NCT07122362

Effect of Elastic Lower Extremity Orthosis on Gait and Balance in Children With Spastic Cerebral Palsy

Investigation of the Effect of Elastic Lower Extremity Orthosis on Gait and Balance Parameters in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Gazi University · Academic / Other
• Sex: All
• Age: 18 Months – 84 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Spastic Cerebral Palsy

Interventions

Type	Name	Description
DEVICE	Elastic Lower Extremity Orthosis	Participants in the intervention group receive conventional neurodevelopmental therapy combined with an elastic lower extremity orthosis designed to correct internal rotation deformities and improve gait and balance in children with spastic cerebral palsy. The orthosis applies elastic tension around the femoral region and tibia to target rotational problems.
BEHAVIORAL	Neurodevelopmental Therapy	Participants receive conventional neurodevelopmental therapy only.

Timeline

• Start date: 2025-08-25
• Primary completion: 2025-10-20
• Completion: 2025-11-01
• First posted: 2025-08-14
• Last updated: 2026-01-06

Locations

2 sites across 1 country: Turkey (Türkiye)