Chronic Ankle Instability, CAINCT07078916
MOTOR TRAINING VERSUS MOTOR COGNITIVE TRAINING IN ATHLETES WITH CHRONIC ANKLE INSTABILITY
A study testing Motor-Cognitive Training Group (OLBA + BlazePod™) and Motor Training Group (OLBA Only) in people with Chronic Ankle Instability, CAI, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of one-leg balance activity (OLBA) combined with visual feedback using BlazePod™ as a dual motor-cognitive rehabilitation task in basketball players with Chronic Ankle Instability (CAI). The intervention will be compared to OLBA alone as a motor task. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Chronic Ankle Instability, CAI
- What is being tested?
- Motor-Cognitive Training Group (OLBA + BlazePod™) and Motor Training Group (OLBA Only)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Apr 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
- Young adult basketball athletes aged between (18 - 30) years.
- A history of unilateral one or more significant ankle inversion injury occurred at least 1 year before participation in the study.
- Interruption of physical activity or cessation from training for at least 24 hours following injury.
- Report episodes of giving way and sense of instability of the affected ankle.
- Two episodes of giving way or/ recurrent inversion injury should be reported by the patient before study enrollment at least two times in the last 6 months.
- Cumberland Ankle Instability Tool (CAIT) patient scores < 24.
Who cannot join
- A history of previous surgery or fracture to musculoskeletal structure (bone, joint, etc.) in the limb of the affected ankle.
- Acute lower limb sprain in the last 3 months before enrollment in the study resulting in interruption of physical activity for 1 day.
- Any disorder or disease that could affect the balance as vestibular disorders, eye injury, and so on.
- Any athlete who participates in any formal or informal rehabilitation.
- Participants who will not commit to two successive sessions will also be considered for exclusion.
- If they received NSAID 2 weeks before enrollment in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
moaid mohamed elzarka, Bachelor of Physiotherapy contact
afaf mohamed tahoon, Ph.D. in Physical Therapy contact
Egypt1 site
Aman physical therapy center
Alexandria, 21532
Aman Physiotherapy Center, +201008131372, aman.physicaltherapy.center@gmail.com
About this study
This study aims to evaluate the effect of one-leg balance activity (OLBA) combined with visual feedback using BlazePod™ as a dual motor-cognitive rehabilitation task in basketball players with Chronic Ankle Instability (CAI). The intervention will be compared to OLBA alone as a motor task. Outcomes measured include dynamic balance, sense of instability, response time, athletic performance, and self-reported physical function. This study will help improve rehabilitation strategies for athletes suffering from ankle instability.
Read the detailed description
- Chronic Ankle Instability (CAI) is a common condition among athletes, particularly basketball players, characterized by recurrent ankle sprains, impaired balance, and reduced functional performance. Effective rehabilitation strategies are crucial for restoring joint stability and preventing further injury.
- This study aims to compare the effects of motor-cognitive training versus motor training alone in basketball players with CAI. Participants will be randomly assigned into two groups: the first group will perform one-leg balance activity (OLBA) combined with visual feedback using BlazePod™ technology, while the second group will perform OLBA alone without visual feedback.
- The sample will be recruited from basketball teams through referral of athletes previously diagnosed with CAI, who continue to experience a feeling of ankle instability and recurrent "giving way" episodes at least one year after the initial lateral ankle sprain (LAS).
- The intervention will be conducted over 4 weeks, with 3 sessions per week. Each session will include 3 trials of the assigned OLBA task, with each trial lasting 30 seconds and a rest period of 1 minute between trials.
- The primary research question addressed by this study is: among basketball players with CAI, is there a significant difference between OLBA with visual feedback (BlazePod™) and OLBA alone in terms of dynamic balance, perceived instability, response time, athletic performance, and self-reported physical function?
- This study will contribute to the growing body of literature on dynamic balance training by comparing traditional motor tasks with dual-task training approaches that integrate cognitive-motor challenges using BlazePod™. BlazePod™ technology has demonstrated moderate to excellent reliability, particularly when used to provide feedback and monitor response during OLBA.
