Foot Orthoses & Hallux Limitus in School-age Children

Hallux Limitus Clinical Trial

Official title:

Analyze the Effectiveness of Plantar Supports in School-age Children With and Without Hallux Limitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05511532
• Other study ID #: IRB00003099
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2022
• Est. completion date: January 18, 2023

Study information

• Verified date: April 2022
• Source: Universidade da Coruña
• Contact: Claudia Cuevas-Martinez
• Phone: 616128112
• Email: claudia.cuevas[@]udc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: January 18, 2023
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hallux Limitus
• Hallux Rigidus

Intervention

Other:
• Orthopaedic treatment
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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Universitat de Barcelona	L'Hospitalet De Llobregat	Barcelona
Spain	Centre de Podologia CM	Molins de Rei	Barcelona
Spain	Escola Col·legi Pare Manyanet Molins de Rei-Sant Miquel	Molins de Rei	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universidade da Coruña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year