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The effectiveness of using Limb rotation band for treatment of Femoral anteversion in children with in-toeing: a randomized clinical trial

Study and development of Orthosis for treatment of Femoral anteversion in children with In-Toeing: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4w9jscv
Enrollment
Unknown
Registered
2025-04-09
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metatarsus Varus

Interventions

This is an open-label randomized clinical trial between parallel groups. Randomization by group will have a 1:1 allocation sequence, generated by computer and used to randomly assign participants to t
E02.779

Sponsors

Universidade Federal do Amazonas
Lead Sponsor
Universidade Federal do Amazonas
Collaborator

Eligibility

Age
4 Years to 10 Years

Inclusion criteria

Inclusion criteria: Children of both sexes; Age between 4 and 10 years; Present in-toeing pattern due to femoral anteversion; absence of neuromotor or behavioral alteration; gait angle less than -3° and internal rotation of the hip greater than 70°; do not present in-toeing due to internal torsion of the tibia and metatarsus adductus or excessive deformity indicating surgery (over 80° of internal rotation); do not present a history of surgery; fractures in limbs and deformities that affect gait (for example, clubfoot, dislocation of the hip joint)

Exclusion criteria

Exclusion criteria: Low adherence to daily use of the orthosis (less than 4 hours reported); presence of allergies or irritability when using the orthosis; orthopedic surgeries on lower limbs involving the hip; possible fractures in the lower limbs; interruption in the use of the orthosis for more than 15 total days or 7 calendar days; withdrawals

Design outcomes

Primary

MeasureTime frame
To assess the angle of internal rotation of the hip, which will be measured using a motion analysis system using precision infrared cameras (Vicon Vero System). Therefore, reflective markers should be positioned on the acromion, anterior superior iliac spine (ASIS), greater trochanter, head of the fibula, lateral malleolus and head of the fifth metatarsal. The data will be recorded on electronic media and later analyzed using the system's standard software (Vicon Nexus 2), obtaining: 1) Average angle and range of motion of the hip, knee and ankle and 2) Temporal sequence of contact between the forefoot and the heel, calculated based on the time course of the position of the markers on the malleolus and fifth metatarsal

Secondary

MeasureTime frame
For each participant, the mean values ??of the kinematic gait parameters will also be obtained via the same system: speed (m/s), cadence (steps/min), step length (m), gait cycle duration (s) and pelvic tilts. These data will allow comparison between children in the experimental and control groups, as well as in the experimental group before and after the introduction of the orthosis

Countries

Brazil

Contacts

Public ContactLeonardo Brandão

Universidade Federal do Amazonas

leonardocarvalhobr@outlook.com+55 (92) 982570060

Outcome results

None listed

Source: REBEC (via WHO ICTRP)