Ankle SprainNCT01423513
Effects of Ankle Support on Muscle Activation and Function
A study testing Fibular Taping in people with Ankle Sprain, run by Creighton University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Fibular Taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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°
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Ankle Sprain
- Being tested
- Fibular Taping, Sham Taping
- Keywords
- ankle tape, Hoffmann reflex, Balance
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibular TapingOther
Tape with be applied with tension.
Sham TapingOther
Tape will be applied without tension
| Study group | Role | What they receive |
|---|---|---|
| Fibular Taping | Experimental | 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. Receives: Other: Fibular Taping |
| Sham Taping | Sham comparator | Sham taping will be applied in the same manner as the fibular taping, but tension will not applied to the zinc oxide tape Receives: Other: Sham Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: All study visits up to day 7
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.
Measured: All study visits up to day 7
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.
Measured: All study visits up to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- American Physical Therapy Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423513
- Sponsor's protocol ID
- 11-16018
- Status last verified
- Apr 2012
- First submitted
- 22 Aug 2011
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Grindstaff TL, Hanish MJ, Wheeler TJ, Basnett CR, Miriovsky DJ, Danielson EL, Barr JB, Joseph Threlkeld A. Fibular taping does not alter lower extremity spinal reflex excitability in individuals with chronic ankle instability. J Electromyogr Kinesiol. 2015 Apr;25(2):253-9. doi: 10.1016/j.jelekin.2015.01.009. Epub 2015 Feb 16.
PubMed 25727519
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ankle Support on Muscle Activation and Function
- ClinicalTrials.gov ID
- NCT01423513
- Acronym / sponsor ID
- 11-16018
- Conditions
- Ankle Sprain
- Keywords
- ankle tape, Hoffmann reflex, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- American Physical Therapy Association
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibular Taping | Experimental | Other: Fibular TapingWith 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. |
| Sham Taping | Sham comparator | Other: Sham TapingSham taping will be applied in the same manner as the fibular taping, but tension will not applied to the zinc oxide tape |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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°
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibular TapingTape with be applied with tension. | Other | Fibular Taping |
| Sham TapingTape will be applied without tension | Other | Sham Taping |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Derived from this study: PubMed 25727519Grindstaff TL, Hanish MJ, Wheeler TJ, Basnett CR, Miriovsky DJ, Danielson EL, Barr JB, Joseph Threlkeld A. Fibular taping does not alter lower extremity spinal reflex excitability in individuals with chronic ankle instability. J Electromyogr Kinesiol. 2015 Apr;25(2):253-9. doi: 10.1016/j.jelekin.2015.01.009. Epub 2015 Feb 16.
Related trials for Ankle Sprain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Recruiting
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains
RecruitingObservational study
Computed Tomography With Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability (CTMETS)
Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibular Taping in people with Ankle Sprain, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in muscle activation (time frame: All study visits up to day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01423513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016; AzTrials last refreshed its copy on 31 Oct 2026.