Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy - Full Text View

Sponsor:	Sunnaas Rehabilitation Hospital
Collaborator:	The Royal Norwegian Ministry of Health
Information provided by:	Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier:	NCT00432055

Purpose

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	Intervention	Phase
Cerebral Palsy	Drug: Botulinum toxin type A (Botox) Drug: placebo (saline)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

Resource links provided by NLM:

MedlinePlus related topics: Botox Cerebral Palsy Paralysis Rehabilitation

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Sunnaas Rehabilitation Hospital:

Primary Outcome Measures:

Ankle sagittal kinematic with corresponding knee and hip data (3D-gait analysis) [ Time Frame: 8 week ] [ Designated as safety issue: No ]
Summary measure of health related quality of life (SF-36) [ Time Frame: 8 week , 16 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stiffness/spasticity according to VAS [ Time Frame: 8 week, 16 week ] [ Designated as safety issue: No ]
Questionnaire gait function [ Time Frame: 8 week, 16 week ] [ Designated as safety issue: No ]
Spasticity in ankle, knee and hip according to Modified Ashworth Scale [ Time Frame: 8 week, ] [ Designated as safety issue: No ]
3D-gait data (Kinetics,Temporospatial (stride length, velocity) [ Time Frame: 8 week ] [ Designated as safety issue: No ]
Global Scale [ Time Frame: 8 week, 16 week ] [ Designated as safety issue: No ]
Timed Up and Go [ Time Frame: 8 week ] [ Designated as safety issue: No ]
6 minutes walking test [ Time Frame: 8 week ] [ Designated as safety issue: No ]
Registrations of sample characteristics [ Time Frame: 0 week ] [ Designated as safety issue: No ]
Registration of adverse reactions [ Time Frame: 8 week, 16 week ] [ Designated as safety issue: No ]
Pain according to VAS [ Time Frame: 8 week, 16 week ] [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	January 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: I Botox	Drug: Botulinum toxin type A (Botox)
Placebo Comparator: II	Drug: placebo (saline)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432055

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

No publications provided

Responsible Party:	Johan K Stanghelle, Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier:	NCT00432055 History of Changes
Other Study ID Numbers:	20624503, EudraCTnumber: 2006-001427-19
Study First Received:	February 5, 2007
Last Updated:	February 23, 2009
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services

Keywords provided by Sunnaas Rehabilitation Hospital:

Adult
Cerebral Palsy
Spastic contractures
Botulinum toxin type A

Additional relevant MeSH terms:

Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A

Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012