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NCT Number: NCT06340425

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

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Key information

Conditions

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

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Overall change of spasticity in the plantar flexors

    Time frame: pre- and one year post-SDR

    Evaluation of spasticity of the plantar flexors, measured with the Modified Ashworth Scale.

  2. Overall change of selectivity in the plantar flexors

    Time frame: pre- and one year post-SDR

    Evaluation of selectivity of the plantar flexors, measured with the selective motor control test.

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

    Time frame: pre- and one year post-SDR

    Evaluation of passive range of motion in the ankle and knee joint, measured by goniometry.

  4. Overall change of muscle strength in the plantar flexors

    Time frame: pre- and one year post-SDR

    Evaluation of muscle strength of the plantar flexors, measured with the Medical Research Council Scale.

  5. 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)

    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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2024
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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