Cerebral PalsyNCT06340425
The Effect of Selective Dorsal Rhizotomy on a Multidimensional Outcome Set in Children With Spastic Cerebral Palsy: a Retrospective Study
An observational study of Cerebral Palsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Cerebral palsy or CP is the single largest cause of childhood physical disability, with a prevalence of 2-3 per 1000 livebirths. Children with CP experience different primary symptoms, including abnormal increased muscle tone or spasticity. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jun 2018to 31 Dec 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with spastic cerebral palsy, receiving SDR at the CP reference center of the University Hospitals Leuven and have clinical follow-up pre- and post-SDR at the Clinical Motion Analysis Laboratory Pellenberg (CMAL, UZ Leuven, Campus Pellenberg) Control groups: * Reference database of children with spastic cerebral palsy, without a SDR intervention * Reference database of typically developing children
Who may be able to join
- Spastic CP, Uni- or bilateral involvement
- Gross Motor Classification System (GMFCS) levels I to III
- Children: 5 to 16 years of age at time of SDR
- SDR intervention
- Clinical follow-up pre- and post-SDR at the Clinical Motion Analysis Laboratory Pellenberg (CMAL, UZ Leuven, Campus Pellenberg)
Who cannot join
- Presence of dystonia or ataxia
- SDR intervention in combination with muscle surgery
- Severe co-morbidities (that are likely to prevent proper assessment, such as severe cognitive problems)
Trial locations and contacts
1 site in 1 country.
About this study
Cerebral palsy or CP is the single largest cause of childhood physical disability, with a prevalence of 2-3 per 1000 livebirths. Children with CP experience different primary symptoms, including abnormal increased muscle tone or spasticity. Selective dorsal rhizotomy (SDR) is applied in children with spastic CP as a non-reversible tone reduction procedure. Better understanding of the effects of SDR on a multidimensional outcome set in one CP-cohort and on macroscopic muscle morphology can improve insights and clinical decision making.
Read the detailed description
Cerebral palsy or CP is the single largest cause of childhood physical disability, with a prevalence of 2-3 per 1000 livebirths. Children with CP experience different primary symptoms, including abnormal increased muscle tone or spasticity. Selective dorsal rhizotomy (SDR) is applied in children with spastic CP as a non-reversible tone reduction procedure. During this neurosurgical procedure, dorsal rootlets are transected to diminish the excitatory input from the afferents, resulting in a reduction of the abnormal, increased muscle tone. Although different studies investigated the SDR-effect on separate sets of outcomes, such as spasticity, gait or gross motor function, no study so far has studied SDR-effects on combined outcome sets in one CP-cohort or on macroscopic muscle morphology.
The discrepancy between results of different previous studies highlight the added value of a multidimensional outcome set assessed within one cohort. Integrating outcomes of different levels will provide a better insight on how effects do or do not occur. Additionally, although SDR does not directly intervene with the macroscopic muscle structures, reducing the excitatory input from the afferents could potentially have an effect on muscle growth. Indicating macroscopic muscle morphology as an important outcome.
The current study will investigate the added value of a multidimensional outcome set, assessed in one single cohort. Important gaps in the literature will be addressed, including the effect of SDR on muscle morphology and the use of instrumented assessments. The primary objective of this study was to investigate changes in a multidimensional outcome set (including spasticity, muscle morphology, gait and gross motor function) pre- and post-SDR, in one single cohort of children with spastic CP. As a secondary objective, this study will compare outcomes of the clinical examination (spasticity, range of motion, strength, selectivity) pre- and post-SDR. Additionally, muscle morphology will be qualitatively compared in children with CP who received an SDR to children with CP without an SDR intervention.
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Selective dorsal rhizotomy, Spasticity, Muscle morphology, Gait, Gross motor function, Clinical examination
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SDR group, main group will be evaluated within subject design | * Patient characteristics: Children with spastic cerebral palsy, 5 to 16 years of age at time of SDR, both male and female. All children were diagnosed with bilateral involvement, Gross Motor Function Classification System level II or III. * Intervention: All participants underwent an SDR procedure in terms of their clinical care, based on the clinical decision making of the attending physician. During the SDR procedure, 25-30% of the dorsal rootlets was cut, descending between L1 and S1. Children received an intensive one-year rehabilitation program after the procedure, of which two to three months of the rehabilitation was performed while the child was admitted to the hospital. The effects within the SDR group will be compared to two control groups (see below). | |
| Control groups | Additionally two reference databases, established during previous research, will be used to improve interpretation. A normative reference database of typically developing children will be used to calculate the three-dimensional gait analysis outcomes. This database consists of 87 typically developing children (aged between 4,5 and 18,5 years, 42 boys and 45 girls, weight range 17,6 and 92,5 kg, height range between 1,08 and 1,9 meter). A reference database of children with spastic CP without a SDR intervention will be used to qualitatively judge the muscle morphology of children with spastic CP with an SDR intervention. This database consists of 206 children with CP (aged between 0,6 and 17,4 years, 124 boys and 82 girls, weight range 5,8 and 82,0 kg, height range between 0,6 and 1,9 meter, 88 with unilateral and 118 with bilateral involvement, 104 with a GMFCS level 1, 63 with a level 2 and 39 with a level 3). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall changes in spasticity
The specific outcome is the difference in the root mean square value of the surface-EMG signals between the low- and high-velocity passive stretches, expressed both absolute and normalized to the maximum voluntary contraction.
