Cognitive TrainingNCT07283276
Effect of Functional Core Stability Training or Cognitive Training on Balance and Postural Control in Chronic Ankle Instability
A study testing strengthening exercises, Balance training and Functional core training in people with Cognitive Training and Functional Core Stability Training, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to investigate dynamic core stability training versus cognitive training on balance, functional performance, postural control, ankle instability scores, ankle dorsiflexion range of motion, and mental workload in chronic ankle instability Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Cognitive Training, Functional Core Stability Training, Balance; Distorted
- What is being tested?
- strengthening exercises, Balance training and Functional core training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2025to 1 Mar 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion criteria will be based on the standard criteria outlined by the International Ankle Consortium
- History of chronic lateral ankle sprain and/or recurrent sprain and/or "feelings of instability or giving way" for 6 months or more before the study, with at least 2 episodes.
- Patients are between 18 and 30 years old. 3- Body mass index less than 30
- 4. The patient has a history of at least one significant ankle sprain with associated inflammatory symptoms and at least one day of interrupted physical activity.
- 5. Patients who have unilateral chronic ankle instability. 6. Self-reported ankle instability should be confirmed using a validated ankle instability questionnaire (greater than 24).
Who cannot join
- Those with a history of spine, pelvis, and lower extremity injury, fracture, or surgery 2- Those with low back pain that require medical or surgical intervention. 3- Having a history of an acute lower extremity injury or lower extremity surgery or fracture in the 3 months before the Study 4. Participation in formal ankle rehabilitation in the 3 months before the study.
- 5. Being diagnosed with neurologic dysfunction, such as multiple sclerosis, Parkinson's disease, or head injury
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, Cairo university
Cairo
Manar Mahmoud Mohamed, Assistant lecturer, +20 100 758 7316, manarmahmoud690@gmail.com
About this study
Official title: Effect of Adding Functional Core Stability Training or Cognitive Training on Balance and Postural Control in Rehabilitation of Chronic Ankle Instability
The purpose of the study is to investigate dynamic core stability training versus cognitive training on balance, functional performance, postural control, ankle instability scores, ankle dorsiflexion range of motion, and mental workload in chronic ankle instability
Read the detailed description
Lateral ankle sprains (LAS) are prevalent in sports, with 40% leading to chronic ankle instability (CAI), impacting muscle coordination and balance, primarily controlled by the central nervous system (CNS). Core muscles play a vital role in stabilization and postural control, particularly for individuals with chronic ankle instability, because they significantly contribute to the risk of injury. Even with intact strength and balance, individuals with chronic ankle instability may re-injure when attention shifts, highlighting the need for dual-task training to improve postural control. Core stability training, which includes cognitive elements, has been shown to enhance muscle function and reduce instability. Training programs incorporating dual-task exercises have proven superior for improving joint position sense and postural control while addressing associated mental health issues in chronic ankle instability patients. Therefore, this study aims to analyze the effects of combining dynamic core stability exercises with cognitive training on dual-task conditions, marking a novel approach in chronic ankle instability rehabilitation.
- Conditions
- Cognitive Training, Functional Core Stability Training, Balance; Distorted, Postural Control, Chronic Ankle Instability
- Being tested
- strengthening exercises, Balance training, Functional core training, Spinal motor control (stabilization) exercises, Cognitive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strengthening exercisesOther
Stretch the gastrocnemius and soleus muscles for 30 seconds with 3 repetitions. Strengthen all ankle muscles using TheraBand resistance for various movements (dorsiflexion, plantar flexion, inversion, and eversion) and combined movements for 3 sets of 10 repetitions, three sessions weekly for two months. The training program includes progression from seated to standing for stretching and single-limb for bipedal calf raises.
Balance trainingOther
Challenging disc training, utilized in balance studies, begins with participants standing with slightly bent knees. The dynamic balance training comprises 9 protocols focused on tracking a moving red circular target zone using a green point cursor that represents the center of pressure. Participants shift their body weight in various directions with visual feedback on a computer screen. Over 8 weeks, participants complete 16 sessions, each lasting 20 seconds with 7 seconds of rest in between. The time spent correctly tracking the target is measured and analyzed across all protocols.
Functional core trainingOther
Participants will receive functional core motor control (stabilization) exercise and the traditional program (consisting of stretching protocol, strengthening of all ankle muscles, and balance activities) 3 sessions per week for 2 months.
