The Effect of Selective Dorsal Rhizotomy on a Multidimensional Outcome Set in Children With Spastic Cerebral Palsy: a Retrospective Study

Cerebral Palsy Clinical Trial

Official title:

The Effect of Selective Dorsal Rhizotomy on a Multidimensional Outcome Set in Children With Spastic Cerebral Palsy: a Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06340425
• Other study ID #: s68727
• Status: Completed
• Start date: June 26, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre- and one year post-SDR
Primary	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.	pre- and one year post-SDR
Primary	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.	pre- and one year post-SDR
Primary	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.	pre- and one year post-SDR
Primary	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.	pre- and one year post-SDR
Primary	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.	pre- and one year post-SDR
Secondary	Overall change of spasticity in the plantar flexors	Evaluation of spasticity of the plantar flexors, measured with the Modified Ashworth Scale.	pre- and one year post-SDR
Secondary	Overall change of selectivity in the plantar flexors	Evaluation of selectivity of the plantar flexors, measured with the selective motor control test.	pre- and one year post-SDR
Secondary	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.	pre- and one year post-SDR
Secondary	Overall change of muscle strength in the plantar flexors	Evaluation of muscle strength of the plantar flexors, measured with the Medical Research Council Scale.	pre- and one year post-SDR
Secondary	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.	SDR (pre- and one year post-SDR )vs no SDR (a database of children with CP who were not treated with SDR, one timepoint)