Measured: pre- and one year post-SDR
Overall change in muscle volume of the medial gastrocnemius
Estimation of the muscle belly volume, measured by 3DfUS. Muscle volume will be expressed absolute and normalized to anthropometric growth.
Measured: pre- and one year post-SDR
Overall changes in muscle length of the medial gastrocnemius
Estimation of the muscle belly length, tendon length and muscle tendon unit complex length, measured by 3DfUS. Muscle lengths will be expressed absolute and normalized to anthropometric growth.
Measured: pre- and one year post-SDR
Overall changes in muscle cross-sectional area at 50% of muscle belly length
Estimation of the muscle belly cross-sectional area at 50% of the muscle belly length, measured by 3DfUS. Muscle cross-sectional area will be expressed absolute and normalized to anthropometric growth.
Measured: pre- and one year post-SDR
Overall changes in gait
Gait was measured with three-dimensional gait analysis. The specific outcomes are the gait profile score and the gait variable scores of the ankle and the knee. Parameters were calculated using the reference database of typically developing children.
Measured: pre- and one year post-SDR
Overall change in gross-motor function
Gross-motor function was measured with the Gross-motor function measure 66- item set, resulting in a total score.
Measured: pre- and one year post-SDR
Secondary outcomes (5)
Overall change of spasticity in the plantar flexors
Evaluation of spasticity of the plantar flexors, measured with the Modified Ashworth Scale.
Measured: pre- and one year post-SDR
Overall change of selectivity in the plantar flexors
Evaluation of selectivity of the plantar flexors, measured with the selective motor control test.
Measured: pre- and one year post-SDR
Overall change of passive range of motion in the ankle and knee joint
Evaluation of passive range of motion in the ankle and knee joint, measured by goniometry.
Measured: pre- and one year post-SDR
Overall change of muscle strength in the plantar flexors
Evaluation of muscle strength of the plantar flexors, measured with the Medical Research Council Scale.
Measured: pre- and one year post-SDR
Scatter plots of muscle morphology data (same parameters as for the primary endpoints)
Scatter plots of muscle morphology data per age, for the reference database of children with spastic cerebral palsy, without an SDR intervention, overlaid by the individual data points of the enrolled children with CP who did receive an SDR intervention, pre and 1 year post SDR.
Measured: SDR (pre- and one year post-SDR )vs no SDR (a database of children with CP who were not treated with SDR, one timepoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start26 Jun 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 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
- NCT06340425
- Sponsor's protocol ID
- s68727
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Selective Dorsal Rhizotomy on a Multidimensional Outcome Set in Children With Spastic Cerebral Palsy: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06340425
- Acronym / sponsor ID
- s68727
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Selective dorsal rhizotomy, Spasticity, Muscle morphology, Gait, Gross motor function, Clinical examination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 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.
Cerebral palsy or CP is the single largest cause of childhood physical disability, with a prevalence of 2-3 per 1000 livebirths. Children with CP experience different primary symptoms, including abnormal increased muscle tone or spasticity. Selective dorsal rhizotomy (SDR) is applied in children with spastic CP as a non-reversible tone reduction procedure. Better understanding of the effects of SDR on a multidimensional outcome set in one CP-cohort and on macroscopic muscle morphology can improve insights and clinical decision making.
Detailed description
Cerebral palsy or CP is the single largest cause of childhood physical disability, with a prevalence of 2-3 per 1000 livebirths. Children with CP experience different primary symptoms, including abnormal increased muscle tone or spasticity. Selective dorsal rhizotomy (SDR) is applied in children with spastic CP as a non-reversible tone reduction procedure. During this neurosurgical procedure, dorsal rootlets are transected to diminish the excitatory input from the afferents, resulting in a reduction of the abnormal, increased muscle tone. Although different studies investigated the SDR-effect on separate sets of outcomes, such as spasticity, gait or gross motor function, no study so far has studied SDR-effects on combined outcome sets in one CP-cohort or on macroscopic muscle morphology.
The discrepancy between results of different previous studies highlight the added value of a multidimensional outcome set assessed within one cohort. Integrating outcomes of different levels will provide a better insight on how effects do or do not occur. Additionally, although SDR does not directly intervene with the macroscopic muscle structures, reducing the excitatory input from the afferents could potentially have an effect on muscle growth. Indicating macroscopic muscle morphology as an important outcome.
