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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2025-11-01

Brief Summary

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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.

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Detailed Description

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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

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Spastic Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group: Neurodevelopmental Therapy

Participants receive conventional neurodevelopmental therapy only.

Group Type ACTIVE_COMPARATOR

Neurodevelopmental Therapy

Intervention Type BEHAVIORAL

Participants receive conventional neurodevelopmental therapy only.

Intervention Group: Therapy + Elastic Orthosis

Participants receive conventional neurodevelopmental therapy plus elastic lower extremity orthosis.

Group Type EXPERIMENTAL

Elastic Lower Extremity Orthosis

Intervention Type DEVICE

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.

Neurodevelopmental Therapy

Intervention Type BEHAVIORAL

Participants receive conventional neurodevelopmental therapy only.

Interventions

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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.

Intervention Type DEVICE

Neurodevelopmental Therapy

Participants receive conventional neurodevelopmental therapy only.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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