Sunnaas Rehabilitation Hospital
Bjoernemyr, Nesoddtangen, 1450, Norway
NCT Number: NCT00432055
The purpose of this project is to investigate if there is a significant difference in active joint range of motion, questionnaire on gait function and health related quality of life between patients randomized to treatment with Botulinum toxin type A and patients randomized to placebo treatment.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Bjoernemyr, Nesoddtangen, 1450, Norway
Cerebral palsy (CP) is a constellation of symptoms and conditions defined as lifelong motor dysfunction resulting rom a non-progressive brain lesion occurring pre-, peri- or postnatal before the second year of life. CP consists of different aspect of motor disorder including spasticity, paresis, incoordination and dystonia
There is scarce knowledge about the association between spasticity, pain and physical function in the adult CP-population, and the systematic follow up of patients with CP typically ends at the age of eighteen. Frequently used intervention in spastic cerebral palsy for children with gait problems are injections with Botulinum toxin type A (Btx-A) in leg and thigh muscles, and three dimensional-gait analysis has become a standard procedure in treatment decision and evaluation.
Botulinum toxin A (Btx- A) is a highly effective treatment in the management of spasticity. The first reported success of use of Btx-A in children with cerebral palsy was made in 1993 by Koman et al. Subsequently, randomized controlled studies on children with spastic type of cerebral palsy has documented that Btx-A is effective and safe in the management of muscle spasticity in children with CP. There is an implicit, and as of yet, unproven assumption that there is no indication for this treatment in the adult CP-population.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 8 week
Time frame: 8 week , 16 week
Time frame: 8 week, 16 week
Time frame: 8 week, 16 week
Time frame: 8 week,
Time frame: 8 week
Time frame: 8 week, 16 week
Time frame: 8 week
Time frame: 8 week
Time frame: 0 week
Time frame: 8 week, 16 week
Time frame: 8 week, 16 week
Sunnaas Rehabilitation Hospital
Other
A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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