Spastic Cerebral PalsyNCT06355869
Repeatability of Gait Deviations in Children With Cerebral Palsy
An observational study of Spastic Cerebral Palsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. Gait variability can arise from intrinsic and extrinsic factors and may vary between walking conditions. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- repeated 3D gait-analysis
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Aug 2021to 31 May 2023
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Ambulant children with cerebral palsy between 6 and 17 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care.
Who may be able to join
- Gross Motor Function Classification System (GMFCS) level I - III
- CP (bilateral \& unilateral)
- Age: 6 - 17 years
- Prescribed AFO by the medical team (as part of the standard care)
Who cannot join
- Severe contractures or spasticity, which makes it impossible to wear a conventional AFO
- Cognitive or visual impairment that hinder them to understand instructions
- Previous surgery on bones and/or muscles of the legs in the last 12 months prior to assessment
- Presence of ataxia or dystonia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repeatability of Gait of Children With Spastic Cerebral Palsy in Different Walking Conditions
Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. Gait variability can arise from intrinsic and extrinsic factors and may vary between walking conditions. This study aimed to define the inter-trial (intrinsic) and inter-session (extrinsic) repeatability in gait analysis data of children with CP who were walking in four conditions, namely barefoot or with ankle-foot orthosis, and overground or treadmill.
Read the detailed description
With a prevalence of two to three per 1000 live births, Cerebral Palsy (CP) is the most common motor disability of childhood. Improving disturbed gait in ambulatory children with CP is an important treatment goal because it is associated with functional independence and participation of children in the society. It is a common practice to prescribe ankle-foot orthoses (AFO) for ambulatory children to improve their gait, prevent secondary deformities, provide an improved base of support, and compensate for muscle weakness.
Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. However, gait variability can arise from intrinsic (i.e., caused by the person's natural gait variability) and extrinsic (i.e., methodological sources, such as marker placement errors) factors and may vary between walking conditions. Follow-up and/or pre- and post-intervention 3DGA's are used to determine the treatment for these children with CP. So, it is important to know when differences between 3DGA's can be seen as 'true differences' or when the difference can be explained by intrinsic/extrinsic gait variability.
The purpose of the current study is to quantify the repeatability of gait in children with CP. Therefore, the repeatability between two 3DGA's that are performed at the Clinical Motion Analysis Laboratory (CMAL) of UZ Leuven will be assessed, following the standard 3DGA procedure that is applied at CMAL for routine clinical follow-up.
On the first test day, subjects will first receive a standard clinical examination preceding the clinical overground 3DGA that is planned as a routine clinical follow-up at the CMAL, extended with an additional 3DGA on the treadmill. The treadmill gait laboratory and overground gait laboratory are across the hall from each other, which makes it possible for the subject to walk from one to the other gait laboratory in just a minute.
On the second test day, a repeated 3DGA overground and on the treadmill will be performed by the same clinician. This involved clinical assessor is well-trained to perform 3GDA in children with CP.
Between the measurements, a period from 1 - 14 days is foreseen. The combinations of repeated gait trials per test day, and the repeated test days, with involvement of only one assessor, facilitates the distinction between intrinsic and extrinsic variability.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- repeated 3D gait-analysis
- Keywords
- Cerebral Palsy, Rehabilitation, Gait analysis, Variability
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated 3D gait-analysisOther
An observational 3D gait-analysis was performed with a period of 1-14 days is foreseen between the two measurements.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory children with spastic CP | Ambulant children with cerebral palsy between 6 and 17 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care. Receives: Other: repeated 3D gait-analysis | |
| TD children | Our TD-database of the Clinical Motion Analysis Laboratory (CMAL) of UZ Leuven was used for the calculation of the gait indices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The standard error of measurement (SEM) of the continuous kinematic gait waveforms
The SEM, is the standard deviation of a number of measurements made on the same participant.
SEM= √((∑▒〖deviations^2 〗)/(degrees of freedom)). The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement. This characteristic makes the use of SEM particularly clinically relevant. The SEM was used as a statistical analysis for determining the inter-trial and -session variability of the kinematic continuous waveforms in the sagittal plane of the hip, knee and ankle joint. Thereby, the SEM was calculated timepoint-by-timepoint from the continues waveforms, according to the methods of Schwartz et al. [4]
Measured: A period of 1-14 days is foreseen between the two measurements (3DGA)
The intra-class correlation (ICC) of the gait indices
The inter-trial and -session variability was defined by the use of the intra-class correlation coefficient (ICC; 2,1) (two-way random model with absolute agreement), along with the 95% confidence interval of the gait indices (i.e., the gait profile score and the gait variable score of the hip flexion, the knee flexion and the ankle dorsiflexion).
Measured: A period of 1-14 days is foreseen between the two measurements (3DGA)
The standard error of measurement (SEM) of the continuous kinetic gait waveforms
The SEM, is the standard deviation of a number of measurements made on the same participant.
