Hallux LimitusNCT07692113
Kinetic Control Versus Dynamic Taping on First Metatarsophalangeal Joint in Athletes With Functional Hallux Limitus
A study testing the standard treatment and Dynamic taping in people with Hallux Limitus, run by Cairo University at 1 site in Egypt.
Trial summary
This study is conducted to investigate and compare the effect of adding either kinetic control retraining or dynamic taping to the standard treatment program on first metatarsophalangeal joint dorsiflexion active range of motion, first metatarsophalangeal joint dorsiflexion strength, forefoot strike pattern running… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Hallux Limitus
- What is being tested?
- the standard treatment and Dynamic taping
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2026to 30 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ninety male and female indoor sports' athletes at intermediate to professional level of indoor sports.
- Athletes aged from 18 to 35 years.
- Body Mass Index ranged from 22.5- 28 kg/cm2.
- Athletes with a habitual Fore Foot Strike Pattern by determining foot strike angle using Insole Pressure Sensors.
- Athletes with less than 37° of the first metatarsophalangeal joint dorsiflexion active range of motion using a Digital Goniometer (Positive Jack test).
- Athletes with less than 50° of the first metatarsophalangeal joint dorsiflexion active range of motion using a Digital Goniometer. (Positive flexor hallucis longus stretch text).
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- Athletes with at least a 1.8-kg (4-lb) difference in first metatarsophalangeal joint dorsiflexion strength as compared to the opposite side using hand-held dynamometer.
- Athletes with pinch calluses, hyperkeratotic skin lesions identified by palpation on the medial surface of the affected first metatarsophalangeal joint (not the metatarsal head).
- Athlete's shoes must be with a minimal or no heel to toe drop design to facilitate Fore Foot Strike Pattern as Foot Strike Patterns may be facilitated partly by the shoe wear type.
- If any athlete changes the running shoes, it must be a safe transition for a few weeks to few months, to avoid injuries (stress fractures) or performance alteration.
Who cannot join
- Athletes with other habitual foot strike patterns rather than a forefoot strike pattern.
- Any limitation to the first metatarsophalangeal joint dorsiflexion active range of motion while resting plantar flexion position of the ankle.
- Athletes shoes that are cushioned with a high heel-to-toe drop which encourages Rearfoot Strike Pattern as foot strike patterns may be facilitated partly by the type of shoe wear.
- History of musculoskeletal system disorders (spine deformities, disc pathologies, orthopedic contractures, or osseous deformities such as: Sheperds fracture, Large steidas process, Ostrigonum Cysts and dorsal talar exostosis.
- History of surgeries in the last six months.
- History of neurological disorders.
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- Any preexisting injury that may become exacerbated or made worse with participation.
- History of contact dermatitis or cutaneous adverse reaction to Dynamic Tape.
- Radiological signs as first metatarsophalangeal joint head alterations, dorsal or lateral spurs, and bunion formation, as mostly radiographs of Functional Hallux Limitus are normal and these signs are more relevant to hallux rigidus which will not be evaluated in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fatemah Mahmoud Alboraei, master degree contact
Egypt1 site, 1 recruiting
- Recruiting
Fatemah M. Alboraei
Cairo, Zahraa Almaady
Fatemah Mahmoud Alboraei, Master Degree, 00201550801318, fatemah.alboraei@gmail.com
About this study
Official title: Kinetic Control Versus Dynamic Taping on First Metatarsophalangeal Joint Performance and Injury Prevention in Athletes With Functional Hallux Limitus: A Randomized Controlled Trial
This study is conducted to investigate and compare the effect of adding either kinetic control retraining or dynamic taping to the standard treatment program on first metatarsophalangeal joint dorsiflexion active range of motion, first metatarsophalangeal joint dorsiflexion strength, forefoot strike pattern running, vertical jump performance, and lower limb injury prevention in intermediate-professional level indoor sports athletes with functional hallux limitus.
Read the detailed description
this study will be conducted, using valid and reliable methods and instrumentations, to evaluate and compare the effect of adding either kinetic control retraining or dynamic taping to the standard treatment program on first metatarsophalangeal joint dorsiflexion active range of motion, first metatarsophalangeal joint dorsiflexion strength, forefoot strike pattern running, vertical jump performance and lower limb injury prevention in indoor sports athletes with functional hallux limitus. This may add a new hope to decrease the rate of injuries occurrence or recurrence which will diminish financial expenses and lengthen athletes' competitiveness time in courts.
- Conditions
- Hallux Limitus
- Being tested
- the standard treatment, Dynamic taping, kinetic control
- Medical subject headings
- Hallux Limitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the standard treatmentOther
The text details therapeutic techniques for managing first metatarsophalangeal joint (1stMTPJ) issues, including: 1) First MTPJ Manipulation with Grade IV mobilization and thrusts; 2) Subtalar Manipulation to improve mobility; 3) 1stMTPJ Mobilization through Grade III dorsal glides; 4) Sesamoid Mobilization involving rhythmic oscillations; 5) Strengthening Exercises conducted three times daily to enhance stability; 6) Flexibility Exercises for related muscle groups; and 7) Sham Taping to simulate dynamic taping effects.
Dynamic tapingOther
Athletes will receive a briefing on the taping procedure before it starts, with the option for private administration. The functional correction technique is to be applied to limit first metatarsophalangeal joint plantar flexion. This involves measuring and applying an I-shaped strip of tape from the plantar surface over the toenail to the first metatarsophalangeal joint, ensuring no tension at the joint's base. The athlete's toe should be positioned in maximum plantar flexion while severe tension (150-200%) is applied, followed by laying down a J strip on the dorsum of the joint. The remaining tape should be placed with no tension, approximately one inch below the first metatarsophalangeal joint.
kinetic controlOther
kinetic control retraining emphasizes achieving ideal lower limb (LL) sagittal alignment to activate the kinetic chain from hip to foot. Key exercises include maintaining correct femur alignment, controlling knee movement, and focusing on eccentric control of various muscle groups. Specific routines target hip (glutes), knee (popliteus), and ankle/foot levels (tibialis posterior, anterior, soleus, peroneus brevis) to enhance stability and extensibility. Mobilization strategies address extensibility of gastrocnemius, peroneus longus, and toe flexors, ensuring functional alignment and proper loading techniques during exercises.
| Study group | Role | What they receive |
|---|---|---|
| standard treatment program | Active comparator | Thirty male \& female athletes will receive the standard treatment program of Functional Hallux Limitus. Receives: Other: the standard treatment |
| standard treatment program and kinetic control | Experimental | Thirty male \& female athletes will receive kinetic control retraining added to the standard treatment program of Functional Hallux Limitus. Receives: Other: the standard treatment; Other: kinetic control |
| standard treatment program and dynamic taping | Experimental | Thirty male \& female athletes will receive dynamic taping retraining added to the standard treatment program of Functional Hallux Limitus. Receives: Other: the standard treatment; Other: Dynamic taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of active range of motion of the First metatarsophalangeal joint dorsiflexion
A digital goniometer will be utilized to measure the first metatarsophalangeal joint dorsiflexion same positions and will be marked in 1° increments. For the first metatarsophalangeal joint dorsiflexion measurements, a pen will be used to draw lines bisecting the first metatarsophalangeal joint and hallux and to mark the estimated metatarsophalangeal joint center.
Measured: (pre-intervention) and after 4 weeks (post-intervention)
Assessment of muscle strength of the First metatarsophalangeal joint dorsiflexion
Toe dynamometry is an objective tool used to measure toe flexor strength. The 'make' technique was used in all studies whereby the dynamometer is held stationary by a physical therapist or an external attachment and the athlete maximally push down onto the dynamometer with his First metatarsophalangeal joint
Measured: (pre-intervention) and after 4 weeks (post-intervention)
Forefoot running (step length, speed and propulsion rate)
therapist will place the Digitsole Pro system of intelligent pressure sensors and Digitsole pods in athletes' shoes to export data while running for 5 minutes after a sufficient warm-up for eight minutes of jogging. A compiled running performance data analysis of step length, speed, and propulsion rate will show in the form of dashboards through the Digitsole Pro® applications on an external tablet or mobile device.
Measured: (pre-intervention) and after 4 weeks (post-intervention)
Vertical jumping performance (flight time, vertical jump height, and takeoff velocity)
PT will Place the Digitsole Pro system of ntelligent pressure sensors and Digitsole pods in athletes' shoes to export data while dynamic vertical jumb for 5 minutes after a sufficient warm up for eight minutes of jogging. A compiled vertical jumb performance data analysis of flight time, vertical jump height and tack-off velocity will show in the form of dashboards through the Digitsole Pro® applications on an external tablet or mobile device.
Measured: (pre-intervention) and after 4 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start25 Mar 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux LimitusStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatemah M. Alboraei, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692113
- Sponsor's protocol ID
- P.T.REC/012/006173
- Status last verified
- Jul 2026
- First submitted
- 6 Mar 2026
- Last updated
- 9 Jul 2026
- 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetic Control Versus Dynamic Taping on First Metatarsophalangeal Joint Performance and Injury Prevention in Athletes With Functional Hallux Limitus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07692113
- Acronym / sponsor ID
- P.T.REC/012/006173
- Conditions
- Hallux Limitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 9 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 is conducted to investigate and compare the effect of adding either kinetic control retraining or dynamic taping to the standard treatment program on first metatarsophalangeal joint dorsiflexion active range of motion, first metatarsophalangeal joint dorsiflexion strength, forefoot strike pattern running, vertical jump performance, and lower limb injury prevention in intermediate-professional level indoor sports athletes with functional hallux limitus.
Detailed description
this study will be conducted, using valid and reliable methods and instrumentations, to evaluate and compare the effect of adding either kinetic control retraining or dynamic taping to the standard treatment program on first metatarsophalangeal joint dorsiflexion active range of motion, first metatarsophalangeal joint dorsiflexion strength, forefoot strike pattern running, vertical jump performance and lower limb injury prevention in indoor sports athletes with functional hallux limitus. This may add a new hope to decrease the rate of injuries occurrence or recurrence which will diminish financial expenses and lengthen athletes' competitiveness time in courts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard treatment program | Active comparator | Other: the standard treatmentThirty male \& female athletes will receive the standard treatment program of Functional Hallux Limitus. |
| standard treatment program and kinetic control | Experimental | Other: the standard treatment, Other: kinetic controlThirty male \& female athletes will receive kinetic control retraining added to the standard treatment program of Functional Hallux Limitus. |
| standard treatment program and dynamic taping | Experimental | Other: the standard treatment, Other: Dynamic tapingThirty male \& female athletes will receive dynamic taping retraining added to the standard treatment program of Functional Hallux Limitus. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Ninety male and female indoor sports' athletes at intermediate to professional level of indoor sports.
- Athletes aged from 18 to 35 years.
- Body Mass Index ranged from 22.5- 28 kg/cm2.
- Athletes with a habitual Fore Foot Strike Pattern by determining foot strike angle using Insole Pressure Sensors.
- Athletes with less than 37° of the first metatarsophalangeal joint dorsiflexion active range of motion using a Digital Goniometer (Positive Jack test).
Key exclusion criteria (9 listed)
- Athletes with other habitual foot strike patterns rather than a forefoot strike pattern.
- Any limitation to the first metatarsophalangeal joint dorsiflexion active range of motion while resting plantar flexion position of the ankle.
- Athletes shoes that are cushioned with a high heel-to-toe drop which encourages Rearfoot Strike Pattern as foot strike patterns may be facilitated partly by the type of shoe wear.
- History of musculoskeletal system disorders (spine deformities, disc pathologies, orthopedic contractures, or osseous deformities such as: Sheperds fracture, Large steidas process, Ostrigonum Cysts and dorsal talar exostosis.
- History of surgeries in the last six months.
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 |
|---|---|---|
| the standard treatmentThe text details therapeutic techniques for managing first metatarsophalangeal joint (1stMTPJ) issues, including: 1) First MTPJ Manipulation with Grade IV mobilization and thrusts; 2) Subtalar Manipulation to improve mobility; 3) 1stMTPJ Mobilization through Grade III dorsal glides; 4) Sesamoid Mobilization involving rhythmic oscillations; 5) Strengthening Exercises conducted three times daily to enhance stability; 6) Flexibility Exercises for related muscle groups; and 7) Sham Taping to simulate dynamic taping effects. | Other | standard treatment program, standard treatment program and dynamic taping, standard treatment program and kinetic control |
| Dynamic tapingAthletes will receive a briefing on the taping procedure before it starts, with the option for private administration. The functional correction technique is to be applied to limit first metatarsophalangeal joint plantar flexion. This involves measuring and applying an I-shaped strip of tape from the plantar surface over the toenail to the first metatarsophalangeal joint, ensuring no tension at the joint's base. The athlete's toe should be positioned in maximum plantar flexion while severe tension (150-200%) is applied, followed by laying down a J strip on the dorsum of the joint. The remaining tape should be placed with no tension, approximately one inch below the first metatarsophalangeal joint. | Other | standard treatment program and dynamic taping |
| kinetic controlkinetic control retraining emphasizes achieving ideal lower limb (LL) sagittal alignment to activate the kinetic chain from hip to foot. Key exercises include maintaining correct femur alignment, controlling knee movement, and focusing on eccentric control of various muscle groups. Specific routines target hip (glutes), knee (popliteus), and ankle/foot levels (tibialis posterior, anterior, soleus, peroneus brevis) to enhance stability and extensibility. Mobilization strategies address extensibility of gastrocnemius, peroneus longus, and toe flexors, ensuring functional alignment and proper loading techniques during exercises. | Other | standard treatment program and kinetic control |
Primary outcome
Assessment of active range of motion of the First metatarsophalangeal joint dorsiflexion
Time frame: (pre-intervention) and after 4 weeks (post-intervention)
A digital goniometer will be utilized to measure the first metatarsophalangeal joint dorsiflexion same positions and will be marked in 1° increments. For the first metatarsophalangeal joint dorsiflexion measurements, a pen will be used to draw lines bisecting the first metatarsophalangeal joint and hallux and to mark the estimated metatarsophalangeal joint center.
Assessment of muscle strength of the First metatarsophalangeal joint dorsiflexion
Time frame: (pre-intervention) and after 4 weeks (post-intervention)
Toe dynamometry is an objective tool used to measure toe flexor strength. The 'make' technique was used in all studies whereby the dynamometer is held stationary by a physical therapist or an external attachment and the athlete maximally push down onto the dynamometer with his First metatarsophalangeal joint
Forefoot running (step length, speed and propulsion rate)
Time frame: (pre-intervention) and after 4 weeks (post-intervention)
therapist will place the Digitsole Pro system of intelligent pressure sensors and Digitsole pods in athletes' shoes to export data while running for 5 minutes after a sufficient warm-up for eight minutes of jogging. A compiled running performance data analysis of step length, speed, and propulsion rate will show in the form of dashboards through the Digitsole Pro® applications on an external tablet or mobile device.
Vertical jumping performance (flight time, vertical jump height, and takeoff velocity)
Time frame: (pre-intervention) and after 4 weeks (post-intervention)
PT will Place the Digitsole Pro system of ntelligent pressure sensors and Digitsole pods in athletes' shoes to export data while dynamic vertical jumb for 5 minutes after a sufficient warm up for eight minutes of jogging. A compiled vertical jumb performance data analysis of flight time, vertical jump height and tack-off velocity will show in the form of dashboards through the Digitsole Pro® applications on an external tablet or mobile device.
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 9 Jul 2026.
- 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.
Fatemah Mahmoud Alboraei, master degree contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the standard treatment and Dynamic taping in people with Hallux Limitus, 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 10 inclusion and 9 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 9 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 Fatemah Mahmoud Alboraei, master degree (00201550801318 ext. 00201010330474, fatemah.alboraei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of active range of motion of the First metatarsophalangeal joint dorsiflexion (time frame: (pre-intervention) and after 4 weeks (post-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 9 Jul 2026.