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

NCT06340425 | Completed

• 1 other identifier: s68727
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral palsy; Selective dorsal rhizotomy; Spasticity; Muscle morphology; Gait; Gross motor function; Clinical examination

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Overall change of spasticity in the plantar flexors

  pre- and one year post-SDR

• Overall change of selectivity in the plantar flexors

  pre- and one year post-SDR

• Overall change of passive range of motion in the ankle and knee joint

  pre- and one year post-SDR

• Overall change of muscle strength in the plantar flexors

  pre- and one year post-SDR

• Scatter plots of muscle morphology data (same parameters as for the primary endpoints)

  SDR (pre- and one year post-SDR )vs no SDR (a database of children with CP who were not treated with SDR, one timepoint)

Study Arms (2)

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).

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaat Desloovere, prof. dr.

  Department of Rehabilitation Sciences, KU Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: April 1, 2024
• Study Start: June 26, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

BE (1)