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IRCT20200315046784N3 IRCT 2023-11-28 Iran University of Medical Sciences Effect of external ankle support in patients with chronic ankle instability CAI Effect of ankle support orthosis and kinesiotape on force control, muscle strength, and kinesiphobia in subjects with chronic ankle instability: A randomized controlled trial 2023-12-11 anticipated 60 Complete https://irct.ir/trial/73746 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The group allocation will be performed through permuted block randomization at an assignment ratio of 1:1:1. For allocation concealment, the randomization codes will be kept in opaque, sealed, sequentially numbered envelopes. Sample size is estimated at 51, however, to take account of potential withdrawals, 60 patients (n=20 per group) will be recruited for the study. First, create and seal 20 treatment A envelopes, 20 treatment B envelopes, and 20 treatment C envelopes. To create a block of 6, we will select 2 treatment A envelopes, 2 treatment B envelopes, and 2 treatment C envelopes. W will shuffle these 6 envelopes thoroughly, and place this block of 6 in a separate pile. Then, we will prepare additional blocks of 6 until all 20 treatment A, B, and C envelopes have been used. All additional blocks will be placed in their own individual piles. We will have 10 individuals piles of shuffled blocks of 6, Blinding description: The outcome assessor will be blinded to group allocation, because all dependent variables will be measured without the orthosis and or kinesiotape, and the patients will remove their orthosis / kinesiotape before referring for post-intervention assessment. Furthermore, all data will be encoded to prevent bias and to blind the statistician. N/A chronic ankle instability. Intervention 1: Intervention group: Group A will be received an ankle support orthosis. The patients will be asked to wear the orthosis for 4 weeks. Intervention 2: Intervention group: Group B: kinesiotape will be re-applied every 3 days, for 4 weeks. Intervention 3: Control group: no-intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is not a plan to make this available.
public Fatemeh Azadinia
Shahnazari st., Mother Sq., Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 azadinia.fatemeh@yahoo.com Iran University of Medical Sciences scientific Fatemeh Azadinia
Shahnazari st., Mother Sq., Mirdamad Blvd
Tehran Iran (Islamic Republic of) 1545913487 +98 918 130 9366 azadinia.fatemeh@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) aged 18 - 40. at least one significant ankle sprain at least 12 months ago that resulted in pain, swelling, and physical activity restriction for at least 1 day. have not sprained their ankle within the six weeks prior to study onset. feeling of instability, at least two episodes of giving way in the past 6 months. Ankle instability Instrument: answer "yes" to at least 5 yes/no questions (This should include question 1, plus 4 others) Cumberland Ankle Instability Tool. Score of =<24. 20 min or greater of moderate physical activity level at least 3 days. having no mechanical instability. 18 years 40 years Both History of lower extremity injury, fracture, surgery or acute trauma in either lower extremity in the previous 3 months, or time since the last sprain of less than 3 months. diabetes, neuropathies, neurological pathology. consumption of muscle relaxant during research period. not receiving of ankle orthosis, kinesiotape, and physical therapy over the last 6 months. leg length discrepancies. rheumatoid arthritis. congenital deformities. M25.37 Other instability, ankle and foot Treatment - Devices Treatment - Devices N/A Intervention group: Group A will be received an ankle support orthosis. The patients will be asked to wear the orthosis for 4 weeks. Intervention group: Group B: kinesiotape will be re-applied every 3 days, for 4 weeks. Control group: no-intervention Force sense. Timepoint: before and after 4 weeks. Method of measurement: Isokinetic Dynamometer. Force steadiness. Timepoint: before and after 4 weeks. Method of measurement: Isokinetic Dynamometer. Evertor muscles strength eccentric and concentric contractions. Timepoint: before and after 4 weeks. Method of measurement: Isokinetic dynamometer. Kinesiophobia/ fear of movement. Timepoint: before and after 4 weeks. Method of measurement: Tampa scale of kinesiphobia. Iran University of Medical Sciences Approved 2023-07-31 The ethics committee of Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)