An observational study in Unilateral Cerebral Palsy, sponsored by National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu. Completed at 1 site in Romania. Open to participants aged 11 Months to 42 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu · Observational
This study goal was to assess the evolution of spatio-temporal and kinematic gait parameters in toddlers with unilateral cerebral palsy (UCP) receiving standard rehabilitation during the first 18 months after gait acquisition and to compare their gait characteristics with those of typically developing (TD) children. The hypothesis is that the biomechanical parameters of newly acquired gait of children with UCP and their differences compared to TD toddlers with the same walking experience will change over time.
This is a observational prospective case-control study conducted between January 2022 and October 2024 in the Motion Analysis Laboratory of the National NeuroRehabilitation Center for Children (NRCC) " Robanescu- Padure" (former National Clinical Center for Neuropsychomotor Recovery for children "Dr.N. Robanescu") , Bucharest (Romania). The toddlers with UCP were recruited among the inpatients and outpatients of the Pediatric Rehabilitation department. TD toddlers were recruited among the siblings of the toddlers with UCP and the children of people known to the investigators. Toddlers from both groups were younger than 3 years old and independent walking experience of maximum 6 months.
The protocol involved two assessment sessions. The first gait analysis corresponded to baseline evaluation (T1), while the second assessment (T2) was performed 12-18 months later. Owing to difficulties in follow-up of several TD participants, mainly because of family-related constraints or failure to continue meeting inclusion criteria (e.g., emergence of gait abnormalities), the TD cohort at T2 was supplemented with children demonstrating typical development, aged up to 42 months and presenting 12-24 months of walking experience, in order to provide a control group for the follow-up assessment. Before T2 recordings, all exclusion criteria were reassessed in both groups. The sessions were performed by the same experienced assessor. The toddlers walked barefoot at self-selected pace. Each toddler was equipped with 19 reflective markers. Data was collected with a BTS motion capture system equipped with 12 infrared cameras. The biomechanical model used was "Helen Hayes with medial markers". Visual 3D software (C-motion, Rockville, MD, USA) was used to build the kinematic model and identify gait cycles.
A qualitative analysis was conducted for each gait cycle and each child in order to exclude the cycles during running or non-straight walking. Straight-line gait cycles were defined as cycles performed within a corridor width not exceeding 60 cm for at least two consecutive cycles. Data were retained only when a minimum of five gait cycles per limb and per session were available, with preference given to consecutive cycles. Data was filtered and normalized. The Gait profile score was calculated. For TD toddlers, a single value was reported as the mean for the right and left sides.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's enrollment of 78 is above the median of 63 across 472 observational studies indexed under Cerebral Palsy.
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The study population consisted of children with the unilateral cerebral palsy and typical developing children recruited as controls. Participants underwent instrumented gait analysis at baseline (T1), with a planned reassessment 12-18 months later (T2). In children with the studied pathology, gait analysis was performed as part of their standard clinical assessment, whereas healthy controls underwent gait analysis for study purposes.
Inclusion Criteria:
The following eligibility criteria applied to both groups at T1:
Exclusion Criteria for both assessment time points:
Children with unilateral cerebral palsy and maximum 6 months of independent walking underwent instrumented gait analysis as part of their standard clinical assessment. Participants were evaluated at baseline (T1) and were planned to undergo a repeat gait analysis 12-18 months later (T2).
Other: gait analysis
Children with typical development and maximum 6 months of independent walking were recruited as a control group for comparison with the UCP group. The toddlers from the control group were initially recruited at baseline (T1) and were planned to undergo repeat gait analysis approximately 12-18 months later. Due to limited availability for follow-up, only a proportion of the initially recruited controls returned for the T2 assessment. An additional group of healthy children with maximum age of 42 months and independent walking experience of 12-18 months was therefore recruited at T2 to provide a control sample for the follow-up assessment.