- Findings from this research may help healthcare professionals better understand the potential benefits of incorporating visual feedback and dual-task training into rehabilitation protocols for athletes with CAI. The results may also support the use of BlazePod™ as a tool for monitoring performance changes and facilitating motor learning in sports rehabilitation contexts.
- Conditions
- Chronic Ankle Instability, CAI
- Being tested
- Motor-Cognitive Training Group (OLBA + BlazePod™), Motor Training Group (OLBA Only)
- Keywords
- Ankle Injuries [MeSH], Ankle Sprain, Chronic Ankle Instability, Basketball Players, Balance Rehabilitation [MeSH], Motor Skills [MeSH], Cognitive Training [MeSH], Visual Feedback, BlazePod, Dual-task Training, Dynamic Balance, Motor-Cognitive Training, Reaction Time
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor-Cognitive Training Group (OLBA + BlazePod™)Behavioural
Arm 1 participant will receive the One-leg-balance activity using visual feedback BlazePod technology as a dual motor-cognitive task training.
Motor Training Group (OLBA Only)Behavioural
Arm 2 participant will receive a the One-leg-balance activity as a single motor task.
| Study group | Role | What they receive |
|---|---|---|
| Motor-Cognitive Training Group (OLBA + BlazePod™) | Experimental | Participants in this group will perform one-leg balance activities combined with visual feedback using BlazePod™ Receives: Behavioral: Motor-Cognitive Training Group (OLBA + BlazePod™) |
| Motor Training Group (OLBA Only) | Active comparator | Participants in this group will perform one-leg balance activities without any visual feedback. Receives: Behavioral: Motor Training Group (OLBA Only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic balance
Dynamic balance will be assessed using the Y-Balance Test, a reliable and valid tool for measuring postural control in three directions: anterior, posteromedial, and posterolateral.
The participant will be asked to stand on the injured leg, then using another leg to reach the maximal point along the line in the three different directions, the directions named concerning the contact leg. The length of the line is normalized by the length of the patient's limb which is measured from ASIS to the medial malleolus.
The goal of this test is to reach maximum excursion in every direction without shifting weight to or coming to rest on this foot of the reaching limb and then return the reaching limb to the beginning position in the center.
Three trials in each direction to be familiarized. Actual trials will be 3 trials and best score will be calculated, The test will be conducted at baseline and after 4 weeks of intervention.
Measured: At baseline and after 4 weeks of intervention
Sense of instability
Sense of ankle instability will be assessed using the Cumberland Ankle Instability Tool (CAIT), Consist of 32 points with a score less than 24 indicating CAI according to the International Ankle Consortium.
The tool will be used in the Arabic version. The participants will be asked to choose the most suitable answer, with lower scores indicating greater perceived instability.
Measured: The CAIT will be administered at baseline and after 4 weeks of intervention.
Response time.
Response time will be measured through the BlazePod™ application, BlazePod™ is a method of motor learning assessment and cognitive motor training.
BlazePod™ sensors are reactive lights that turn off or deactivate with contact, They are controlled via smartphone applications using Bluetooth low energy technology and allow for full customization of 10 colored lights which record time variables from activation until deactivation. In this scenario, pods will activate automatically and randomly with a timer and deactivate with the impact of the foot touching the top.
Lower response time means better motor learning and is calculated automatically through the BlazePod application.
Measured: Assessment will be conducted at baseline and after 4 weeks of intervention
Self-reported physical function
Self-reported physical function will be assessed using the Sport subscale of the Foot and Ankle Ability Measure (FAAM), a validated tool for evaluating functional limitations related to sports activities in individuals with foot and ankle disorders.
The Sport subscale consists of 8 items, he response to each item on the Sports subscale is scored from 4 to 0, with 4 being "no difficulty" and 0 being "unable to do", scores on each item are added together to get the item score total, the highest potential score of the questioner is 32, The item score total is divided by the highest potential score.
This value is multiplied by 100 to get a percentage, A higher score represents a higher level of physical function. with higher scores indicating better function.
FAAM sport subscale will be used in Arabic version.
Measured: The questionnaire will be administered at baseline and after 4 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle Instability, CAIStudies 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
- Model description
- Double-blind parallel design randomized control study with allocation ratio 1:1
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jilan Adel yousef, Kafrelsheikh University
- Investigators
- nasr awad abdelkader, Ph.D. in Physical Therapy, Principal investigator, Assistant Professor of Physical Therapy for Musculoskeletal Disorders and its Surgeries, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078916
- Sponsor's protocol ID
- P.T.REC/012/005726
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOTOR TRAINING VERSUS MOTOR COGNITIVE TRAINING IN ATHLETES WITH CHRONIC ANKLE INSTABILITY
- ClinicalTrials.gov ID
- NCT07078916
- Acronym / sponsor ID
- P.T.REC/012/005726
- Conditions
- Chronic Ankle Instability, CAI
- Keywords
- Ankle Injuries [MeSH], Ankle Sprain, Chronic Ankle Instability, Basketball Players, Balance Rehabilitation [MeSH], Motor Skills [MeSH], Cognitive Training [MeSH], Visual Feedback
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 22 Jul 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.
This study aims to evaluate the effect of one-leg balance activity (OLBA) combined with visual feedback using BlazePod™ as a dual motor-cognitive rehabilitation task in basketball players with Chronic Ankle Instability (CAI). The intervention will be compared to OLBA alone as a motor task. Outcomes measured include dynamic balance, sense of instability, response time, athletic performance, and self-reported physical function. This study will help improve rehabilitation strategies for athletes suffering from ankle instability.
Detailed description
- Chronic Ankle Instability (CAI) is a common condition among athletes, particularly basketball players, characterized by recurrent ankle sprains, impaired balance, and reduced functional performance. Effective rehabilitation strategies are crucial for restoring joint stability and preventing further injury.
- This study aims to compare the effects of motor-cognitive training versus motor training alone in basketball players with CAI. Participants will be randomly assigned into two groups: the first group will perform one-leg balance activity (OLBA) combined with visual feedback using BlazePod™ technology, while the second group will perform OLBA alone without visual feedback.
- The sample will be recruited from basketball teams through referral of athletes previously diagnosed with CAI, who continue to experience a feeling of ankle instability and recurrent "giving way" episodes at least one year after the initial lateral ankle sprain (LAS).
- The intervention will be conducted over 4 weeks, with 3 sessions per week. Each session will include 3 trials of the assigned OLBA task, with each trial lasting 30 seconds and a rest period of 1 minute between trials.
- The primary research question addressed by this study is: among basketball players with CAI, is there a significant difference between OLBA with visual feedback (BlazePod™) and OLBA alone in terms of dynamic balance, perceived instability, response time, athletic performance, and self-reported physical function?
- This study will contribute to the growing body of literature on dynamic balance training by comparing traditional motor tasks with dual-task training approaches that integrate cognitive-motor challenges using BlazePod™. BlazePod™ technology has demonstrated moderate to excellent reliability, particularly when used to provide feedback and monitor response during OLBA.
- Findings from this research may help healthcare professionals better understand the potential benefits of incorporating visual feedback and dual-task training into rehabilitation protocols for athletes with CAI. The results may also support the use of BlazePod™ as a tool for monitoring performance changes and facilitating motor learning in sports rehabilitation contexts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind parallel design randomized control study with allocation ratio 1:1
| Arm | Type | Receives |
|---|---|---|
| Motor-Cognitive Training Group (OLBA + BlazePod™) | Experimental | Behavioral: Motor-Cognitive Training Group (OLBA + BlazePod™)Participants in this group will perform one-leg balance activities combined with visual feedback using BlazePod™ |
| Motor Training Group (OLBA Only) | Active comparator | Behavioral: Motor Training Group (OLBA Only)Participants in this group will perform one-leg balance activities without any visual feedback. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Young adult basketball athletes aged between (18 - 30) years.
- A history of unilateral one or more significant ankle inversion injury occurred at least 1 year before participation in the study.
- Interruption of physical activity or cessation from training for at least 24 hours following injury.
- Report episodes of giving way and sense of instability of the affected ankle.
- Two episodes of giving way or/ recurrent inversion injury should be reported by the patient before study enrollment at least two times in the last 6 months.
Key exclusion criteria (6 listed)
- A history of previous surgery or fracture to musculoskeletal structure (bone, joint, etc.) in the limb of the affected ankle.
- Acute lower limb sprain in the last 3 months before enrollment in the study resulting in interruption of physical activity for 1 day.
- Any disorder or disease that could affect the balance as vestibular disorders, eye injury, and so on.
- Any athlete who participates in any formal or informal rehabilitation.
- Participants who will not commit to two successive sessions will also be considered for exclusion.
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 |
|---|---|---|
| Motor-Cognitive Training Group (OLBA + BlazePod™)Arm 1 participant will receive the One-leg-balance activity using visual feedback BlazePod technology as a dual motor-cognitive task training. | Behavioural | Motor-Cognitive Training Group (OLBA + BlazePod™) |
| Motor Training Group (OLBA Only)Arm 2 participant will receive a the One-leg-balance activity as a single motor task. | Behavioural | Motor Training Group (OLBA Only) |
Primary outcome
Dynamic balance
Time frame: At baseline and after 4 weeks of intervention
Dynamic balance will be assessed using the Y-Balance Test, a reliable and valid tool for measuring postural control in three directions: anterior, posteromedial, and posterolateral. The participant will be asked to stand on the injured leg, then using another leg to reach the maximal point along the line in the three different directions, the directions named concerning the contact leg. The length of the line is normalized by the length of the patient's limb which is measured from ASIS to the medial malleolus. The goal of this test is to reach maximum excursion in every direction without shifting weight to or coming to rest on this foot of the reaching limb and then return the reaching limb to the beginning position in the center. Three trials in each direction to be familiarized. Actual trials will be 3 trials and best score will be calculated, The test will be conducted at baseline and after 4 weeks of intervention.
Sense of instability
Time frame: The CAIT will be administered at baseline and after 4 weeks of intervention.
Sense of ankle instability will be assessed using the Cumberland Ankle Instability Tool (CAIT), Consist of 32 points with a score less than 24 indicating CAI according to the International Ankle Consortium. The tool will be used in the Arabic version. The participants will be asked to choose the most suitable answer, with lower scores indicating greater perceived instability.
Response time.
Time frame: Assessment will be conducted at baseline and after 4 weeks of intervention
Response time will be measured through the BlazePod™ application, BlazePod™ is a method of motor learning assessment and cognitive motor training. BlazePod™ sensors are reactive lights that turn off or deactivate with contact, They are controlled via smartphone applications using Bluetooth low energy technology and allow for full customization of 10 colored lights which record time variables from activation until deactivation. In this scenario, pods will activate automatically and randomly with a timer and deactivate with the impact of the foot touching the top. Lower response time means better motor learning and is calculated automatically through the BlazePod application.
Self-reported physical function
Time frame: The questionnaire will be administered at baseline and after 4 weeks of intervention.
Self-reported physical function will be assessed using the Sport subscale of the Foot and Ankle Ability Measure (FAAM), a validated tool for evaluating functional limitations related to sports activities in individuals with foot and ankle disorders. The Sport subscale consists of 8 items, he response to each item on the Sports subscale is scored from 4 to 0, with 4 being "no difficulty" and 0 being "unable to do", scores on each item are added together to get the item score total, the highest potential score of the questioner is 32, The item score total is divided by the highest potential score. This value is multiplied by 100 to get a percentage, A higher score represents a higher level of physical function. with higher scores indicating better function. FAAM sport subscale will be used in Arabic version.
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 22 Jul 2025.
- Individual participant dataSharing planned: No
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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.
moaid mohamed elzarka, Bachelor of Physiotherapy contact
afaf mohamed tahoon, Ph.D. in Physical Therapy contact
nasr awad abdelkader, Ph.D. in Physical Therapy principal investigator
Assistant Professor of Physical Therapy for Musculoskeletal Disorders and its Surgeries, Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor-Cognitive Training Group (OLBA + BlazePod™) and Motor Training Group (OLBA Only) in people with Chronic Ankle Instability, CAI, 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 6 inclusion and 6 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 22 Jul 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 moaid mohamed elzarka, Bachelor of Physiotherapy (+201000177695 ext. +201507771315, moaidelzarka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic balance (time frame: At baseline and after 4 weeks of intervention). The study lists 4 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 22 Jul 2025.