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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
26
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.
Participants receive conventional neurodevelopmental therapy only.
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, Ankara, Turkey
Ankara, Ankara, Turkey (Türkiye)
Niğde Ömer Halisdemir University Bor Physical Therapy and Rehabilitation Training and Research Hospital
Niğde, Niğde Province, Turkey (Türkiye)
Gait parameters assessed by Edinburgh Visual Gait Analysis
The Edinburgh Visual Gait Analysis Scale will be used to assess changes in gait patterns before and after the intervention. This scale consists of 17 items. Each item is scored between 0 and 2. A total score closer to zero indicates improved gait. The Edinburgh Visual Gait Analysis Scale was developed to quantitatively analyze gait parameters at different stages in recorded videos. During the assessment, children will be videotaped walking on a flat surface with their lower extremities bare. These recordings will assess each lower extremity during the stance and swing phases of gait.
Time frame: Baseline and 8 weeks after intervention
Balance parameters assessed by Pediatric Balance Scale
The Pediatric Balance Scale will be used to assess balance performance and changes in balance ability at baseline and 8 weeks after the intervention. The 14-item Pediatric Balance Scale is a functional balance measurement tool adapted for the pediatric population and allows for the assessment of balance in various positions and during movement; each item is scored from 0 to 4, with the highest possible score being 56. A higher score indicates better balance.
Time frame: Baseline and 8 weeks after intervention
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