Spinal motor control (stabilization) exercisesOther
The training program consists of three phases:
- Cognitive Phase (Weeks 1-2): Focuses on isolating the transversus abdominis and multifidus muscles using a biofeedback pressure device. Exercises involve isometric contractions with 10-second holds, repeated four times daily.
- Associative Phase (Weeks 3-4): Introduces less stable exercises (e.g., quadruped and standing positions) aimed at enhancing spine neutrality.
- Automatic Phase (Weeks 5-8): Involves dynamic movements that integrate spine control with extremity movements. Key exercises include lunges with a medicine ball, squats, and various plank variations, emphasizing co-contraction of core muscles for stability during movements.
Cognitive trainingOther
Balance training is combined with a cognitive task involving a backward digit span test, where participants must recall and repeat sequences of numbers in reverse order, testing working memory. This test includes three difficulty levels (3-, 4-, and 5-digit sequences) performed over 35 seconds. Participants will either recall digits while maintaining static stability or after squatting upon hearing a number, with a focus on accuracy within 5 seconds. Performance is measured by the percentage of correctly recalled digits, and error scoring will be documented via video recording for each posture task.
| Study group | Role | What they receive |
|---|---|---|
| core stability | Experimental | they will receive traditional program plus functional core stability exercise Receives: Other: strengthening exercises; Other: Balance training; Other: Functional core training; Other: Spinal motor control (stabilization) exercises |
| cognitive training | Experimental | they will receive traditional program plus cognitive training Receives: Other: strengthening exercises; Other: Balance training; Other: Cognitive training |
| Core stability and cognitive training | Active comparator | they will receive traditional program plus functional core training plus cognitive training Receives: Other: strengthening exercises; Other: Balance training; Other: Functional core training; Other: Spinal motor control (stabilization) exercises; Other: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of change of pain
Ankle pain will be evaluated using the Arabic version of the Cumberland Ankle Instability Tool, which consists of questions that the patient must answer to reflect their condition. The scoring ranges from 0 to 30, with 0 indicating severe instability and 30 indicating normal stability. A score below 24 suggests Chronic Ankle Instability as defined by the International Ankle Consortium
Measured: at baseline and after 2 months
assessment of ankle instability
Ankle instability will be evaluated using the Arabic version of the Cumberland Ankle Instability Tool, which consists of questions that the patient must answer to reflect their condition. The scoring ranges from 0 to 30, with 0 indicating severe instability and 30 indicating normal stability. A score below 24 suggests Chronic Ankle Instability as defined by the International Ankle Consortium
Measured: at baseline and after 2 months
Secondary outcomes (6)
assessment of foot function
Participants will complete a 29-item questionnaire consisting of the Foot and Ankle Ability Measure, which includes a 21-item Activities of Daily Living (ADL) Subscale and an 8-item Sports Subscale. Each item is rated on a 5-point Likert scale from 0 (unable to perform) to 4 (no difficulty), yielding a potential score of 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale. The total score is calculated by subtracting the raw score from the maximum possible score, dividing by the maximum score, and multiplying by 100 to determine the percentage of maximum ability achieved.
Measured: at baseline and after 2 months
assessment of functional performance
The side-hop test involves participants hopping laterally on one limb over a distance of 30 cm for 10 repetitions, with a stopwatch recording the fastest time. Trials are invalidated if the contralateral foot touches the ground. After 1-3 practice trials, 3 test trials are conducted, and the average time is used for analysis (Kamonseki et al., 2018). Additionally, the figure of the hop test requires participants to hop twice around a 5-m cone-marked course as fast as possible, with penalties for footfall or course deviations, and timing recorded to the nearest 0.01 seconds.
Measured: at baseline and after 2 months
assessment of postural control
The modified star test grid features three lines emanating from a center point, oriented as anterior, posteromedial, and posterolateral. Participants stand at the center with feet together and perform single-limb squats, reaching towards maximum points along each direction line with the swinging limb. The participant must lightly touch the line with the distal part of the reaching foot without shifting their weight to it or resting on it. They must then return the limb to the center while maintaining balance on the stance limb. Any heavy contact, resting, or shifting during the trial invalidates it. Maximum reach distances are measured with a tape measure.
