Instability, JointNCT07731035
Effect of Core Stability Training With Foot Exercises in Chronic Ankle Instability Patients
A study testing conventional physical therapy, Core stability training and intrinsic foot muscle exercises in people with Instability, Joint, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to investigate the effects of various treatments on lumbar and ankle proprioception, balance, and foot function in patients with chronic ankle instability. The objectives include assessing the combined effects of core stability training and intrinsic foot muscle exercises with conventional therapy, the… Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Instability, Joint
- What is being tested?
- conventional physical therapy, Core stability training and intrinsic foot muscle exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to 1 Sep 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 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects will be selected from the outpatient clinic of Delta University hospital, Dakahlia, Egypt. 2. Both male \& female genders aged between 18 and 44 years. 3. Participants should have a history of at least one significant ankle sprain; the initial sprain must have occurred at least 12 months prior to the study enrolment and was associated with inflammatory symptoms (pain, swelling) 4. Patients having Scores on the Cumberland ankle instability tool of 24 or below 5. Participants should report at least 2 episodes of 'giving way' in the 6 months prior to the study enrolment. Episodes of giving way will be described as an incident in which the rearfoot suddenly rolled, felt weak, or lost stability; however, the individual did not sustain an ankle sprain and will have been able to continue with normal function after the incident 6. Body mass index for all groups will be ranged from 18.8-29 kg/m²
Who cannot join
- history of lower extremity surgery, lower extremity fractures, and immobilization of foot or ankle for 48 hr or longer within the previous 6 months
- Conditions other than ankle sprain that affect balance or they are receiving ankle rehabilitation at the time of screening.
- Acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
out-patient clinic, faculty of physical therapy, Delta university
Al Mansurah
Asmaa Abdelnaser Atia Saad, physical therapist, 01024728414, asmaa.naser56@gmail.com
About this study
Official title: Effect of Core Stability Training With Foot Exercises on Proprioception, Balance and Foot Function in Chronic Ankle Instability Patients
This study aims to investigate the effects of various treatments on lumbar and ankle proprioception, balance, and foot function in patients with chronic ankle instability. The objectives include assessing the combined effects of core stability training and intrinsic foot muscle exercises with conventional therapy, the impact of core stability training alone, the effects of intrinsic foot muscle exercises in conjunction with conventional treatment, and the outcomes of conventional therapy alone. Additionally, the study will compare the effectiveness of these different treatment protocols.
Read the detailed description
Chronic ankle instability (CAI) is characterized by both mechanical and functional ankle joint instability, with various contributing factors persisting post-healing after an acute sprain. Recent studies emphasize that chronic ankle instability is a complex condition necessitating interdisciplinary research. Effective treatment requires multimodal protocols, integrating core stability training and intrinsic foot muscle exercises. Core stability enhances proximal neuromuscular control, while intrinsic exercises improve distal stability and foot function. This combined approach aims to improve lumbar and ankle proprioception, balance, and postural control, ultimately reducing recurrent injuries. Results will provide valuable insights to develop evidence-based rehabilitation programs addressing both proximal and distal factors in chronic ankle instability, enhancing understanding of sensorimotor control and rehabilitation strategies.
- Conditions
- Instability, Joint
- Being tested
- conventional physical therapy, Core stability training, intrinsic foot muscle exercises
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapyOther
Stretching the gastrocnemius and soleus muscle (30 s) of three repetitions, three sets of strengthening exercises of ankle musculature, using Thera Band resistance (ten repetitions in each set), and balance training exercises: First, standing on one leg with eyes open, later will be progressed to eyes closed with 60 s hold for two repetitions will be given along with balance board exercises and double-leg and single-leg stances
Core stability trainingOther
The program is structured in three phases over six weeks. The first phase (1-2 weeks) focuses on abdominal drawing-in maneuvers to activate the transverses abdominis and lumbar multifidus muscles, with participants palpating the contractions for feedback. The second phase (3-4 weeks) integrates coordinated cocontraction of both muscles alongside upper and lower limb movements in various positions such as lying, sitting, standing, and quadruped. The third phase (5-6 weeks) emphasizes core activation during functional activities, including sit-to-stand, wall squats, and lunges, incorporating three sets of ten repetitions while maintaining the final position for 10 seconds in each exercise.
intrinsic foot muscle exercisesOther
In this program, participants will engage in four exercises targeting the intrinsic foot muscles (IFMs): short-foot exercise, toe spread out, hallux extension, and lesser-toe extension. For the first two weeks, exercises will be done while sitting; during weeks three and four, they will shift to standing; and in weeks five and six, the exercises will be performed while standing on one leg.