The current study will investigate the added value of a multidimensional outcome set, assessed in one single cohort. Important gaps in the literature will be addressed, including the effect of SDR on muscle morphology and the use of instrumented assessments. The primary objective of this study was to investigate changes in a multidimensional outcome set (including spasticity, muscle morphology, gait and gross motor function) pre- and post-SDR, in one single cohort of children with spastic CP. As a secondary objective, this study will compare outcomes of the clinical examination (spasticity, range of motion, strength, selectivity) pre- and post-SDR. Additionally, muscle morphology will be qualitatively compared in children with CP who received an SDR to children with CP without an SDR intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDR group, main group will be evaluated within subject design | – | –* Patient characteristics: Children with spastic cerebral palsy, 5 to 16 years of age at time of SDR, both male and female. All children were diagnosed with bilateral involvement, Gross Motor Function Classification System level II or III. * Intervention: All participants underwent an SDR procedure in terms of their clinical care, based on the clinical decision making of the attending physician. During the SDR procedure, 25-30% of the dorsal rootlets was cut, descending between L1 and S1. Children received an intensive one-year rehabilitation program after the procedure, of which two to three months of the rehabilitation was performed while the child was admitted to the hospital. The effects within the SDR group will be compared to two control groups (see below). |
| Control groups | – | –Additionally two reference databases, established during previous research, will be used to improve interpretation. A normative reference database of typically developing children will be used to calculate the three-dimensional gait analysis outcomes. This database consists of 87 typically developing children (aged between 4,5 and 18,5 years, 42 boys and 45 girls, weight range 17,6 and 92,5 kg, height range between 1,08 and 1,9 meter). A reference database of children with spastic CP without a SDR intervention will be used to qualitatively judge the muscle morphology of children with spastic CP with an SDR intervention. This database consists of 206 children with CP (aged between 0,6 and 17,4 years, 124 boys and 82 girls, weight range 5,8 and 82,0 kg, height range between 0,6 and 1,9 meter, 88 with unilateral and 118 with bilateral involvement, 104 with a GMFCS level 1, 63 with a level 2 and 39 with a level 3). |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with spastic cerebral palsy, receiving SDR at the CP reference center of the University Hospitals Leuven and have clinical follow-up pre- and post-SDR at the Clinical Motion Analysis Laboratory Pellenberg (CMAL, UZ Leuven, Campus Pellenberg) Control groups: * Reference database of children with spastic cerebral palsy, without a SDR intervention * Reference database of typically developing children
Key inclusion criteria (5 listed)
- Spastic CP, Uni- or bilateral involvement
- Gross Motor Classification System (GMFCS) levels I to III
- Children: 5 to 16 years of age at time of SDR
- SDR intervention
- Clinical follow-up pre- and post-SDR at the Clinical Motion Analysis Laboratory Pellenberg (CMAL, UZ Leuven, Campus Pellenberg)
Key exclusion criteria (3 listed)
- Presence of dystonia or ataxia
- SDR intervention in combination with muscle surgery
- Severe co-morbidities (that are likely to prevent proper assessment, such as severe cognitive problems)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall changes in spasticity
Time frame: pre- and one year post-SDR
The specific outcome is the difference in the root mean square value of the surface-EMG signals between the low- and high-velocity passive stretches, expressed both absolute and normalized to the maximum voluntary contraction.
Overall change in muscle volume of the medial gastrocnemius
Time frame: pre- and one year post-SDR
Estimation of the muscle belly volume, measured by 3DfUS. Muscle volume will be expressed absolute and normalized to anthropometric growth.
Overall changes in muscle length of the medial gastrocnemius
Time frame: pre- and one year post-SDR
Estimation of the muscle belly length, tendon length and muscle tendon unit complex length, measured by 3DfUS. Muscle lengths will be expressed absolute and normalized to anthropometric growth.
Overall changes in muscle cross-sectional area at 50% of muscle belly length
Time frame: pre- and one year post-SDR
Estimation of the muscle belly cross-sectional area at 50% of the muscle belly length, measured by 3DfUS. Muscle cross-sectional area will be expressed absolute and normalized to anthropometric growth.
Overall changes in gait
Time frame: pre- and one year post-SDR
Gait was measured with three-dimensional gait analysis. The specific outcomes are the gait profile score and the gait variable scores of the ankle and the knee. Parameters were calculated using the reference database of typically developing children.
Overall change in gross-motor function
Time frame: pre- and one year post-SDR
Gross-motor function was measured with the Gross-motor function measure 66- item set, resulting in a total score.
5 secondary outcomes
Overall change of spasticity in the plantar flexors
Time frame: pre- and one year post-SDR
Overall change of selectivity in the plantar flexors
Time frame: pre- and one year post-SDR
Overall change of passive range of motion in the ankle and knee joint
Time frame: pre- and one year post-SDR
Overall change of muscle strength in the plantar flexors
Time frame: pre- and one year post-SDR
Scatter plots of muscle morphology data (same parameters as for the primary endpoints)
Time frame: SDR (pre- and one year post-SDR )vs no SDR (a database of children with CP who were not treated with SDR, one timepoint)
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 1 Apr 2024.
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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 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 5 inclusion and 3 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 1 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?
Overall changes in spasticity (time frame: pre- and one year post-SDR). The study lists 6 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 1 Apr 2024.