Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

February 23, 2009 updated by: Sunnaas Rehabilitation Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Nesoddtangen
      • Bjoernemyr, Nesoddtangen, Norway, 1450
        • Sunnaas rehabilitation hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: II
Drug: placebo (saline)
Experimental: I
Botox
Drug: Botulinum toxin type A (Botox)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnaas Rehabilitation Hospital

Collaborators

The Royal Norwegian Ministry of Health

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

February 5, 2007

First Submitted That Met QC Criteria

February 5, 2007

First Posted (Estimate)

February 6, 2007

Study Record Updates

Last Update Posted (Estimate)

February 24, 2009

Last Update Submitted That Met QC Criteria

February 23, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20624503
  • EudraCTnumber: 2006-001427-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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