Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Drug: Botulinum toxin type A (Botox)
* Drug: placebo (saline)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult, Cerebral Palsy, Spastic contractures, Botulinum toxin type A