Effects of Ankle Support on Muscle Activation and Function

This study has been completed.

Sponsor:

Collaborator:

American Physical Therapy Association

Information provided by (Responsible Party):

Creighton University

ClinicalTrials.gov Identifier:

NCT01423513

First received: August 22, 2011

Last updated: April 11, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 22, 2011
Last Updated Date	April 11, 2012
Start Date ^ICMJE	March 2011
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 25, 2011)	Changes in muscle activation [ Time Frame: All study visits up to day 7 ] [ Designated as safety issue: No ] 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. Changes in ankle dorsiflexion range of motion (ROM) [ Time Frame: All study visits up to day 7 ] [ Designated as safety issue: No ] 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. Changes in dynamic balance [ Time Frame: All study visits up to day 7 ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01423513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Ankle Support on Muscle Activation and Function
Official Title ^ICMJE	Effects of Ankle Support on Muscle Activation and Function
Brief 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.
Detailed 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).
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Ankle Sprain
Intervention ^ICMJE	Other: Fibular Taping Tape with be applied with tension. Other: Sham Taping Tape will be applied without tension
Study Arm (s)	Experimental: Fibular Taping With the ankle in a neutral position, two strips of nonrigid hypoallergenic tape will be applied beginning at the distal aspect of the fibula, wrapping around the posterior aspect of the leg, and finishing superior and medial to the starting point. Next,a strip of rigid zinc oxide tape will be applied to the distal aspect of the fibula with tension. Intervention: Other: Fibular Taping Sham Comparator: Sham Taping Sham taping will be applied in the same manner as the fibular taping, but tension will not applied to the zinc oxide tape Intervention: Other: Sham Taping
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	26
Completion Date	March 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	16 Years to 45 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01423513
Other Study ID Numbers ^ICMJE	NCT001116018
Has Data Monitoring Committee	No
Responsible Party	Creighton University
Study Sponsor ^ICMJE	Creighton University
Collaborators ^ICMJE	American Physical Therapy Association
Investigators ^ICMJE	Not Provided
Information Provided By	Creighton University
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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