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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
Sunnaas Rehabilitation Hospital
Bjoernemyr, Nesoddtangen, Norway
Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis)
Time frame: 8 week
Summary measure of health related quality of life (SF-36)
Time frame: 8 week , 16 week
Stiffness/spasticity according to VAS
Time frame: 8 week, 16 week
Questionnaire gait function
Time frame: 8 week, 16 week
Spasticity in ankle, knee and hip according to Modified Ashworth Scale
Time frame: 8 week,
3D-gait data (Kinetics,Temporospatial (stride length, velocity)
Time frame: 8 week
Global Scale
Time frame: 8 week, 16 week
Timed Up and Go
Time frame: 8 week
6 minutes walking test
Time frame: 8 week
Registrations of sample characteristics
Time frame: 0 week
Registration of adverse reactions
Time frame: 8 week, 16 week
Pain according to VAS
Time frame: 8 week, 16 week
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