NCT06678503

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Dec 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Dec 2024Jun 2026

First Submitted

Initial submission to the registry

November 6, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 6, 2024

Last Update Submit

November 10, 2024

Conditions

Keywords

Core stability Balance CAI Atheletes

Outcome Measures

Primary Outcomes (1)

  • Star Excursion Balance test

    is a reliable functional test to evaluate dynamic postural control of the lower limb and distinguish CAI from copers and healthy individuals

    4 weeks

Secondary Outcomes (2)

  • Functional Instability

    4 weeks

  • Functional Performance

    4 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

1. Single legged stance: 2. Single-legged stance on the balance board 3. Single legged hop 4. Quadrant Hop: 5. Single legged Ball Catch: 6. Hop ups and downs:

Other: balance exercise

Experimental Group

EXPERIMENTAL

Participants Will perform the same exercises in addition to core exercises The core exercises will include 12 different exercises: Week 1 : 1. Abdominal Drawing In 2. Abdominal Drawing in with alternating lower limb movement 3. Pelvic tilting with standing 4. Forward lunge Week 2 : 1. Bracing with bridging 2. Curl up with bracing 3. Quadruped with bracing 4. Side plank with knee flexed Week 3 : 1. Bracing with straight leg raising 2. Quadruped leg lift with bracing 3. Bridging with bracing on a Swiss ball 4. Side plank with the knee extended Week 4 : 1. Alternate arm and leg raise from quadruped 2. Abdominal drawing in with a squat against a wall 3. Single limb deadlift 4. Squat with overhead sustained lift

Other: balance exerciseOther: Core stability exercises

Interventions

Balance exercises are physical activities designed to improve stability, coordination, and posture by challenging the body's ability to maintain an upright position. These exercises target the muscles and systems involved in balance, particularly the core, legs, and the sensory systems (like vision and proprioception).

Control GroupExperimental Group

Core stability exercises are physical activities designed to improve the strength, endurance, and coordination of the muscles that support and stabilize the spine, pelvis, and torso. These exercises specifically target the muscles of the abdomen, lower back, hips, and pelvis, collectively referred to as the "core." The goal is to enhance overall posture, prevent injury, and improve performance in daily activities or sports by increasing the body's ability to stabilize itself during movement.

Experimental Group

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Athletes having a history of chronic lateral ankle sprain during the offseason period.
  • \. Patients aged between 19-30 years, with BMI ranging between (18.5-29.5kg/m2).
  • \. 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:
  • 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.
  • 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.
  • Self-reported ankle instability should be confirmed using a validated ankle instability questionnaire, CAIT\>24.

You may not qualify if:

  • Those with a history of spine, pelvis, and lower extremity injury, fracture, or surgery.
  • 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.
  • Having a history of an acute lower extremity injury in the 3 months before the study.
  • \. 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.
  • \. Being diagnosed with neurologic dysfunction, such as multiple sclerosis, Parkinson's disease, or head injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 24568224BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Enas Fawzy Yousef, Professor

    Cairo University

    STUDY CHAIR
  • Tarek Saad, Associate Professor

    Cairo University

    STUDY DIRECTOR
  • Aya Ahmed Nada, PHD

    Pharos University in Alexandria

    STUDY DIRECTOR

Central Study Contacts

Aya Ahme Nada, PHD

CONTACT

Abanoub Malak Khalifa, Demonstrator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Triple ( Participant, Care provider, outcomes Assessor )
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical therapist

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 7, 2024

Study Start

December 1, 2024

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

November 13, 2024

Record last verified: 2024-11