None listed
Conditions
Brief summary
Ankle braces have been proven to prevent ankle sprain, in both people who have never sprained an ankle and those who are recurrent sprainers (Doherty et al, 2017). The downside is that braces affect the mobility of the foot as they restrict all joints they pass over, and so often affect performance in activities such as walking, jumping and hopping (Doherty et al, 2017). This is of concern as braces are often applied in potential ankle spraining situations, such as sport, where performance should be optimal. To address this issue, the KISS® ankle brace was designed to allow unrestricted ankle and foot joint movement within normal ranges, whilst supporting the subtalar joint and restricting only end-range joint motion. To date, there are no studies investigating whether this claim is true. Thus, the aim of this study is to investigate whether the KISS® ankle brace maintains functional performance, immediately after application and after a period of adaption to the brace, compared with a standard brace condition. Additionally, to identify whether the KISS® ankle brace achieves the aim of being easy to apply, light weight, comfortable, and unnoticeable during activity.
Interventions
The KISS® ankle brace is a new device created to only restrict end of inversion range movement, (the usual ankle spraining movement). An independent person (honors or PhD student) trained to properly fit ankle braces will apply ankle braces and markers appropriately. The main investigators (honors or PhD student) will remain blinded until the trial is completed, and concealment will only be broken to primary investigator/s once measurements are recorded at the end of the trial. participants wil
The KISS® ankle brace is a new device created to only restrict end of inversion range movement, (the usual ankle spraining movement). An independent person (honors or PhD student) trained to properly fit ankle braces will apply ankle braces and markers appropriately. The main investigators (honors or PhD student) will remain blinded until the trial is completed, and concealment will only be broken to primary investigator/s once measurements are recorded at the end of the trial. participants will be wearing the ankle brace during the testing session (2.5 hours) and required to complete a number of tasks including; side hop test, star excursion balance test, triple hop test, agility t test, standing vertical jump and maximum vertical jump. Follow up study will be one-week after test session were participants will be invited to take home the brace for the duration of the week during any weight-bearing activities or at their discretion to wear and will come back for a follow-up session which they will wear for another 2.5 hours. They will receive instructions on how to appropriately fit the brace. Participants will be asked to return the brace when they return for the 1-week follow-up. A Work boot sock protector will be worn over the ankle (but not restrict the brace or ankle, or the shoe/floor interface) to conceal the brace or no brace condition from the primary tester. It will also conceal the brace type from the participants. The braces will also have the manufacturers markings removed or erased with indelible ink There is NO washout period: participants will be tested in ALL conditions on the same day.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for CAI group: * Age 18-65 years * History of at least one previous ankle sprain * At least two episodes of the previously injured ankle experiencing recurrent sprains, ‘giving way’ or ‘feelings of instability’ in the past six months * Cumberland Ankle Instability Tool (CAIT) score <=24 *Proficient in English to complete the study questionnaires and understand instructions Inclusion criteria for control group: * Age 18-65 years * No previous history of ankle sprain * Cumberland Ankle Instability Tool (CAIT) score > 28 * Proficient in English to complete the study questionnaires and understand instructions
Exclusion criteria
Exclusion criteria for both groups: * A history of previous musculoskeletal surgery to either lower extremity * A history of a previous lower limb fracture requiring realignment * An acute musculoskeletal joint injury of the lower extremity in the past three months * A vestibular disorder or neurological disease
Outcome results
None listed