Foot Orthoses & Hallux Limitus in School-age Children

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.

Study Overview

• Status: Recruiting
• Conditions: Hallux Limitus
• Intervention / Treatment: Other: Orthopaedic treatment

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 Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudia Cuevas-Martinez; Phone Number: +34 616128112; Email: claudia.cuevas@udc.es

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital Universitari Universitat de Barcelona
    • Molins de Rei, Barcelona, Spain, 08750
      • Recruiting
      • Centre de Podologia CM
    • Molins de Rei, Barcelona, Spain, 08750
      • Completed
      • Escola Col·legi Pare Manyanet Molins de Rei-Sant Miquel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Foot orthoses; Hallux limitus

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidade da Coruña

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2022
• Primary Completion (ANTICIPATED): December 23, 2022
• Study Completion (ANTICIPATED): January 18, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (ACTUAL): August 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: school-age; hallux limitus; plantar pressures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Foot Injuries; Hallux Rigidus; Hallux Limitus
• Other Study ID Numbers: IRB00003099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No