SEM= √((∑▒〖deviations^2 〗)/(degrees of freedom)). The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement. This characteristic makes the use of SEM particularly clinically relevant. The SEM was used as a statistical analysis for determining the inter-trial and -session variability of the kinetic continuous waveforms (i.e., moments \& powers) in the sagittal plane of the hip, knee and ankle joint. Thereby, the SEM was calculated timepoint-by-timepoint from the continues waveforms, according to the methods of Schwartz et al. [4]
Measured: A period of 1-14 days is foreseen between the two measurements (3DGA)
The standard error of measurement (SEM) of the gait indices
The SEM, is the standard deviation of a number of measurements made on the same participant. SEM= SD x √(1-ICC), where SD is the standard deviation of the grand mean (mean of session 1 and session 2) from all participants. The SEM was calculated for the gait indices (i.e., the gait profile score and the gait variable score of the hip flexion, the knee flexion and the ankle dorsiflexion).
The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement, which makes the use of SEM particularly clinically relevant.
Measured: A period of 1-14 days is foreseen between the two measurements (3DGA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start17 Aug 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaat Desloovere, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Kaat Desloovere, prof. dr., Principal investigator, Department of Rehabilitation Sciences, KU Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355869
- Sponsor's protocol ID
- s65337
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.
PubMed 27188686Sankar C, Mundkur N. Cerebral palsy-definition, classification, etiology and early diagnosis. Indian J Pediatr. 2005 Oct;72(10):865-8. doi: 10.1007/BF02731117.
PubMed 16272660Morris C, Bowers R, Ross K, Stevens P, Phillips D. Orthotic management of cerebral palsy: recommendations from a consensus conference. NeuroRehabilitation. 2011;28(1):37-46. doi: 10.3233/NRE-2011-0630.
PubMed 21335676Schwartz MH, Trost JP, Wervey RA. Measurement and management of errors in quantitative gait data. Gait Posture. 2004 Oct;20(2):196-203. doi: 10.1016/j.gaitpost.2003.09.011.
PubMed 15336291Everaert L, Dewit T, Huenaerts C, Van Campenhout A, Labey L, Desloovere K. Repeatability of gait of children with spastic cerebral palsy in different walking conditions. J Biomech. 2024 Nov;176:112301. doi: 10.1016/j.jbiomech.2024.112301. Epub 2024 Aug 31.
PubMed 39265255
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability of Gait of Children With Spastic Cerebral Palsy in Different Walking Conditions
- ClinicalTrials.gov ID
- NCT06355869
- Acronym / sponsor ID
- s65337
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Cerebral Palsy, Rehabilitation, Gait analysis, Variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 10 Apr 2024 (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.
Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. Gait variability can arise from intrinsic and extrinsic factors and may vary between walking conditions. This study aimed to define the inter-trial (intrinsic) and inter-session (extrinsic) repeatability in gait analysis data of children with CP who were walking in four conditions, namely barefoot or with ankle-foot orthosis, and overground or treadmill.
Detailed description
With a prevalence of two to three per 1000 live births, Cerebral Palsy (CP) is the most common motor disability of childhood. Improving disturbed gait in ambulatory children with CP is an important treatment goal because it is associated with functional independence and participation of children in the society. It is a common practice to prescribe ankle-foot orthoses (AFO) for ambulatory children to improve their gait, prevent secondary deformities, provide an improved base of support, and compensate for muscle weakness.
Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. However, gait variability can arise from intrinsic (i.e., caused by the person's natural gait variability) and extrinsic (i.e., methodological sources, such as marker placement errors) factors and may vary between walking conditions. Follow-up and/or pre- and post-intervention 3DGA's are used to determine the treatment for these children with CP. So, it is important to know when differences between 3DGA's can be seen as 'true differences' or when the difference can be explained by intrinsic/extrinsic gait variability.
The purpose of the current study is to quantify the repeatability of gait in children with CP. Therefore, the repeatability between two 3DGA's that are performed at the Clinical Motion Analysis Laboratory (CMAL) of UZ Leuven will be assessed, following the standard 3DGA procedure that is applied at CMAL for routine clinical follow-up.
On the first test day, subjects will first receive a standard clinical examination preceding the clinical overground 3DGA that is planned as a routine clinical follow-up at the CMAL, extended with an additional 3DGA on the treadmill. The treadmill gait laboratory and overground gait laboratory are across the hall from each other, which makes it possible for the subject to walk from one to the other gait laboratory in just a minute.
On the second test day, a repeated 3DGA overground and on the treadmill will be performed by the same clinician. This involved clinical assessor is well-trained to perform 3GDA in children with CP.
Between the measurements, a period from 1 - 14 days is foreseen. The combinations of repeated gait trials per test day, and the repeated test days, with involvement of only one assessor, facilitates the distinction between intrinsic and extrinsic variability.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory children with spastic CP | – | Other: repeated 3D gait-analysisAmbulant children with cerebral palsy between 6 and 17 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care. |
| TD children | – | –Our TD-database of the Clinical Motion Analysis Laboratory (CMAL) of UZ Leuven was used for the calculation of the gait indices. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Ambulant children with cerebral palsy between 6 and 17 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care.
