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NCT Number: NCT06149052

Effects of SMART VS FIRE Training in Chronic Ankle Instability

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

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Key information

Conditions

Chronic Ankle Instability

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sports Club Sheikhupura

Sheikhupura, Punjab Province, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMART TRAINING

Other

Patients in Group A received SMART training intervention. For sensory stimulation planter massage was given, and it was applied to entire planter surface. Grade III anterior to posterior talocrural joint mobilization was given (26). For balance, single and double leg stance was performed. For functional training, lateral hops and SEBT was performed. And at the end, for resistance training, theraband was 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 was held per week each lasting approximately 45 - 60 min, including 10 min warm up

FIRE training

Other

Patients in Group B was received foot intensive rehabilitation (FIRE).The FIRE intervention was include the progressive balance training, ankle and hip strengthening, range of motion exercises and foot massage. Plantar massage consisted of two, 1-min plantar massages with a 1-min rest between sets. Four previously established exercises were targeted the IFMs including the short-foot, toe-spread-out, hallux extension, and lesser-toe extension

Primary outcomes

  1. Cumberland Ankle Instability Tool (CAIT)

    Time frame: Change from Baseline at 3 weeks and 6 weeks

    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

  2. Foot and Ankle Ability Measurement (FAAM)

    Time frame: Change from Baseline at 3 weeks and 6 weeks

    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

Sponsors and collaborators

Lead sponsor

Sehat Medical Complex

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2023
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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