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

Gazi University

Status: Completed

Conditions: Spastic Cerebral Palsy

Treatments: Device: Elastic Lower Extremity Orthosis; Behavioral: Neurodevelopmental Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07122362

2024 - 587

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 84 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Control Group: Neurodevelopmental Therapy

Active Comparator group

Description:

Participants receive conventional neurodevelopmental therapy only.

Treatment:

Behavioral: Neurodevelopmental Therapy

Intervention Group: Therapy + Elastic Orthosis

Experimental group

Description:

Participants receive conventional neurodevelopmental therapy plus elastic lower extremity orthosis.

Treatment:

Behavioral: Neurodevelopmental Therapy

Device: Elastic Lower Extremity Orthosis