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Completed

NCT Number: NCT03469999

Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy

This study aims to evaluate the efficacy of single event multi level chemoneurolysis with the abobotulinumtoxin A drug, Dysport®, on walking energy expenditure and gait in children with spastic diplegia cerebral palsy.

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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–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

Cerebral Palsy (CP) is the leading cause of disability in children, with the most widespread type of CP being spastic CP which negatively affects physical function. Specifically it is reported that there is an increase in energy expenditure and oxygen consumption in children with CP. Single event multi level chemoneurolysis with abobotulinumtoxinA has been found to be an effective treatment for patients with spasticity to reduce energy expenditure by increasing walking efficiency; however many of these studies have conflicting methodological approaches. Therefore this study aims to evaluate the single event multilevel chemoneurolysis with Dysport® on energy expenditure and gait in children with spastic diplegia CP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 5-17 years. Must be <18 prior to injection.
  • >10 kilograms at screening and injection visits
  • Diagnosis of spastic diplegia or mild- to moderate spastic quadriplegia Cerebral Palsy
  • Gross Motor Function Classification System level: I, II, III
  • Ability to ambulate independently without aid, equinus gait
  • Absent of joint or bone deformities
  • Eligible to receive single-event multi-level chemoneurolysis (SEMLC)
  • Cooperative and tolerant to testing procedures during clinic screening
  • Presence of spasticity in one or both legs
  • Be on a stable dose and regimen if on any prescribed medication/s
  • Parent must have signed written informed consent and the Patient Authorization for Use and Release of Health and Research Study Information

Exclusion criteria

  • Ankle contractures no more than -10 degrees with the knee extended
  • Hemiplegia
  • Wheelchair dependent
  • Received Botulinum toxin within previous 4 months
  • Uncontrolled epilepsy or certain types of seizures
  • Fracture in the study limb within previous 12 months
  • Infection or skin disorder at planned injection site
  • Shortness of breath or other respiratory issues
  • Uncontrolled clinically significant medical condition
  • Received phenol or alcohol block in the study limb within previous 6 months
  • Surgery in the study limb within previous 12 months
  • Serial casting within previous 12 months
  • New physiotherapy and/or orthotic regimen <1 month before study start. (physiotherapy and/or orthotic regimen will be permitted if it began >1 month before study start and maintained throughout study)

Treatment and study plan

Dysport Injectable Product

Drug

Selected dose of medication will be determined by affected muscle(s), severity of spasticity, and the patient's body weight. We will follow the recommended total Dysport dose of 10-15 units/kg per limb, not to exceed 15 units/kg for unilateral lower limb, 30 units/kg for bilateral lower limb, or a total of 1000 units, whichever is lower in a given session.

Other names: Botulinum toxin A

Primary outcomes

  1. Oxygen Consumption (ml/kg/Min)

    Time frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection

    Energy expenditure (oxygen consumption (VO2)) will be measured during the 6 minute walk test using a portable metabolic cart. The participants will use a 10 meter walkway to walk back and forth during the 6 minutes to coverage as much distance as possible. During this time they will be wearing a portable spirometric device that collects the oxygen consumption (VO2) per minute.

Secondary outcomes

  1. Gait Velocity (cm/s)

    Time frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection

    Gait analysis will be measured by the GaitMat system while the child walks on the mat back and forth for five trials.

  2. Muscle Spasticity Using MAS

    Time frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection

    The Modified Ashworth Scale (MAS) measures muscle spasticity during passive stretching. Scores are on a 6-point scale and include 0, 1, 1+, 2, 3, and 4. Scores range from 0 (better outcome), which indicates no increase in muscle tone/muscle spasticity to a score of 4 (worse outcome), which indicates a rigid muscle or maximum spasticity. Each subscale is independently scored and not combined to create a composite score. When calculating the mean score, 1+ is equivalent to a value of 1.5.

  3. Muscle Spasticity Using MTS

    Time frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection

    The Modified Tardieu Scale (MTS) measures muscle spasticity during a passive stretch at both slow and fast speeds. Scores range from 0, which indicates no resistance throughout the course of the passive movement (better outcome), to 5, which indicates that the joint is immovable (worse outcome). The first measure determines the maximum range of motion of a target muscle group in degrees and the second measure determines the angle where muscle resistance is felt during a rapid velocity stretch, recorded in degrees. The total score is calculated by subtracting measure one from measure two. A greater difference between measures indicates less muscle spasticity. The Modified Tardieu Scale will be performed in the hamstrings, gastrocnemius, and soleus muscles.

  4. Score on the Cerebral Palsy Quality of Life (CP QOL) Questionnaire

    Time frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection

    The Cerebral Palsy Quality of Life (CP QOL) Questionnaire consists of 66 items ranging from 1 to 9 with a lower score indicating a higher quality of life. The total score will be calculated as well as an individual score for the seven subscale domains: Social well-being and acceptance, functioning, Participation and physical health, Emotional well-being, Access to services, pain and feeling about disability, and family health. Scoring involves 2 steps. First, items are transformed to a scale with a possible range of 0-100. The scores are recoded as follows 1 to 0, 2 to 12.5, 3 to 25, 4 to 37.5, 5 to 50, 6 to 6.2, 7 to 75, 8 to 87.5, 9 to 100. Then the algebraic mean of item values is computed from the composite score for each domain. Once rescored, the final score ranges from 0 to 100, with 0 indicating a worse outcome.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Effect of Single Event Multi Level Chemoneurolysis With Dysport on Energy Expenditure and Walking Efficiency

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2018
Registry last updated
Jun 1, 2022

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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