Clinical trial NCT00432055: Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
Official title: A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebral Palsy
Keywords: Adult
Cerebral Palsy
Spastic contractures
Botulinum toxin type A
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
First posted: 2007-02-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis)
timeFrame: 8 week
measure: Summary measure of health related quality of life (SF-36)
timeFrame: 8 week , 16 week
Secondary outcomes:
measure: Stiffness/spasticity according to VAS
timeFrame: 8 week, 16 week
measure: Questionnaire gait function
timeFrame: 8 week, 16 week
measure: Spasticity in ankle, knee and hip according to Modified Ashworth Scale
timeFrame: 8 week,
measure: 3D-gait data (Kinetics,Temporospatial (stride length, velocity)
timeFrame: 8 week
measure: Global Scale
timeFrame: 8 week, 16 week
measure: Timed Up and Go
timeFrame: 8 week
measure: 6 minutes walking test
timeFrame: 8 week
measure: Registrations of sample characteristics
timeFrame: 0 week
measure: Registration of adverse reactions
timeFrame: 8 week, 16 week
measure: Pain according to VAS
timeFrame: 8 week, 16 week
Other outcomes:
Locations:
city: Bjoernemyr
country: Norway
facility: Sunnaas Rehabilitation Hospital
state: Nesoddtangen
Study officials:
affiliation: Research Departement, Sunnaas Rehabilitation Hospital
name: Johan K Stanghelle, Professor MD
role: STUDY_CHAIR
References: