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

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ClinicalTrials.gov Identifier: NCT03469999
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Heakyung Kim, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Drug: Dysport Injectable Product Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Single Event Multi Level Chemoneurolysis With Dysport on Energy Expenditure and Walking Efficiency
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dysport Injectable Product
All participants will participate in baseline data collection of energy expenditure, gait analysis, and lower limb spasticity assessment. All participants will receive single event multi level chemoneurolysis with Dysport and will have repeat data collection at 4 weeks and 12 weeks post injection.
Drug: Dysport Injectable Product
All participants will receive Dysport injection at multi levels in the spastic lower limb(s)
Other Name: Botulinum toxin A




Primary Outcome Measures :
  1. Change in Energy expenditure [ 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.


Secondary Outcome Measures :
  1. Change in Gait [ 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. Change in Muscle Spasticity [ 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 include 0, 1, 1+, 2, 3, and 4. A score of 0 indicates no increase in muscle tone/muscle spasticity and a score of 4 indicates a rigid muscle or maximum spasticity. A lower score after injection would indicate an improvement in muscle spasticity. The MAS will be performed in the hamstrings, gastrocnemius, and soleus muscles.

  3. Change in Muscle Spasticity [ Time Frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection ]
    The Modified Tardieu Scale measures muscle spasticity during a passive stretch at both slow and fast speeds. First measure determines the maximum range of motion of a target muscle group in degrees. 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. Change in Quality of Life [ Time Frame: Baseline (1 week prior to injection), 4 weeks post injection, 12 weeks post injection ]
    The Pediatrics Quality of Life Inventory (PedsQL) consists of 23 questions ranging from 0-4 with a higher score indicating a higher quality of life. The total score will be calculated as well as the four subscales: physical (8 items), emotional (5 items), social (5 items), and school functioning (5 items). After injection, a higher total score as well as in each subscale indicated an increase in quality of life.



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469999


Contacts
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Contact: Nancy Lee, MS 212-305-9416 nl2674@cumc.columbia.edu
Contact: Heakyung Kim, MD 212-305-5337 hk2641@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Heakyung Kim, MD    212-342-1395    hk2641@cumc.columbia.edu   
Contact: Nancy Lee, MS    212-305-9416    nl2674@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Heakyung Kim, MD Columbia University Medical Center- Department of Rehabilitation
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Responsible Party: Heakyung Kim, A. David Gurewitsch Professor of Rehabilitation and Regenerative Medicine and Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT03469999    
Other Study ID Numbers: AAAR1322
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Heakyung Kim, Columbia University:
Botulinum toxin A
Walking efficiency
Spasticity
Dysport
Pediatric
Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs