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

NCT ID: NCT06340425

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-26
• Study Completion Date: 2023-12-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Kaat Desloovere

prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaat Desloovere, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation Sciences, KU Leuven, Belgium

Locations

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

s68727

Identifier Type: -

Identifier Source: org_study_id