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Sponsored by: |
Shaare Zedek Medical Center |
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Information provided by: | Shaare Zedek Medical Center |
ClinicalTrials.gov Identifier: | NCT00549471 |
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.
Condition | Intervention | Phase |
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Cerebral Palsy |
Other: physiotherapy Other: Botulinum Toxin A and physiotherapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Improvement After Botulinum Toxin A Injections to the Upper Extremities in Children With Cerebral Palsy |
Estimated Enrollment: | 20 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2009 |
Arms | Assigned Interventions |
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BG: Experimental
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
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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.
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CG
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.
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Other: physiotherapy
CG children will undergo a program of intensive physiotherapy
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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 curical 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:
Ages Eligible for Study: | 8 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hilla Ben-Pazi, MD | 972-2-6666641 | benpazi@szmc.org.il |
Israel | |
Shaare Zedek Medical Center | Recruiting |
Jerusalem, Israel, 91031 | |
Contact: Hilla Ben-Pazi 972-2-6666641 benpazi@szmc.org.il | |
Sub-Investigator: Nava Gelkop |
Principal Investigator: | Hilla Ben-Pazi, MD | Shaare Zedek Medical Center |
Study ID Numbers: | 180907.ctil |
Study First Received: | October 24, 2007 |
Last Updated: | October 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00549471 History of Changes |
Health Authority: | Israel: Ministry of Health |
children with cerebral palsy ages eight to eleven. |
Paralysis Botulinum Toxins Cerebral Palsy Brain Damage, Chronic |
Central Nervous System Diseases Botulinum Toxin Type A Brain Diseases Brain Injuries |
Botulinum Toxins Cerebral Palsy Anti-Dyskinesia Agents Therapeutic Uses Nervous System Diseases |
Brain Damage, Chronic Central Nervous System Diseases Brain Diseases Central Nervous System Agents Pharmacologic Actions |