Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

• ClinicalTrials.gov Identifier: NCT00432055
• Recruitment Status: Completed
• First Posted: February 6, 2007
• Last Update Posted: February 24, 2009
• Sponsor: Sunnaas Rehabilitation Hospital
• Collaborator: The Royal Norwegian Ministry of Health
• Information provided by: Sunnaas Rehabilitation Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy	Drug: Botulinum toxin type A (Botox); Drug: placebo (saline)	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
• Study Start Date: January 2007
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: I; Botox	Drug: Botulinum toxin type A (Botox)
Placebo Comparator: II	Drug: placebo (saline)

Outcome Measures

Primary Outcome Measures :

1. Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis) [ Time Frame: 8 week ]
2. Summary measure of health related quality of life (SF-36) [ Time Frame: 8 week , 16 week ]

Secondary Outcome Measures :

1. Stiffness/spasticity according to VAS [ Time Frame: 8 week, 16 week ]
2. Questionnaire gait function [ Time Frame: 8 week, 16 week ]
3. Spasticity in ankle, knee and hip according to Modified Ashworth Scale [ Time Frame: 8 week, ]
4. 3D-gait data (Kinetics,Temporospatial (stride length, velocity) [ Time Frame: 8 week ]
5. Global Scale [ Time Frame: 8 week, 16 week ]
6. Timed Up and Go [ Time Frame: 8 week ]
7. 6 minutes walking test [ Time Frame: 8 week ]
8. Registrations of sample characteristics [ Time Frame: 0 week ]
9. Registration of adverse reactions [ Time Frame: 8 week, 16 week ]
10. Pain according to VAS [ Time Frame: 8 week, 16 week ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

Norway

Sunnaas Rehabilitation Hospital

Bjoernemyr, Nesoddtangen, Norway, 1450

Sponsors and Collaborators

Sunnaas Rehabilitation Hospital

The Royal Norwegian Ministry of Health

Investigators

• Study Chair: Johan K Stanghelle, Professor MD; Research Departement, Sunnaas Rehabilitation Hospital

More Information

• Responsible Party: Johan K Stanghelle, Sunnaas Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT00432055
• Other Study ID Numbers: 20624503; EudraCTnumber: 2006-001427-19
• First Posted: February 6, 2007
• Last Update Posted: February 24, 2009
• Last Verified: February 2009

Keywords provided by Sunnaas Rehabilitation Hospital:

Adult; Cerebral Palsy; Spastic contractures; Botulinum toxin type A

Additional relevant MeSH terms:

Paralysis; Cerebral Palsy; Neurologic Manifestations; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents