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IRCT20220212054006N1 IRCT 2022-03-26 Tehran University of Medical Sciences Effects of a progressive balance training program with and without medial wedge on chronic ankle instability Effects of a progressive balance training program with and without medial wedge on postural control of patients with chronic ankle instability 2022-04-21 anticipated 24 Complete https://irct.ir/trial/62570 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study has a progressive balance training program protocol with and without medial wedge for patients with chronic ankle instability, Randomization description: Randomization will be done using random allocation software based on random blocking method with a size of 4 blocks and a 1: 1 allocation ratio, Blinding description: In this study, the outcome assessor is blind, as he or she does not know how subjects are assigned to the groups and what treatment intervention each group receives. N/A chronic ankle instability. Intervention 1: Intervention group:The intervention group receives progressive balance training with insole with 4 degree medial wedge at rear foot for twelve sessions every other day for four weeks (3 sessions of intervention per week). The insole used in this research is semi-rigid. The superficial layer of insole is made of artificial leather with a thickness of one millimeter, the bottom layer of insole is made of cow leather with a thickness of three millimeter and the medial wedge is made of hard plastic (polyethylene). Intervention 2: Control group: The control group received progressive balance training for twelve sessions every other day for four weeks (3 intervention sessions per week). 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 no more information
public Makan Piri
No. 9, West Arghavan Dead End, Arash Alley, Boostan avenue, Emam Khomeini Blvd, Mehrshahr, Karaj
karaj Iran (Islamic Republic of) 3186619144 +98 26 3332 1098 makanpiri77@gmail.com Tehran University of Medical Sciences scientific Dr Kazem Malmir
Department of Physiotherapy, School of Rehabilitation, Pich Shemiran, Enghelab St, Tehran
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 kmalmir@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with chronic ankle instability; 20- 40 yrs. Normal range of motion in trunk and lower extremity joints Patient has a history of at least one lateral ankle sprain was associated with inflammatory symptoms like pain or swelling and created at least one day interruption of physical activity The initial sprain must have occurred at least 12 months prior to study enrollment The patient has experienced frequent ankle joint giving way (at least twice in the 6 months prior to this study) Cumberland Ankle Instability Tool: score of ≤ 25 Foot and Ankle Ability Measure: activities of daily living subscale <90%, sport subscale <80% 20 years 40 years Both Mechanical ankle instability Flat foot and any structural deformity in lower limb or spine (Medium and severe flat foot are exclude from the study) Cardio-pulmonary disease, head trauma, numbness of the limbs, dizziness and headache The subject has received an ankle rehabilitation program in the last 6 weeks History of the visual, hearing and somatosensory problem can affect the balance History of lower extremity injury or lower-extremity surgery M25.37 Other instability, ankle and foot Rehabilitation Rehabilitation Intervention group:The intervention group receives progressive balance training with insole with 4 degree medial wedge at rear foot for twelve sessions every other day for four weeks (3 sessions of intervention per week). The insole used in this research is semi-rigid. The superficial layer of insole is made of artificial leather with a thickness of one millimeter, the bottom layer of insole is made of cow leather with a thickness of three millimeter and the medial wedge is made of hard plastic (polyethylene). Control group: The control group received progressive balance training for twelve sessions every other day for four weeks (3 intervention sessions per week). Static postural control by measuring the center of pressure parameters. Timepoint: Before the intervention, after the end of 3 sessions of the intervention, after the end of the 12 sessions of the intervention. Method of measurement: Force plate and insert in formula. Dynamic postural control by measuring the reaching distance in the Y balance test. Timepoint: Before the intervention, after the completion of 12 intervention sessions. Method of measurement: Tape and insert in the formula. Symmetry limb index. Timepoint: Before the intervention, after the completion of 12 intervention sessions. Method of measurement: Tape and insert in the formula. Duration of maintenance in the single-leg squat test. Timepoint: Before the intervention, after the completion of 12 intervention sessions. Method of measurement: Stopwatch. Tehran University of Medical Sciences Approved 2022-03-14 Ethics committee of Tehran University of Medical Sciences Department of Physiotherapy, School of Rehabilitation, Pich Shemiran, Enghelab St, Tehran Tehran Tehran Iran (Islamic Republic of)