Measured: at baseline and after 2 months
assessment of balance
The "Self-check" mode provides two measurement options for Static Balance Testing and alternative assessments using an Electronic Balance Board. Participants stand with feet shoulder-width apart (~30 cm) and are monitored via a computer screen displaying a target zone of five concentric circles. The test includes a 15-second adaptation phase followed by a 20-second measurement period, during which stability is assessed based on how long a tracking ball remains within the inner circle. Scores range from 1 (Excellent Stability) to 5 (Bad Stability), with lower scores indicating better performance. Additionally, dynamic tasks require participants to track a target point on-screen, measuring time in the target for scoring. After the tests, scores for each foot and the overall percentage difference are displayed, with values below 10% indicating good body balance.
Measured: at baseline and after 2 months
assessment of Dorsiflexion range of motion
The inclinometer will be fixed to the lateral side of the distal leg just above the ankle joint using a strap. It should be oriented laterally, and its zero point should be parallel to the floor. Participant will make dorsiflexion from weightbearing position by proximal segment, the degree of changed range from zero will be appeared on inclinometer
Measured: at baseline and after 2 months
assessment of mental workload
using the National Aeronautics and Space Administration-Task Load Index questionnaire. Participants assess the workload of a comprehension task after reading selected texts by answering 10 questions. A rater evaluates and assigns weights to six scales based on 15 pair-wise comparisons. Each scale is represented by a line divided into intervals, with descriptors ranging from 'low' to 'high', except for 'performance', which goes from 'good' to 'poor' and is reverse scored. The overall workload score is computed by multiplying raw ratings by participant weights, summing these, and dividing by 15, resulting in a score from 0 to 100.
Measured: at baseline and after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start15 Aug 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive TrainingStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Mahmoud Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283276
- Sponsor's protocol ID
- Manar-PHD
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- 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 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Functional Core Stability Training or Cognitive Training on Balance and Postural Control in Rehabilitation of Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT07283276
- Acronym / sponsor ID
- Manar-PHD
- Conditions
- Cognitive Training, Functional Core Stability Training, Balance; Distorted, Postural Control, Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 15 Dec 2025 (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.
The purpose of the study is to investigate dynamic core stability training versus cognitive training on balance, functional performance, postural control, ankle instability scores, ankle dorsiflexion range of motion, and mental workload in chronic ankle instability
Detailed description
Lateral ankle sprains (LAS) are prevalent in sports, with 40% leading to chronic ankle instability (CAI), impacting muscle coordination and balance, primarily controlled by the central nervous system (CNS). Core muscles play a vital role in stabilization and postural control, particularly for individuals with chronic ankle instability, because they significantly contribute to the risk of injury. Even with intact strength and balance, individuals with chronic ankle instability may re-injure when attention shifts, highlighting the need for dual-task training to improve postural control. Core stability training, which includes cognitive elements, has been shown to enhance muscle function and reduce instability. Training programs incorporating dual-task exercises have proven superior for improving joint position sense and postural control while addressing associated mental health issues in chronic ankle instability patients. Therefore, this study aims to analyze the effects of combining dynamic core stability exercises with cognitive training on dual-task conditions, marking a novel approach in chronic ankle instability rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| core stability | Experimental | Other: strengthening exercises, Other: Balance training, Other: Functional core training, Other: Spinal motor control (stabilization) exercisesthey will receive traditional program plus functional core stability exercise |
| cognitive training | Experimental | Other: strengthening exercises, Other: Balance training, Other: Cognitive trainingthey will receive traditional program plus cognitive training |
| Core stability and cognitive training | Active comparator | Other: strengthening exercises, Other: Balance training, Other: Functional core training, Other: Spinal motor control (stabilization) exercises, Other: Cognitive trainingthey will receive traditional program plus functional core training plus cognitive training |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Inclusion criteria will be based on the standard criteria outlined by the International Ankle Consortium
- History of chronic lateral ankle sprain and/or recurrent sprain and/or "feelings of instability or giving way" for 6 months or more before the study, with at least 2 episodes.
- Patients are between 18 and 30 years old. 3- Body mass index less than 30
- 4. The patient has a history of at least one significant ankle sprain with associated inflammatory symptoms and at least one day of interrupted physical activity.
- 5. Patients who have unilateral chronic ankle instability. 6. Self-reported ankle instability should be confirmed using a validated ankle instability questionnaire (greater than 24).
