Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

This study has been completed.
Sponsor:
Collaborator:
The Royal Norwegian Ministry of Health
Information provided by:
Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT00432055
First received: February 5, 2007
Last updated: February 23, 2009
Last verified: February 2009
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:National Committee for Medical and Health Research Ethics
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
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014