Skip to main content
OpenTrials
Completed

NCT Number: NCT00432055

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sunnaas Rehabilitation Hospital

Bjoernemyr, Nesoddtangen, 1450, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Botulinum toxin type A (Botox)

Drug

Placebo (saline)

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sunnaas Rehabilitation Hospital

Other

Collaborators

  • The Royal Norwegian Ministry of Health

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2007
Registry last updated
Feb 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.