Foot Orthoses & Hallux Limitus in School-age Children
Primary Purpose
Hallux Limitus
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Orthopaedic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Limitus focused on measuring school-age, hallux limitus, plantar pressures
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitari Universitat de BarcelonaRecruiting
- Centre de Podologia CMRecruiting
- Escola Col·legi Pare Manyanet Molins de Rei-Sant Miquel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Foot orthoses
Arm Description
Hallux limitus
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05511532
Brief Title
Foot Orthoses & Hallux Limitus in School-age Children
Official Title
Analyze the Effectiveness of Plantar Supports in School-age Children With and Without Hallux Limitus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2022 (Actual)
Primary Completion Date
December 23, 2022 (Anticipated)
Study Completion Date
January 18, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade da Coruña
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Limitus
Keywords
school-age, hallux limitus, plantar pressures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Foot orthoses
Arm Type
Experimental
Arm Description
Hallux limitus
Intervention Type
Other
Intervention Name(s)
Orthopaedic treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hallux limitus
Description
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.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Cuevas-Martinez
Phone
616128112
Ext
+34
Email
claudia.cuevas@udc.es
Facility Information:
Facility Name
Hospital Universitari Universitat de Barcelona
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centre de Podologia CM
City
Molins de Rei
State/Province
Barcelona
ZIP/Postal Code
08750
Country
Spain
Individual Site Status
Recruiting
Facility Name
Escola Col·legi Pare Manyanet Molins de Rei-Sant Miquel
City
Molins de Rei
State/Province
Barcelona
ZIP/Postal Code
08750
Country
Spain
Individual Site Status
Completed
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Foot Orthoses & Hallux Limitus in School-age Children
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