- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01423513
Effects of Ankle Support on Muscle Activation and Function
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68178
- Creighton University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Tape with be applied with tension.
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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
|
Tape will be applied without tension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in muscle activation
Time Frame: All study visits up to day 7
|
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
|
Changes in ankle dorsiflexion range of motion (ROM)
Time Frame: All study visits up to day 7
|
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
|
Changes in dynamic balance
Time Frame: All study visits up to day 7
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-16018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankle Sprain
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National Defense Medical Center, TaiwanTri-Service General HospitalRecruitingAnkle Sprain 2Nd Degree | Ankle Sprain 3Rd DegreeTaiwan
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Instituto Mexicano del Seguro SocialCompletedAnkle Sprain | Ankle Sprain 1St Degree | Ankle Sprain 2Nd DegreeMexico
-
Université Catholique de LouvainCompletedAnkle Sprain 1St Degree | Ankle Sprain 2Nd DegreeBelgium
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Vanderbilt University Medical CenterRecruitingMusculoskeletal Injury | Ankle Sprain 1St Degree | Ankle Sprain 2Nd DegreeUnited States
-
University of VirginiaNational Athletic Training Association Research & Education FoundationUnknownLateral Ankle SprainUnited States
-
Hospital Universitario Infanta LeonorCompletedMild Ankle SprainSpain
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University Hospital, GrenobleCompleted
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Université Catholique de LouvainUZ Leuven, campus Pellenberg (Belgium)RecruitingChronic Ankle Instability | Lateral Ankle SprainBelgium
Clinical Trials on Fibular Taping
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Assiut UniversityUnknown
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National Yang Ming UniversityCompleted
-
Oslo University HospitalVestre Viken Hospital Trust; Ostfold Hospital TrustActive, not recruiting
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Universidade Norte do ParanáUniversidade Estadual de LondrinaCompletedAnterior Knee Pain Syndrome
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University of ValenciaCompleted
-
Christian Medical College and Hospital, Ludhiana...Uppal Neuro Hospital; Heart and Brain Center, Guntur, Andhra Pradesh, IndiaCompleted
-
Muğla Sıtkı Koçman UniversityCompleted
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Lithuanian University of Health SciencesInternational Kinesio Taping associationCompleted