Key exclusion criteria (2 listed)
- Those with a history of spine, pelvis, and lower extremity injury, fracture, or surgery 2- Those with low back pain that require medical or surgical intervention. 3- Having a history of an acute lower extremity injury or lower extremity surgery or fracture in the 3 months before the Study 4. Participation in formal ankle rehabilitation in the 3 months before the study.
- 5. 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 |
|---|---|---|
| strengthening exercisesStretch the gastrocnemius and soleus muscles for 30 seconds with 3 repetitions. Strengthen all ankle muscles using TheraBand resistance for various movements (dorsiflexion, plantar flexion, inversion, and eversion) and combined movements for 3 sets of 10 repetitions, three sessions weekly for two months. The training program includes progression from seated to standing for stretching and single-limb for bipedal calf raises. | Other | Core stability and cognitive training, cognitive training, core stability |
| Balance trainingChallenging disc training, utilized in balance studies, begins with participants standing with slightly bent knees. The dynamic balance training comprises 9 protocols focused on tracking a moving red circular target zone using a green point cursor that represents the center of pressure. Participants shift their body weight in various directions with visual feedback on a computer screen. Over 8 weeks, participants complete 16 sessions, each lasting 20 seconds with 7 seconds of rest in between. The time spent correctly tracking the target is measured and analyzed across all protocols. | Other | Core stability and cognitive training, cognitive training, core stability |
| Functional core trainingParticipants will receive functional core motor control (stabilization) exercise and the traditional program (consisting of stretching protocol, strengthening of all ankle muscles, and balance activities) 3 sessions per week for 2 months. | Other | Core stability and cognitive training, core stability |
| Spinal motor control (stabilization) exercisesThe training program consists of three phases: 1. Cognitive Phase (Weeks 1-2): Focuses on isolating the transversus abdominis and multifidus muscles using a biofeedback pressure device. Exercises involve isometric contractions with 10-second holds, repeated four times daily. 2. Associative Phase (Weeks 3-4): Introduces less stable exercises (e.g., quadruped and standing positions) aimed at enhancing spine neutrality. 3. Automatic Phase (Weeks 5-8): Involves dynamic movements that integrate spine control with extremity movements. Key exercises include lunges with a medicine ball, squats, and various plank variations, emphasizing co-contraction of core muscles for stability during movements. | Other | Core stability and cognitive training, core stability |
| Cognitive trainingBalance training is combined with a cognitive task involving a backward digit span test, where participants must recall and repeat sequences of numbers in reverse order, testing working memory. This test includes three difficulty levels (3-, 4-, and 5-digit sequences) performed over 35 seconds. Participants will either recall digits while maintaining static stability or after squatting upon hearing a number, with a focus on accuracy within 5 seconds. Performance is measured by the percentage of correctly recalled digits, and error scoring will be documented via video recording for each posture task. | Other | Core stability and cognitive training, cognitive training |
Primary outcome
assessment of change of pain
Time frame: at baseline and after 2 months
Ankle pain will be evaluated using the Arabic version of the Cumberland Ankle Instability Tool, which consists of questions that the patient must answer to reflect their condition. The scoring ranges from 0 to 30, with 0 indicating severe instability and 30 indicating normal stability. A score below 24 suggests Chronic Ankle Instability as defined by the International Ankle Consortium
assessment of ankle instability
Time frame: at baseline and after 2 months
Ankle instability will be evaluated using the Arabic version of the Cumberland Ankle Instability Tool, which consists of questions that the patient must answer to reflect their condition. The scoring ranges from 0 to 30, with 0 indicating severe instability and 30 indicating normal stability. A score below 24 suggests Chronic Ankle Instability as defined by the International Ankle Consortium
6 secondary outcomes
assessment of foot function
Time frame: at baseline and after 2 months
assessment of functional performance
Time frame: at baseline and after 2 months
assessment of postural control
Time frame: at baseline and after 2 months
assessment of balance
Time frame: at baseline and after 2 months
assessment of Dorsiflexion range of motion
Time frame: at baseline and after 2 months
assessment of mental workload
Time frame: at baseline and after 2 months
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 15 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strengthening exercises, Balance training and Functional core training in people with Cognitive Training and Functional Core Stability Training, 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 5 inclusion and 2 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 15 Dec 2025. 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 Manar Mahmoud Mohamed, Assistant lecturer (+20 100 758 7316, manarmahmoud690@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of change of pain (time frame: at baseline and after 2 months). The study lists 2 primary outcomes in all. 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 15 Dec 2025.