Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
  • Phase

    Phase 4
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    rimabotulinumtoxinB ...
  • Study Participants

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 Started
Jan 31
Primary Completion
Jan 31
Study Completion
Jan 31
Last Update
Feb 24

Drug Botulinum toxin type A (Botox)

Drug placebo (saline)

I Experimental


II Placebo Comparator


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)
No Results Posted