Hallux LimitusNCT05511532
Foot Orthoses & Hallux Limitus in School-age Children
A study testing Orthopaedic treatment in people with Hallux Limitus, run by Universidade da Coruña at 3 sites in Spain.
Trial summary
The most important pivot of the sagittal plane is in the first metatarsophalangeal joint, which is usually restricted or blocked as a result of alterations in the rest of the planes or as the main cause of secondary compensations. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Limitus
- What is being tested?
- Orthopaedic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesSpain
- Study dates
- 16 Jan 2022to 18 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Interest in participating and completing the phases of the study and signing of the informed consent by the parents. Patients who do not meet any exclusion criteria will be included.
Who cannot join
- The exclusion criteria will be refusal to sign the informed consent, hypermobility, neurological diseases, previous traumatic history affecting one or both lower extremities, rheumatic pathologies, as well as patients with an angular value of the first metatarsophalangeal joint less than 10º and ankle flexion less than 10º with the knee in extension.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 2 recruiting
- Recruiting
Hospital Universitari Universitat de Barcelona
L'Hospitalet de Llobregat, Barcelona, 08907
- Recruiting
Centre de Podologia CM
Molins de Rei, Barcelona, 08750
- Completed
Escola Col·legi Pare Manyanet Molins de Rei-Sant Miquel
Molins de Rei, Barcelona, 08750
About this study
Official title: Analyze the Effectiveness of Plantar Supports in School-age Children With and Without Hallux Limitus
The most important pivot of the sagittal plane is in the first metatarsophalangeal joint, which is usually restricted or blocked as a result of alterations in the rest of the planes or as the main cause of secondary compensations.
Read the detailed description
In the propulsion phase, once the hallux touches the ground, it does not move again until the moment of take-off, so when there is a limitation of the plantar flexion of the hallux, the compensation of this is appreciated in other anatomical locations during gait analysis.
For the propulsion phase to be effective, the first metatarsophalangeal joint must be maximally dorsiflexed.
If any structure or movement is altered, the axis varies. In the hallux, the joint surface on which the movement is performed is reduced and therefore affected at the dorsal level, causing a limitation of the main movement of this joint; dorsiflexion in closed kinetic chain, known as functional hallux limitus.
It is for this reason that it is proposed to study the application of plantar supports to favor the movement of dorsiflexion of the first metatarsophalangeal joint and avoid an early establishment of the hallux limitus.
- Conditions
- Hallux Limitus
- Being tested
- Orthopaedic treatment
- Keywords
- school-age, hallux limitus, plantar pressures
- Medical subject headings
- Hallux Limitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopaedic treatmentOther
Female and male patients aged between 6 and 12 years are included in the study. Initially, the values of dorsiflexion of the tibio-fibular-talar joint and dorsiflexion of the first metatarsophalangeal joint will be measured to rule out hallux rigidus and ankle equinus, respectively.
Those patients who do not present hallux rigidus or equinus ankle, will be included in the study and will have their computerized foot pressures taken.
| Study group | Role | What they receive |
|---|---|---|
| Foot orthoses | Experimental | Hallux limitus Receives: Other: Orthopaedic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hallux limitus
hallux limitus is defined as a limitation of dorsiflexion of the 1st metatarsophalangeal joint of the foot.
In the functional hallux limitus test, the doctor uses one hand to hold the first ray in a dorsi-flexed position by loading the first metatarsal head and the other hand to dorsiflex the proximal phalanx of the hallux.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start16 Jan 2022
- Primary completion23 Dec 2022 (estimated)
- Study completion18 Jan 2023 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511532
- Sponsor's protocol ID
- IRB00003099
- Status last verified
- Apr 2022
- First submitted
- 28 Jul 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyze the Effectiveness of Plantar Supports in School-age Children With and Without Hallux Limitus
- ClinicalTrials.gov ID
- NCT05511532
- Acronym / sponsor ID
- IRB00003099
- Conditions
- Hallux Limitus
- Keywords
- school-age, hallux limitus, plantar pressures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Study start
- 16 Jan 2022 (actual)
- Primary completion
- 23 Dec 2022 (estimated)
- Study completion
- 18 Jan 2023 (estimated)
- First posted
- 23 Aug 2022 (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 most important pivot of the sagittal plane is in the first metatarsophalangeal joint, which is usually restricted or blocked as a result of alterations in the rest of the planes or as the main cause of secondary compensations.
Detailed description
In the propulsion phase, once the hallux touches the ground, it does not move again until the moment of take-off, so when there is a limitation of the plantar flexion of the hallux, the compensation of this is appreciated in other anatomical locations during gait analysis.
For the propulsion phase to be effective, the first metatarsophalangeal joint must be maximally dorsiflexed.
If any structure or movement is altered, the axis varies. In the hallux, the joint surface on which the movement is performed is reduced and therefore affected at the dorsal level, causing a limitation of the main movement of this joint; dorsiflexion in closed kinetic chain, known as functional hallux limitus.
It is for this reason that it is proposed to study the application of plantar supports to favor the movement of dorsiflexion of the first metatarsophalangeal joint and avoid an early establishment of the hallux limitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Foot orthoses | Experimental | Other: Orthopaedic treatmentHallux limitus |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Interest in participating and completing the phases of the study and signing of the informed consent by the parents. Patients who do not meet any exclusion criteria will be included.
Key exclusion criteria (1 listed)
- The exclusion criteria will be refusal to sign the informed consent, hypermobility, neurological diseases, previous traumatic history affecting one or both lower extremities, rheumatic pathologies, as well as patients with an angular value of the first metatarsophalangeal joint less than 10º and ankle flexion less than 10º with the knee in extension.
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 |
|---|---|---|
| Orthopaedic treatmentFemale and male patients aged between 6 and 12 years are included in the study. Initially, the values of dorsiflexion of the tibio-fibular-talar joint and dorsiflexion of the first metatarsophalangeal joint will be measured to rule out hallux rigidus and ankle equinus, respectively. Those patients who do not present hallux rigidus or equinus ankle, will be included in the study and will have their computerized foot pressures taken. | Other | Foot orthoses |
Primary outcome
Hallux limitus
Time frame: through study completion, an average of 1 year
hallux limitus is defined as a limitation of dorsiflexion of the 1st metatarsophalangeal joint of the foot. In the functional hallux limitus test, the doctor uses one hand to hold the first ray in a dorsi-flexed position by loading the first metatarsal head and the other hand to dorsiflex the proximal phalanx of the hallux.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Hallux Limitus
Active, not recruiting
The Hyalex MTP Study
Hallux Valgus, Hallux Limitus
Recruiting
Kinetic Control Versus Dynamic Taping on First Metatarsophalangeal Joint in Athletes With Functional Hallux Limitus
Hallux Limitus
Not yet recruitingObservational study
Return to Cross Country Skiing and Other Physical Activities After Arthrodesis of the First Metatarsophalangeal Joint
Hallux Rigidus, Hallux Valgus
Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
Not yet recruiting
Effect of Foot Core Control Training on Dorsiflexion Function and Gait Biomechanical Characteristics of Patients With Chronic Plantar Fasciitis
Chronic Plantar Fasciitis, Functional Hallux Limitus
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. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthopaedic treatment in people with Hallux Limitus, run by Universidade da Coruña at 3 sites in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia Cuevas-Martinez (616128112 ext. +34, claudia.cuevas@udc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hallux limitus (time frame: through study completion, an average of 1 year). 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 18 Oct 2022.