Chronic Ankle Instability and BalanceNCT06678503
Core Stability Traning Exercises in Chronic Ankle Instability in Atheletes
A study testing balance exercise and Core stability exercises in people with Chronic Ankle Instability and Balance, run by Pharos University in Alexandria.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability and Balance
- What is being tested?
- balance exercise and Core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ADDING CORE STABILITY EXERCISES TO CONVENTIONAL PROGRAM IN ATHLETES WITH CHRONIC ANKLE INSTABILITY
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
Read the 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.
- Conditions
- Chronic Ankle Instability and Balance
- Being tested
- balance exercise, Core stability exercises
- Keywords
- Core stability Balance CAI Atheletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance exerciseOther
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).
Core stability exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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: Receives: 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 Receives: Other: balance exercise; Other: Core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (2)
Functional Instability
The Cumberland Ankle Instability Tool assesses ankle instability during activities of daily living and sports and is valid and reliable for determining the presence of CAI
Measured: 4 weeks
Functional Performance
Functional performance tests are dynamic measures used to assess general lower body function. These tests are helpful because they combine multiple components, such as muscular strength, neuromuscular coordination, and joint stability, which could be affected after joint injury.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle Instability and BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abanoub malak latif, Pharos University in Alexandria
- Investigators
- Enas Fawzy Yousef, Professor, Study chair, Cairo UniversityTarek Saad, Associate Professor, Study director, Cairo UniversityAya Ahmed Nada, PHD, Study director, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678503
- Sponsor's protocol ID
- P.T.REC/012/005346
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24568224Herzog 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.
PubMed 31135209Hale 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.
PubMed 24568231Hall 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.
PubMed 29975573Hiller 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.
PubMed 22575395
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADDING CORE STABILITY EXERCISES TO CONVENTIONAL PROGRAM IN ATHLETES WITH CHRONIC ANKLE INSTABILITY
- ClinicalTrials.gov ID
- NCT06678503
- Acronym / sponsor ID
- P.T.REC/012/005346
- Conditions
- Chronic Ankle Instability and Balance
- Keywords
- Core stability Balance CAI Atheletes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: balance exercise1. 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: |
| Experimental Group | Experimental | Other: balance exercise, Other: Core stability exercisesParticipants 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 |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balance exerciseBalance 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). | Other | Control Group, Experimental Group |
| Core stability exercisesCore 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. | Other | Experimental Group |
Primary outcome
Star Excursion Balance test
Time frame: 4 weeks
is a reliable functional test to evaluate dynamic postural control of the lower limb and distinguish CAI from copers and healthy individuals
2 secondary outcomes
Functional Instability
Time frame: 4 weeks
Functional Performance
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Background: PubMed 24568224Huang 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.
- Results publication: PubMed 31135209Herzog 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.
- Results publication: PubMed 24568231Hale 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.
- Results publication: PubMed 29975573Hall 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.
- Results publication: PubMed 22575395Hiller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enas Fawzy Yousef, Professor study chair
Cairo University
Tarek Saad, Associate Professor study director
Cairo University
Aya Ahmed Nada, PHD study director
Pharos University in Alexandria
Questions about this trial
What is this clinical trial studying?
A study testing balance exercise and Core stability exercises in people with Chronic Ankle Instability and Balance, run by Pharos University in Alexandria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Ahme Nada, PHD (01285859034, Aya.ahmed@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Star Excursion Balance test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06678503, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.