This randomized controlled trial aims to evaluate the effect of an elastic lower extremity orthosis on gait and balance in children with spastic cerebral palsy who present with an in-toeing gait pattern. The study compares conventional neurodevelopmental therapy alone to therapy combined with the orthosis.

Cerebral palsy (CP) is a group of permanent disorders affecting movement and posture and is one of the most common causes of motor disability in children. One of the most frequent rotational gait abnormalities in children with spastic CP is in-toeing, which may result from increased femoral anteversion, internal tibial torsion, or foot deformities such as metatarsus varus or metatarsus adductus.

Elastic orthoses wrapped around the femoral region can generate active rotational forces and help modify the foot progression angle during gait. In early childhood, elastic external rotation straps starting from the foot can also be used for tibial rotation problems.

This randomized controlled trial will compare the effects of conventional neurodevelopmental therapy alone with therapy combined with the use of an elastic lower extremity orthosis.

Primary outcome measure: Gait parameters

Secondary outcome measure: Balance parameters

The study hypothesizes that the group receiving the orthosis in addition to conventional therapy will demonstrate superior outcomes in terms of gait and balance compared to the control group.

Inclusion Criteria:

• Voluntary participation
• Diagnosis of spastic cerebral palsy
• Gross Motor Function Classification System (GMFCS) level 1, 2, or 3
• Age between 18 and 84 months
• Presence of in-toeing gait pattern

Exclusion Criteria:

• GMFCS level 4 or 5
• Botulinum toxin injection or surgical intervention targeting the lower extremities or pelvis within the last 6 months

De-identified individual participant data (IPD) will be made available upon reasonable request from qualified researchers with ethics approval, starting 6 months after study completion. Data sharing will be conducted under a data sharing agreement to ensure participant confidentiality.

Individual participant data and supporting documents will be available starting 6 months after study completion and will remain available for at least 5 years.

Qualified researchers with appropriate ethics committee approval may request access to the de-identified IPD and supporting documents. Data will be shared following a data sharing agreement that ensures confidentiality and appropriate use. Access requests can be made by contacting the corresponding