NCT05511532

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

3 active sites

Status
unknown

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 Start

First participant enrolled

January 16, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

October 18, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

July 28, 2022

Last Update Submit

October 17, 2022

Conditions

Hallux Limitus

Keywords

school-agehallux limitusplantar pressures

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Foot orthoses

EXPERIMENTAL

Hallux limitus

Other: Orthopaedic treatment

Interventions

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.

Foot orthoses

Eligibility Criteria

Age6 Years - 12 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitari Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Centre de Podologia CM

Molins de Rei, Barcelona, 08750, Spain

RECRUITING

Escola Col·legi Pare Manyanet Molins de Rei-Sant Miquel

Molins de Rei, Barcelona, 08750, Spain

COMPLETED

MeSH Terms

Conditions

Hallux Limitus

Condition Hierarchy (Ancestors)

Foot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesJoint DiseasesFoot InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Claudia Cuevas-Martinez

CONTACT

616128112claudia.cuevas@udc.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 23, 2022

Study Start

January 16, 2022

Primary Completion

December 23, 2022

Study Completion

January 18, 2023

Last Updated

October 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)