Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

Sponsor

Sunnaas Rehabilitation Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00432055

Collaborator

The Royal Norwegian Ministry of Health (Other)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jan 1, 2007

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: I

Botox

Drug: Botulinum toxin type A (Botox)

Placebo Comparator: II

Drug: placebo (saline)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)