Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnaas Rehabilitation Hospital
• Collaborator: The Royal Norwegian Ministry of Health
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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)