Unilateral Cerebral PalsyNCT07906223
Evolution of Gait Parameters in Toddlers With Unilateral Cerebral Palsy
An observational study of Unilateral Cerebral Palsy, run by National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu at 1 site in Romania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Cerebral Palsy
- What is being tested?
- gait analysis
- How many people
- 78 participants
- Where
- 1 siteRomania
- Study dates
- 17 Mar 2022to 16 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 42 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- The following eligibility criteria applied to both groups at T1:
- age below 3 years;
- no more than 6 months of independent walking experience;
- ability to walk at least 5 m independently, without external assistance or falls;
- the presence of right or left hemiparesis and a medical history compatible with cerebral palsy for UCP group;
- typical psychomotor development and acquisition of independent walking before 18 months of age for TD group.
Who cannot join
- previous lower-limb surgery;
- lower-limb trauma within the preceding 6 months;
- known allergy to adhesive materials;
- lower-limb botulinum toxin injections within the previous 3 months for the UCP group;
- the presence of neurological and/or orthopaedic disorders for the TD group.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution Of Gait Biomechanical Parameters In Toddlers With Unilateral Cerebral Palsy During The First 18 Months Of Independent Walking: A Comparison With Typically Developing Peers
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.
Read the detailed description
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.
- Conditions
- Unilateral Cerebral Palsy
- Being tested
- gait analysis
- Keywords
- gait, unilateral cerebral palsy, toddlers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait analysisOther
Gait analysis using a 3D optoelectronic system
| Study group | Role | What they receive |
|---|---|---|
| UCP children | 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). Receives: Other: gait analysis | |
| TD children | 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. Receives: Other: gait analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start17 Mar 2022
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Brest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906223
- Sponsor's protocol ID
- 4708
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution Of Gait Biomechanical Parameters In Toddlers With Unilateral Cerebral Palsy During The First 18 Months Of Independent Walking: A Comparison With Typically Developing Peers
- ClinicalTrials.gov ID
- NCT07906223
- Acronym / sponsor ID
- 4708
- Conditions
- Unilateral Cerebral Palsy
- Keywords
- gait, unilateral cerebral palsy, toddlers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae RobanescuUniversity, hospital or other
- Collaborators
- University Hospital, Brest
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCP children | – | Other: gait analysisChildren 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). |
| TD children | – | Other: gait analysisChildren 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. |
Who may qualify
- Ages
- 11 to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (6 listed)
- age below 3 years;
- no more than 6 months of independent walking experience;
- ability to walk at least 5 m independently, without external assistance or falls;
- the presence of right or left hemiparesis and a medical history compatible with cerebral palsy for UCP group;
- typical psychomotor development and acquisition of independent walking before 18 months of age for TD group.
Key exclusion criteria (5 listed)
- previous lower-limb surgery;
- lower-limb trauma within the preceding 6 months;
- known allergy to adhesive materials;
- lower-limb botulinum toxin injections within the previous 3 months for the UCP group;
- the presence of neurological and/or orthopaedic disorders for the TD group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gait analysisGait analysis using a 3D optoelectronic system | Other | TD children, UCP children |
Primary outcome
Changes in Three-Dimensional Gait Kinematics From Baseline to Follow-Up within the UCP group
Time frame: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1.
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.
Changes in Spatiotemporal Gait Parameters From Baseline to Follow-Up within the UCP group
Time frame: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1
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.
Change in Gait Profile Score (GPS) From Baseline to Follow-Up within the UCP group
Time frame: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1
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.
3 secondary outcomes
Between-Group Differences in Gait Kinematics at Baseline and Follow-Up
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
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
Time frame: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Unilateral Cerebral Palsy
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
RecruitingObservational study
Functional Benefits of Multisite Upper Limb Surgery in Children With Unilateral Cerebral Palsy (RETRO-CHIRc)
Cerebral Palsy, Hemiplegia
Not yet recruiting
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder
Not yet recruiting
Effect of Nordic Walking Versus Treadmill Training on Gait Asymmetry in Children With Unilateral Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Smartphone Accelerometry for Gait Analysis in Children With Unilateral Spastic Cerebral Palsy
Cerebral Palsy, Unilateral Spastic Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Cerebral Palsy, run by National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Three-Dimensional Gait Kinematics From Baseline to Follow-Up within the UCP group (time frame: T1: within the first 6 months after acquisition of independent walking; T2: 12-18 months after T1.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.