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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05511532
Other study ID # IRB00003099
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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