NCT00432055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 24, 2009

Status Verified

February 1, 2009

Enrollment Period

2 years

First QC Date

February 5, 2007

Last Update Submit

February 23, 2009

Conditions

Cerebral Palsy

Keywords

AdultCerebral PalsySpastic contracturesBotulinum toxin type A

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

I

EXPERIMENTAL

Botox

Drug: Botulinum toxin type A (Botox)

II

PLACEBO COMPARATOR
Drug: placebo (saline)

Interventions

Botulinum toxin type A (Botox)DRUG
I
placebo (saline)DRUG
II

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnaas Rehabilitation Hospital

Bjoernemyr, Nesoddtangen, 1450, Norway

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type ASodium Chloride

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Johan K Stanghelle, Professor MD

    Research Departement, Sunnaas Rehabilitation Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2007

First Posted

February 6, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 24, 2009

Record last verified: 2009-02

Locations

NO(1)