Key inclusion criteria (4 listed)
- Gross Motor Function Classification System (GMFCS) level I - III
- CP (bilateral \& unilateral)
- Age: 6 - 17 years
- Prescribed AFO by the medical team (as part of the standard care)
Key exclusion criteria (4 listed)
- Severe contractures or spasticity, which makes it impossible to wear a conventional AFO
- Cognitive or visual impairment that hinder them to understand instructions
- Previous surgery on bones and/or muscles of the legs in the last 12 months prior to assessment
- Presence of ataxia or dystonia
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 |
|---|---|---|
| repeated 3D gait-analysisAn observational 3D gait-analysis was performed with a period of 1-14 days is foreseen between the two measurements. | Other | Ambulatory children with spastic CP |
Primary outcome
The standard error of measurement (SEM) of the continuous kinematic gait waveforms
Time frame: A period of 1-14 days is foreseen between the two measurements (3DGA)
The SEM, is the standard deviation of a number of measurements made on the same participant. SEM= √((∑▒〖deviations^2 〗)/(degrees of freedom)). The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement. This characteristic makes the use of SEM particularly clinically relevant. The SEM was used as a statistical analysis for determining the inter-trial and -session variability of the kinematic continuous waveforms in the sagittal plane of the hip, knee and ankle joint. Thereby, the SEM was calculated timepoint-by-timepoint from the continues waveforms, according to the methods of Schwartz et al. [4]
The intra-class correlation (ICC) of the gait indices
Time frame: A period of 1-14 days is foreseen between the two measurements (3DGA)
The inter-trial and -session variability was defined by the use of the intra-class correlation coefficient (ICC; 2,1) (two-way random model with absolute agreement), along with the 95% confidence interval of the gait indices (i.e., the gait profile score and the gait variable score of the hip flexion, the knee flexion and the ankle dorsiflexion).
The standard error of measurement (SEM) of the continuous kinetic gait waveforms
Time frame: A period of 1-14 days is foreseen between the two measurements (3DGA)
The SEM, is the standard deviation of a number of measurements made on the same participant. SEM= √((∑▒〖deviations^2 〗)/(degrees of freedom)). The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement. This characteristic makes the use of SEM particularly clinically relevant. The SEM was used as a statistical analysis for determining the inter-trial and -session variability of the kinetic continuous waveforms (i.e., moments \& powers) in the sagittal plane of the hip, knee and ankle joint. Thereby, the SEM was calculated timepoint-by-timepoint from the continues waveforms, according to the methods of Schwartz et al. [4]
The standard error of measurement (SEM) of the gait indices
Time frame: A period of 1-14 days is foreseen between the two measurements (3DGA)
The SEM, is the standard deviation of a number of measurements made on the same participant. SEM= SD x √(1-ICC), where SD is the standard deviation of the grand mean (mean of session 1 and session 2) from all participants. The SEM was calculated for the gait indices (i.e., the gait profile score and the gait variable score of the hip flexion, the knee flexion and the ankle dorsiflexion). The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement, which makes the use of SEM particularly clinically relevant.
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 15 Apr 2024.
- Background: PubMed 27188686Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.
- Background: PubMed 16272660Sankar C, Mundkur N. Cerebral palsy-definition, classification, etiology and early diagnosis. Indian J Pediatr. 2005 Oct;72(10):865-8. doi: 10.1007/BF02731117.
- Background: PubMed 21335676Morris C, Bowers R, Ross K, Stevens P, Phillips D. Orthotic management of cerebral palsy: recommendations from a consensus conference. NeuroRehabilitation. 2011;28(1):37-46. doi: 10.3233/NRE-2011-0630.
- Background: PubMed 15336291Schwartz MH, Trost JP, Wervey RA. Measurement and management of errors in quantitative gait data. Gait Posture. 2004 Oct;20(2):196-203. doi: 10.1016/j.gaitpost.2003.09.011.
- Derived from this study: PubMed 39265255Everaert L, Dewit T, Huenaerts C, Van Campenhout A, Labey L, Desloovere K. Repeatability of gait of children with spastic cerebral palsy in different walking conditions. J Biomech. 2024 Nov;176:112301. doi: 10.1016/j.jbiomech.2024.112301. Epub 2024 Aug 31.
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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.
Kaat Desloovere, prof. dr. principal investigator
Department of Rehabilitation Sciences, KU Leuven, Belgium
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 Spastic Cerebral Palsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 4 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 15 Apr 2024. 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 Belgium. 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?
The standard error of measurement (SEM) of the continuous kinematic gait waveforms (time frame: A period of 1-14 days is foreseen between the two measurements (3DGA)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06355869, which also lists 5 linked publications.
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 15 Apr 2024.