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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 Summary:

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 o
Sponsor: Shaare Zedek Medical Center

Current Primary Outcome: Quality of life [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 1. Hypertonia 2. Impairment measures 3. Upper extremity function 4. Function and patient needs assessment [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: Shaare Zedek Medical Center

Dates:
Date Received: October 24, 2007
Date Started: September 2007
Date Completion: September 2012
Last Updated: April 20, 2011
Last Verified: April 2011