Improvement After Botulinum Toxin Injections to the Arms in Children With Cerebral Palsy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00549471|
Recruitment Status : Terminated (no funding)
First Posted : October 25, 2007
Last Update Posted : April 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Other: physiotherapy Other: Botulinum Toxin A and physiotherapy||Phase 4|
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:
- Hypertonia- neurophysiological measures
- Impairment measures - Grip and Pinch strength, active and passive range of motion at the writs elbow and shoulder
- Upper extremity function - Quality of Upper Extremity Skills Test (QUEST), Box and Blocks test
- Function and patient needs assessment - Goal Attainment Scores, Developmental Fine Motor Scale, Pediatric Evaluation and Disability Inventory (PEDI)
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improvement After Botulinum Toxin A Injections to the Upper Extremities in Children With Cerebral Palsy|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||September 2012|
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
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.
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.
CG children will undergo a program of intensive physiotherapy
- Quality of life [ Time Frame: 2 years ]
- 1. Hypertonia 2. Impairment measures 3. Upper extremity function 4. Function and patient needs assessment [ Time Frame: 2 years ]
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): NCT00549471
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 91031|
|Principal Investigator:||Hilla Ben-Pazi, MD||Shaare Zedek Medical Center|