Spastic Cerebral Palsy
Conditions
Keywords
cerebral palsy, in-toeing gait, balance, orthoses, neoprene
Brief 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.
Interventions
DEVICEElastic 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.
BEHAVIORALNeurodevelopmental Therapy
Participants receive conventional neurodevelopmental therapy only.
Sponsors
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 84 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait parameters assessed by Edinburgh Visual Gait Analysis | Baseline and 8 weeks after intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance parameters assessed by Pediatric Balance Scale | Baseline and 8 weeks after intervention | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed