intervention.
All study visits up to day 7 No
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