Other: gait analysis
Gait analysis using a 3D optoelectronic system
Changes in Three-Dimensional Gait Kinematics From Baseline to Follow-Up within the UCP group
Changes in continuous kinematic waveforms throughout the gait cycle, expressed as joint angles in degrees, assessed by three-dimensional gait analysis and compared between baseline (T1) and follow-up (T2). The assessed variables include pelvic, hip, knee, and ankle angles in the sagittal plane; pelvic and hip angles in the frontal and transverse planes; and the foot progression angle. Differences between assessments will be evaluated using Statistical Parametric Mapping (SPM) in children with unilateral cerebral palsy (UCP), separately for the affected and non-affected sides.
Time frame: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1.
Changes in Spatiotemporal Gait Parameters From Baseline to Follow-Up within the UCP group
Changes in spatiotemporal gait parameters assessed by three-dimensional gait analysis and compared between baseline (T1) and follow-up (T2). The assessed parameters include normalized gait velocity, cadence (stride per minute), gait cycle duration (s), the duration of stance, swing, single-support, first and second double-support phases (% of the gait cycle), normalized stride length, normalized step length, step width (m). Changes in these parameters will be evaluated in children with unilateral cerebral palsy (UCP), separately for the affected and non-affected sides.
Time frame: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1
Change in Gait Profile Score (GPS) From Baseline to Follow-Up within the UCP group
The Gait Profile Score (GPS) is a composite index derived from three-dimensional gait analysis that quantifies the overall deviation of an individual's lower-limb and pelvic kinematic patterns from the mean kinematic patterns of a typically developing reference population. It is calculated as the root mean square average of the Gait Variable Scores (GVS), which quantify deviations in nine key kinematic variables throughout the gait cycle. The GPS is expressed in degrees (°). Higher GPS values indicate greater deviation from the typically developing reference gait pattern and poorer overall gait kinematic quality, whereas lower values indicate a gait pattern closer to the reference pattern. In this study, GPS values will be compared between baseline (T1) and follow-up (T2) in children with unilateral cerebral palsy (UCP), separately for the affected and non-affected sides.
Time frame: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1
Between-Group Differences in Gait Kinematics at Baseline and Follow-Up
Differences in three-dimensional gait kinematic waveforms between children with unilateral cerebral palsy (UCP) and typically developing (TD) children will be assessed separately at baseline (T1) and follow-up (T2). Kinematic variables include pelvic, hip, knee, and ankle angles in the sagittal plane; pelvic and hip angles in the frontal and transverse planes; and the foot progression angle. Kinematic waveforms will be compared throughout the gait cycle using Statistical Parametric Mapping (SPM). In the UCP group, the affected and non-affected sides will be analysed separately and compared with the representative side obtained by averaging the left and right sides in the TD group. Differences between groups will be evaluated at each assessment time point.
Time frame: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1.
Between-Group Differences in Spatiotemporal Gait Parameters at Baseline and Follow-Up
Differences in spatiotemporal gait parameters between children with unilateral cerebral palsy (UCP) and typically developing (TD) children will be assessed separately at baseline (T1) and follow-up (T2) using three-dimensional gait analysis. The assessed parameters include normalized gait velocity, cadence (stride per minute), gait cycle duration (s), the duration of stance, swing, single-support, first and second double-support phases (% of the gait cycle), normalized stride length, normalized step length, step width (m). In the UCP group, the affected and non-affected sides will be analysed separately and compared with the representative side obtained by averaging the left and right sides in the TD group. Between-group differences will be evaluated separately at T1 and T2.
Time frame: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1.
Between-Group Differences in Gait Profile Score at Baseline and Follow-Up
Differences in the Gait Profile Score (GPS) between children with unilateral cerebral palsy (UCP) and typically developing (TD) children will be assessed separately at baseline (T1) and follow-up (T2) using three-dimensional gait analysis. The GPS is a composite measure, expressed in degrees (°), that quantifies the overall deviation of an individual's gait kinematics from a typically developing reference gait pattern. It is derived from the root mean square average of the Gait Variable Scores (GVS), which quantify deviations in nine kinematic variables throughout the gait cycle. Higher GPS values indicate greater kinematic deviation, whereas lower values indicate a gait pattern closer to the reference pattern. In the UCP group, GPS values for the affected and non-affected sides will be analysed separately and compared with the representative side obtained by averaging the left and right sides in the TD group. Between-group differences will be evaluated separately at T1 and T2.
Time frame: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1.
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National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu