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Trial record 33 of 420 for:    shaare zedek

Improvement After Botulinum Toxin Injections to the Arms in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT00549471
Recruitment Status : Terminated (no funding)
First Posted : October 25, 2007
Last Update Posted : April 21, 2011
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE October 24, 2007
First Posted Date  ICMJE October 25, 2007
Last Update Posted Date April 21, 2011
Study Start Date  ICMJE September 2007
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2007)
Quality of life [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00549471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2007)
1. Hypertonia 2. Impairment measures 3. Upper extremity function 4. Function and patient needs assessment [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improvement After Botulinum Toxin Injections to the Arms in Children With Cerebral Palsy
Official Title  ICMJE Improvement After Botulinum Toxin A Injections to the Upper Extremities in Children With Cerebral Palsy
Brief Summary Hypothesis: (1) Treating upper limb hypertonia/spasticity with Botox®, in addition to reducing hypertonia/spasticity, will (a) improve global development, (b) improve function (passive & active), (c) reduce carer burden and (d) improve quality of life. (2) Early treatment with Botox® will have a greater impact on the rate of global development when compared to late treatment.
Detailed Description

Background: Upper limb function is essential for activities of daily living impacting on quality of life in children with cerebral palsy (CP). In preschool children, dysfunctional upper extremity manipulation not only leads to disability but may further delay global development and substantially increase career burden. Even modest functional improvement could have tremendous long-term benefit in activities of daily living and significantly reduce career burden. Hypertonia is the main symptom causing motor dysfunction in CP. Intramuscular Botulinum toxin injection is one way of treatment. In spite of anecdotal evidence suggesting that early intervention can lead to better outcomes, Israeli physicians are unable to prescribe this treatment for the upper extremities due to limited health insurance coverage. A paucity research evidence is often cited as the reason for limiting the insurance coverage, in particular to the upper limb. We therefore propose to study the effects of Botox® in treating children with CP.

Method: Twenty cooperative quadriplegic CP children ages 8-11 years, gross motor function level 4, will be enrolled for the study. Inclusion criteria will be troublesome hypertonia that will respond to treatment with Botox® (as identified by clinical assessment and neurophysiological measures). Since cooperation is crucial for the intensive therapy children with cognitive impairment (IQ<70) or severe behavioural disorders will be excluded. The children will be randomized to one of two groups a Botox group (BG) and a control group (CG). CG children will undergo a program of intensive therapy and BG children will be given Botox, as clinically required, in addition to an equivalent program of intensive therapy. Botox injection will be tailored according to the specific child. Generally injection site will include biceps and brachioradialis , while flexors of the wrist and digits will be injected according to abnormal postures during function. Maximal total dose will be 23 IU per kg. The intensive therapy will be as clinically required and the therapy program will be fully documented.

Outcome measures will include the following:

  1. Hypertonia- neurophysiological measures
  2. Impairment measures - Grip and Pinch strength, active and passive range of motion at the writs elbow and shoulder
  3. Upper extremity function - Quality of Upper Extremity Skills Test (QUEST), Box and Blocks test
  4. Function and patient needs assessment - Goal Attainment Scores, Developmental Fine Motor Scale, Pediatric Evaluation and Disability Inventory (PEDI)
  5. Quality of life scales (care and comfort hypertonicity questionnaire) All of these measures will be taken once before treatment and then repeated at 7 months, and at 13 months after treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE
  • Other: physiotherapy
    CG children will undergo a program of intensive physiotherapy
  • Other: Botulinum Toxin A and physiotherapy
    BG children will be given Botox, as clinically required, in addition to an equivalent program of intensive therapy. Botox injection will be tailored according to the specific child. Generally injection site will include biceps and brachioradialis, while flexors of the wrist and digits will be injected according to abnormal postures during function. Maximal total dose will be 23 IU per kg.
Study Arms  ICMJE
  • Experimental: BG
    cooperative quadriplegic CP children ages 8-11 years, gross motor function level 4 with troublesome hypertonia that will respond to treatment. BG children will be given Botulinum Toxin A, as clinically required, in addition to an equivalent program of intensive therapy
    Intervention: Other: Botulinum Toxin A and physiotherapy
  • No Intervention: Control Group
    control group: Twenty cooperative quadriplegic CP children ages 8-11 years, gross motor function level 4 with troublesome hypertonia that will respond to treatment.CG children will undergo a program of intensive therapy.
    Intervention: Other: physiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 20, 2011)
3
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2007)
20
Estimated Study Completion Date  ICMJE September 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • cooperative quadriplegic CP children
  • gross motor function level 4
  • troublesome hypertonia that will respond to treatment with Botox

Exclusion Criteria:

  • cognitive impairment (IQ<70)
  • severe behavioural disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00549471
Other Study ID Numbers  ICMJE 180907.ctil
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Van Dayk, Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hilla Ben-Pazi, MD Shaare Zedek Medical Center
PRS Account Shaare Zedek Medical Center
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP