Effects of SMART VS FIRE Training in Chronic Ankle Instability

Study Overview
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Brief Summary
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The study will be a randomized clinical trial with the sample size of 26. The study will be conducted at Sports Club Sheikhupura. Subjects will be enrolled according to eligibility criteria. Patients will be divided into two groups, each with 13 patients. Group A will receive SMART training intervention and warm-up exercises, while group B will receive Foot intensive rehabilitation exercises (FIRE) and warm up exercises. The session will be around 45 to 60 min on each patient with three sessions per week on alternate days. A total of Three weeks treatment regime will be given to the patients and assessment of patient's strength (CAIT) and performance (FAAM) will be done at the baseline, after the completion of treatment at three weeks and after six weeks to observe the long-term effects.

Detailed Description
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Ankle sprain is one of the most common sports injuries in physically active individuals and causes a high financial burden on the healthcare system. Seventy-four percent of patients with an acute ankle sprain suffered from residual symptoms lasting 29 months after the initial ankle sprain, such as pain, perceived instability, weakness and swelling. Lateral ankle sprains (LASs) are a common injury sustained by individuals who participate in recreational physical activities and sports. After LAS, a large proportion of individuals develop long-term symptoms, which contribute to the development of chronic ankle instability (CAI).The aim of this study to determine the comparative effects of SMART training intervention versus foot intensive rehabilitation (FIRE) on strength and performance in athletes with chronic ankle instability. The study will be a randomized clinical trial with the sample size of 26. The study will be conducted at Sports Club Sheikhupura. Subjects will be enrolled according to eligibility criteria. Patients will be divided into two groups, each with 13 patients. Group A will receive SMART training intervention and warm-up exercises, while group B will receive Foot intensive rehabilitation exercises (FIRE) and warm up exercises. The session will be around 45 to 60 min on each patient with three sessions per week on alternate days. A total of Three weeks treatment regime will be given to the patients and assessment of patient's strength (CAIT) and performance (FAAM) will be done at the baseline, after the completion of treatment at three weeks and after six weeks to observe the long-term effects.

Official Title
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Effects of SMART Training Intervention Versus Foot Intensive Rehabilitation (FIRE) on Strength and Performance in Athletes With Chronic Ankle Instability

Conditions
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Chronic Ankle Instability

Intervention / Treatment
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* Other: SMART TRAINING
* Other: FIRE training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Athletes 18-45 years of age, 2 repeated episodes of giving way, feelings of instability Core training not less than 4 week. Chronic ankle instability more than 6 months. Repeated ankle sprain more than twice and patients with <24 points based on CAIT. Athletes with single side ankle instability Exclusion Criteria: Acute concomitant injuries of the ankle. Individuals who were able to return to pre-injury levels of activity Serious lower-extremity injuries of the last 6 months Lower-extremity surgery, and neurological diseases Simultaneous severe sprain of both ankle joints

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: warm up exercises with SMART training<br>For sensory stimulation planter massage will be given, and it will be applied to entire planter surface. Grade III anterior to posterior talocrural joint mobilization will be given. For balance, single and double leg stance will be performed. For functional training, lateral hops and SEBT will be performed. And at the end, for resistance training, theraband will be used with normal ankle joint movement. There is a progress in focus between the five domains over the 3weeks, as described below: The domains S and M are present across the whole intervention. In week 1, the main focus is on the A domain, in week 2 on the R domain, and in week 3 on the T domain. During the 3-week intervention period, 3 training sessions will be held per week each lasting approximately 45 - 60 min, including 10 min warm up. | Other: SMART TRAINING<br>* Patients in Group A will receive SMART training intervention. For sensory stimulation planter massage will be given, and it will be applied to entire planter surface. Grade III anterior to posterior talocrural joint mobilization will be given (26). For balance, single and double leg stance will be performed. For functional training, lateral hops and SEBT will be performed. And at the end, for resistance training, theraband will be used with normal ankle joint movement. There is a progress in focus between the five domains over the 3weeks, as described below: The domains S and M are present across the whole intervention. In week 1, the main focus is on the A domain, in week 2 on the R domain, and in week 3 on the T domain. During the 3-week intervention period, 3 training sessions will be held per week each lasting approximately 45 - 60 min, including 10 min warm up<br>|
| Active Comparator: Group B: Warm up exercises with foot intensive rehabilitation(FIRE)<br>The FIRE intervention will include the progressive balance training, ankle and hip strengthening, range of motion exercises and foot massage. Plantar massage will consist of two, 1-min plantar massages with a 1-min rest between sets. Four previously established exercises will target the IFMs including the short-foot, toe-spread-out, hallux extension, and lesser-toe extension. | Other: FIRE training<br>* Patients in Group B will receive foot intensive rehabilitation (FIRE).The FIRE intervention will include the progressive balance training, ankle and hip strengthening, range of motion exercises and foot massage. Plantar massage will consist of two, 1-min plantar massages with a 1-min rest between sets. Four previously established exercises will target the IFMs including the short-foot, toe-spread-out, hallux extension, and lesser-toe extension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumberland Ankle Instability Tool (CAIT) | Cumberland Ankle Instability Tool (CAIT) was originally developed in English and proved to be of high content validity and good reliability. The main advantage of the questionnaire is that it consists of only 9 items, minimizing patient burden and increasing reliability. The precision of the instrument is increased as it is a multiple answer option instrument | Change from Baseline at 3 weeks and 6 weeks | 
| Foot and Ankle Ability Measurement (FAAM) | The Foot and Ankle Ability Measure (FAAM) assess the functional limitation of the foot and ankle. The FAAM has 29 items, scored between 0 and 4, divided into two sub-scales: activities of daily living (21 items) and sports (8 items)(24).For score analysis, the percentage of each sub scale is used separately. For FAAM ADL, person reliability is 0.87 and item reliability is0.99. For FAAM Sport, person reliability is 0.89 and item reliability is 1.0 | Change from Baseline at 3 weeks and 6 weeks |