Cerebral Palsy
Conditions
Keywords
Adult, Cerebral Palsy, Spastic contractures, Botulinum toxin type A
Brief summary
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.
Detailed description
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.
Interventions
DRUGplacebo (saline)
Sponsors
The Royal Norwegian Ministry of Health
Sunnaas Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral or bilateral spastic CP * Modified Ashworth Scale (MAS) ≥ 2 in ankle- or knee joint muscles. * ≥ 18 year of age, ≤ 65 year of age * Ambulant without walking aids minimum 10 metres in functional equines and/or with pathological knee extension or flexion pattern.
Exclusion criteria
* Cognitive impairment. * No spasticity (MAS \< 2 ) * \< 18 year of age * Not ambulant without walking aids * Pregnant or planning pregnancy * Btx-A treatment last 6 months * Orthopedic surgery lower extremity last 18 months * Obvious skeletal/joint deformity where orthopedic surgery is indicated * Other diseases which can affect level of function (rheumatoid or neurological ) * New treatment the past four weeks which affect the musculoskeletal system (pain killers, physical therapy, acupuncture)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis) | 8 week |
| Summary measure of health related quality of life (SF-36) | 8 week , 16 week |
Secondary
| Measure | Time frame |
|---|---|
| Spasticity in ankle, knee and hip according to Modified Ashworth Scale | 8 week, |
| 3D-gait data (Kinetics,Temporospatial (stride length, velocity) | 8 week |
| Global Scale | 8 week, 16 week |
| Timed Up and Go | 8 week |
| Stiffness/spasticity according to VAS | 8 week, 16 week |
| Registrations of sample characteristics | 0 week |
| Registration of adverse reactions | 8 week, 16 week |
| Pain according to VAS | 8 week, 16 week |
| 6 minutes walking test | 8 week |
| Questionnaire gait function | 8 week, 16 week |
Countries
Norway
Outcome results
None listed