Effects of SMART VS FIRE Training in Chronic Ankle Instability

April 30, 2024 updated by: Sehat Medical Complex

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Sheikhupura, Punjab, Pakistan
        • Sports Club Sheikhupura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: warm up exercises with SMART training
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. 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.
Other: SMART TRAINING
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
Active Comparator: Group B: Warm up exercises with foot intensive rehabilitation(FIRE)
The FIRE intervention was included 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 target the IFMs including the short-foot, toe-spread-out, hallux extension, and lesser-toe extension.
Other: FIRE training
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from Baseline at 3 weeks and 6 weeks
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
Change from Baseline at 3 weeks and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sehat Medical Complex

Investigators

  • Principal Investigator: wajeeha konain, MSPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • REC/RCRS/1021 Wajeeha

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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