Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

Condition(s) targeted: Cerebral Palsy

Intervention: Botulinum toxin type A (Botox) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sunnaas Rehabilitation Hospital

Official(s) and/or principal investigator(s):
Johan K Stanghelle, Professor MD, Study Chair, Affiliation: Research Departement, Sunnaas Rehabilitation Hospital

The purpose of this project is to investigate if there is a significant difference in active joint range of motion, questionnaire on gaitfunction and health related quality of life between patients randomized to treatment with Botulinum toxin type A and patients randomized to placebotreatment

Official title: A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Ankle sagittal kinematic with corresponding knee- and hip data(3D-gait analysis)

Summary measure of health related quality of life (SF-36)

Measured at baseline, 8 week and 16 week

Secondary outcome:

Pain according to VAS

Stiffenss/spasticity according to VAS

Questionnaire gait function

Spasticity in ankle, knee and hip according to Modified Ashworth Scale

3D-gait data (Kinetics,Temporospatial (stride length, velocity)

Global Scale

Timed Up and Go

6 minutes walking test

Registrations of sample characteristics

Registration of adverse reactions

Detailed description: Cerebral palsy (CP) is a constellation of symptoms and conditions defined as lielong motor dysfunction resulting rom a non-progressive brain lesion occuring 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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)

Sunnaas Rehabilitation Hospital, bjoernemyr, Nesoddtangen 1450, Norway; Recruiting
Grethe Maanum, Phd-stud, MD, Phone: 0047 66 96 90 00, Email: grethe.manum@sunnaas.no
Johan K Stanghelle, Professor MD, Phone: 0047 66 96 90 00, Email: postmottak@sunnaas.no
Grethe Maanum, Phd-stud, MD, Principal Investigator

Starting date: January 2007
Ending date: December 2008
Last updated: February 5, 2007