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NCT Number: NCT07122362

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

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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Key information

Conditions

Spastic Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

18 month–84 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, Ankara, Turkey, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elastic Lower Extremity Orthosis

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

Behavioral

Participants receive conventional neurodevelopmental therapy only.

Primary outcomes

  1. Gait parameters assessed by Edinburgh Visual Gait Analysis

    Time frame: 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 outcomes

  1. Balance parameters assessed by Pediatric Balance Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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