| Study group | Role | What they receive |
|---|---|---|
| conventional physical therapy | Active comparator | Involves twenty patients who will receive conventional physical therapy treatment 18 sessions of exercises, 3 sessions per week for 6 weeks. Receives: Other: conventional physical therapy |
| core stability training | Experimental | Involves twenty patients who will receive core stability training in addition to conventional physical therapy treatment: 18 sessions of exercises, 3 sessions per week for 6 weeks. Receives: Other: conventional physical therapy; Other: Core stability training |
| intrinsic foot muscle exercises | Experimental | Involves twenty patients who will receive intrinsic foot muscle exercises in addition to conventional physical therapy treatment: 18 sessions of exercises, 3 sessions per week for 6 weeks. Receives: Other: conventional physical therapy; Other: intrinsic foot muscle exercises |
| Core Stability with Foot Exercises | Experimental | Involves twenty patients who will receive core stability training core stability training accompanied with intrinsic foot muscle exercises in addition to conventional physical therapy treatment 18 sessions of exercises, 3 sessions per week for 6 weeks. Receives: Other: conventional physical therapy; Other: Core stability training; Other: intrinsic foot muscle exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of balance
The study employs the Biodex Balance System to assess dynamic control using the Limits of Stability test. This test measures the maximum angle from vertical that an individual can achieve without losing balance, with normal limits of stability parameters set at eight degrees anterior, four degrees posterior, and 16 degrees laterally. Participants perform the test, aiming to shift their weight toward blinking targets on a screen while avoiding handrail support unless necessary. Two trials per participant are conducted, with results detailing test duration and overall performance percentage, where a score of 100% indicates precise movement towards targets.
Measured: At baseline and after 6 weeks
Secondary outcomes (3)
assessment of Lumbar proprioception
The study assesses lumbar position sense using an iPhone inclinometer. Joint repositioning methods, active and passive, evaluate this sense based on absolute error, which indicates the discrepancy between target and actual angles; lower absolute error reflects better joint position sense. The inclinometer was positioned between specific anatomical landmarks, fixed at 0°, during a 0 to 30° range of motion test. Participants held a 30° flexion posture for ten seconds before returning to the starting position, with three repetitions performed. Eye masks were used to eliminate visual cues, and average measurements were recorded after appropriate rest intervals. The proprioceptive error was determined as absolute angular error, reflecting the deviation from the reference angle.
Measured: At baseline and after 6 weeks
assessment of Ankle proprioception:
Measurements of ankle proprioception were conducted using a Baseline digital inclinometer in a controlled environment with participants in a sitting position. The study assessed proprioception through active reproduction tests in both eyes open and closed conditions at specified dorsiflexion and plantar flexion angles. Participants were instructed to memorize a target angle for 10 seconds before returning to the initial position and actively or passively reproducing the angle. Deviations from the target angle, recorded as angular errors, were averaged over three trials to obtain mean values.
Measured: At baseline and after 6 weeks
assessment of foot function
The assessment will utilize the Arabic version of the Foot and Ankle Ability Measure questionnaire. it is a patient-reported outcome tool designed to evaluate functionality in patients with leg, ankle, or foot disorders, focusing on daily living and sports-related activities. It comprises subscales for daily living (21 items) and sports (8 items), scored on a 5-point Likert scale. Final scores reflect self-reported function as a percentage, with lower scores indicating reduced functionality. it has proven reliability (Activities of Daily Living interclass correlation=0.89; Sport interclass correlation=0.87) and responsiveness in tracking patient progress, with minimal detectable changes of ±5.7 for daily living and ±12.3 points for the sport subscale.
Measured: At baseline and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 May 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instability, JointStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdelnaser Atia Saad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731035
- Sponsor's protocol ID
- Asmaa_Msc
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Stability Training With Foot Exercises on Proprioception, Balance and Foot Function in Chronic Ankle Instability Patients
- ClinicalTrials.gov ID
- NCT07731035
- Acronym / sponsor ID
- Asmaa_Msc
- Conditions
- Instability, Joint
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 28 Jul 2026 (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.
This study aims to investigate the effects of various treatments on lumbar and ankle proprioception, balance, and foot function in patients with chronic ankle instability. The objectives include assessing the combined effects of core stability training and intrinsic foot muscle exercises with conventional therapy, the impact of core stability training alone, the effects of intrinsic foot muscle exercises in conjunction with conventional treatment, and the outcomes of conventional therapy alone. Additionally, the study will compare the effectiveness of these different treatment protocols.
Detailed description
Chronic ankle instability (CAI) is characterized by both mechanical and functional ankle joint instability, with various contributing factors persisting post-healing after an acute sprain. Recent studies emphasize that chronic ankle instability is a complex condition necessitating interdisciplinary research. Effective treatment requires multimodal protocols, integrating core stability training and intrinsic foot muscle exercises. Core stability enhances proximal neuromuscular control, while intrinsic exercises improve distal stability and foot function. This combined approach aims to improve lumbar and ankle proprioception, balance, and postural control, ultimately reducing recurrent injuries. Results will provide valuable insights to develop evidence-based rehabilitation programs addressing both proximal and distal factors in chronic ankle instability, enhancing understanding of sensorimotor control and rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| conventional physical therapy | Active comparator | Other: conventional physical therapyInvolves twenty patients who will receive conventional physical therapy treatment 18 sessions of exercises, 3 sessions per week for 6 weeks. |
| core stability training | Experimental | Other: conventional physical therapy, Other: Core stability trainingInvolves twenty patients who will receive core stability training in addition to conventional physical therapy treatment: 18 sessions of exercises, 3 sessions per week for 6 weeks. |
| intrinsic foot muscle exercises | Experimental | Other: conventional physical therapy, Other: intrinsic foot muscle exercisesInvolves twenty patients who will receive intrinsic foot muscle exercises in addition to conventional physical therapy treatment: 18 sessions of exercises, 3 sessions per week for 6 weeks. |
| Core Stability with Foot Exercises | Experimental | Other: conventional physical therapy, Other: Core stability training, Other: intrinsic foot muscle exercisesInvolves twenty patients who will receive core stability training core stability training accompanied with intrinsic foot muscle exercises in addition to conventional physical therapy treatment 18 sessions of exercises, 3 sessions per week for 6 weeks. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects will be selected from the outpatient clinic of Delta University hospital, Dakahlia, Egypt. 2. Both male \& female genders aged between 18 and 44 years. 3. Participants should have a history of at least one significant ankle sprain; the initial sprain must have occurred at least 12 months prior to the study enrolment and was associated with inflammatory symptoms (pain, swelling) 4. Patients having Scores on the Cumberland ankle instability tool of 24 or below 5. Participants should report at least 2 episodes of 'giving way' in the 6 months prior to the study enrolment. Episodes of giving way will be described as an incident in which the rearfoot suddenly rolled, felt weak, or lost stability; however, the individual did not sustain an ankle sprain and will have been able to continue with normal function after the incident 6. Body mass index for all groups will be ranged from 18.8-29 kg/m²
Key exclusion criteria (3 listed)
- history of lower extremity surgery, lower extremity fractures, and immobilization of foot or ankle for 48 hr or longer within the previous 6 months
- Conditions other than ankle sprain that affect balance or they are receiving ankle rehabilitation at the time of screening.
- Acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
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 |
|---|---|---|
| conventional physical therapyStretching the gastrocnemius and soleus muscle (30 s) of three repetitions, three sets of strengthening exercises of ankle musculature, using Thera Band resistance (ten repetitions in each set), and balance training exercises: First, standing on one leg with eyes open, later will be progressed to eyes closed with 60 s hold for two repetitions will be given along with balance board exercises and double-leg and single-leg stances | Other | Core Stability with Foot Exercises, conventional physical therapy, core stability training, intrinsic foot muscle exercises |
| Core stability trainingThe program is structured in three phases over six weeks. The first phase (1-2 weeks) focuses on abdominal drawing-in maneuvers to activate the transverses abdominis and lumbar multifidus muscles, with participants palpating the contractions for feedback. The second phase (3-4 weeks) integrates coordinated cocontraction of both muscles alongside upper and lower limb movements in various positions such as lying, sitting, standing, and quadruped. The third phase (5-6 weeks) emphasizes core activation during functional activities, including sit-to-stand, wall squats, and lunges, incorporating three sets of ten repetitions while maintaining the final position for 10 seconds in each exercise. | Other | Core Stability with Foot Exercises, core stability training |
| intrinsic foot muscle exercisesIn this program, participants will engage in four exercises targeting the intrinsic foot muscles (IFMs): short-foot exercise, toe spread out, hallux extension, and lesser-toe extension. For the first two weeks, exercises will be done while sitting; during weeks three and four, they will shift to standing; and in weeks five and six, the exercises will be performed while standing on one leg. | Other | Core Stability with Foot Exercises, intrinsic foot muscle exercises |
Primary outcome
Assessment of balance
Time frame: At baseline and after 6 weeks
The study employs the Biodex Balance System to assess dynamic control using the Limits of Stability test. This test measures the maximum angle from vertical that an individual can achieve without losing balance, with normal limits of stability parameters set at eight degrees anterior, four degrees posterior, and 16 degrees laterally. Participants perform the test, aiming to shift their weight toward blinking targets on a screen while avoiding handrail support unless necessary. Two trials per participant are conducted, with results detailing test duration and overall performance percentage, where a score of 100% indicates precise movement towards targets.
3 secondary outcomes
assessment of Lumbar proprioception
Time frame: At baseline and after 6 weeks
assessment of Ankle proprioception:
Time frame: At baseline and after 6 weeks
assessment of foot function
Time frame: At baseline and after 6 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 28 Jul 2026.
Related trials for Instability, Joint
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruitingObservational study
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Osteoarthritis, Knee, Arthritis, Rheumatoid
RecruitingObservational study
A Study on Associations Between Multidimensional Human Phenotypic Traits and Human Growth and Development
Musculoskeletal Growth and Development
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physical therapy, Core stability training and intrinsic foot muscle exercises in people with Instability, Joint, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Asmaa Abdelnaser Atia Saad, physical therapist (01024728414, asmaa.naser56@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of balance (time frame: At baseline and after 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.