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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCTnumber: 2006-001427-19 |
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| Name | Class |
|---|---|
| The Royal Norwegian Ministry of Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Botox |
|
| II | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A (Botox) | Drug |
| ||
| placebo (saline) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan K Stanghelle, Professor MD | Research Departement, Sunnaas Rehabilitation Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnaas Rehabilitation Hospital | Bjoernemyr | Nesoddtangen | 1450 | Norway |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| 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 |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |