NCT07692113

Brief 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, vertical jump performance, and lower limb injury prevention in intermediate-professional level indoor sports athletes with functional hallux limitus.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

March 6, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

March 6, 2026

Last Update Submit

July 2, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    (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

    (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.

    (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.

    (pre-intervention) and after 4 weeks (post-intervention)

Study Arms (3)

standard treatment program

ACTIVE COMPARATOR

Thirty male \& female athletes will receive the standard treatment program of Functional Hallux Limitus.

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.

Other: the standard treatmentOther: 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.

Other: the standard treatmentOther: Dynamic taping

Interventions

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.

standard treatment programstandard treatment program and dynamic tapingstandard treatment program and kinetic control

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.

standard treatment program and dynamic taping

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.

standard treatment program and kinetic control

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatemah M. Alboraei

Cairo, Zahraa Almaady, Egypt

RECRUITING

MeSH Terms

Conditions

Hallux Limitus

Condition Hierarchy (Ancestors)

Foot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesJoint DiseasesFoot InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Fatemah Mahmoud Alboraei, master degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 6, 2026

First Posted

July 9, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations