Clinical trial NCT06678503: Core Stability Traning Exercises in Chronic Ankle Instability in Atheletes
Official title: ADDING CORE STABILITY EXERCISES TO CONVENTIONAL PROGRAM IN ATHLETES WITH CHRONIC ANKLE INSTABILITY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Ankle Instability and Balance
Keywords: Core stability Balance CAI Atheletes
Lead sponsor: Pharos University in Alexandria
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effect of adding Core stability exercise to the conventional Program of Chronic ankle instability on balance, Functional instability, and Performance in athletes with CAI

Detailed description: Chronic Ankle Instability (CAI) is a prevalent and debilitating condition that afflicts a considerable portion of the population (Al Adal et al.,2020) it is a condition characterized by repetitive episodes or perceptions of the ankle giving way; ongoing symptoms such as pain, weakness, or reduced ankle range of motion (ROM); diminished self-reported function; and recurrent ankle sprains that persist for more than 1 year after the initial injury (Gribble et al.,2013).

Purpose of the Study To study the effect of adding Core stability exercise to the conventional Program of Chronic ankle instability on balance, Functional instability, and Performance in athletes with CAI Methods:Triple Blinded RCT (Blinded: Participants, Research Assistant (for assessment of patient pre- and post-intervention) and statistician) Results :An unpaired t-test will be conducted for comparison of age, weight, and height between groups.

* Chi-squared test will be conducted for comparison of sex distribution between groups
* Mixed MANOVA will be conducted to compare the effect of time (pre versus post) and the effect of treatment (between groups), as well as the interaction between time and treatment on dependent variables.
* The level of significance for all statistical tests will be set at p \< 0.05.
* All statistical measures will be performed through the statistical package for social sciences (SPSS) version 25 for Windows.

Eligibility criteria: Inclusion Criteria:

* Athletes having a history of chronic lateral ankle sprain during the offseason period.

  2. Patients aged between 19-30 years, with BMI ranging between (18.5-29.5kg/m2).

  3. Patients having unilateral CAI with the diagnosis to be based on the criteria described by the International Ankle Consortium for enrolling patients of CAI in controlled research (Gribble et al., 2014) as follows:
  1. A history of at least one significant ankle sprain (the initial sprain must have occurred at least more than 3 months prior to study enrollment, at least one interrupted day of desired physical activity.
  2. Participants should report at least 2 episodes of giving way and/or recurrent sprain and/or feelings of instability in the 6 months prior to study enrollment.
  3. Self-reported ankle instability should be confirmed using a validated ankle instability questionnaire, CAIT\>24.

     Exclusion Criteria:
* Those with a history of spine, pelvis, and lower extremity injury, fracture, or surgery.

  2- Those with LBP that required medical or surgical intervention. 3- Those who participated in supervised or unsupervised ankle rehabilitation within 3 months before enrollment in the study.

  4- Having a history of an acute lower extremity injury in the 3 months before the study.

  5. Participation in formal rehabilitation in the 3 months before the study. 6. Having a history of lower extremity surgery or fracture that required alignment in the involved limb.

  7. Being diagnosed with neurologic dysfunction, such as multiple sclerosis, Parkinson's disease, or head injury.

Primary outcomes:
measure: Star Excursion Balance test
timeFrame: 4 weeks
Secondary outcomes:
measure: Functional Instability
timeFrame: 4 weeks
measure: Functional Performance
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Enas Fawzy Yousef, Professor
role: STUDY_CHAIR
affiliation: Cairo University
name: Tarek Saad, Associate Professor
role: STUDY_DIRECTOR
affiliation: Pharos University in Alexandria
name: Aya Ahmed Nada, PHD
role: STUDY_DIRECTOR
References:
citation: Huang PY, Chen WL, Lin CF, Lee HJ. Lower extremity biomechanics in athletes with ankle instability after a 6-week integrated training program. J Athl Train. 2014 Mar-Apr;49(2):163-72. doi: 10.4085/1062-6050-49.2.10. Epub 2014 Feb 25.
citation: Herzog MM, Kerr ZY, Marshall SW, Wikstrom EA. Epidemiology of Ankle Sprains and Chronic Ankle Instability. J Athl Train. 2019 Jun;54(6):603-610. doi: 10.4085/1062-6050-447-17. Epub 2019 May 28.
citation: Hale SA, Fergus A, Axmacher R, Kiser K. Bilateral improvements in lower extremity function after unilateral balance training in individuals with chronic ankle instability. J Athl Train. 2014 Mar-Apr;49(2):181-91. doi: 10.4085/1062-6050-49.2.06. Epub 2014 Feb 25.
citation: Hall EA, Chomistek AK, Kingma JJ, Docherty CL. Balance- and Strength-Training Protocols to Improve Chronic Ankle Instability Deficits, Part I: Assessing Clinical Outcome Measures. J Athl Train. 2018 Jun;53(6):568-577. doi: 10.4085/1062-6050-385-16. Epub 2018 Jul 5.
citation: Hiller CE, Nightingale EJ, Raymond J, Kilbreath SL, Burns J, Black DA, Refshauge KM. Prevalence and impact of chronic musculoskeletal ankle disorders in the community. Arch Phys Med Rehabil. 2012 Oct;93(10):1801-7. doi: 10.1016/j.apmr.2012.04.023. Epub 2012 May 7.