Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

Sunnaas Rehabilitation Hospital

Status and phase

Completed

Phase 4

Conditions

Cerebral Palsy

Treatments

Drug: placebo (saline)

Drug: Botulinum toxin type A (Botox)

Study type

Interventional

Funder types

Other

Identifiers

NCT00432055

20624503

EudraCTnumber: 2006-001427-19

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)