A randomised controlled trial to determine the optimum frequency of Botulinum Toxin injections to the calf in children with cerebral palsy
Phase 3
Completed
- Conditions
- Cerebral palsy in childrenNeurological - Other neurological disorders
- Registration Number
- ACTRN12607000326493
- Lead Sponsor
- The Royal Children's Hospital, Melbourne, Victoria
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Level I, II, or III on the Gross Motor Function Classification System for cerebral palsyGastrocnemius muscle length greater than 5 degrees with the knee extendedGastrocnemius spasticity (no heel contact during the stance phase of gait)
Exclusion Criteria
Previous Botulinum Toxin A injections to the calf musclePrevious calf surgeryContraindications to the use of Botulinum Toxin A such as known hypersensitivity to any ingredient in the formulation, presence of Myasthenia Gravis or Eaton Lambert syndrome, or the presence of infection at the proposed injection site(s).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Passive length of gastrocnemius in degrees of dorsiflexion[At 0, 12 and 26 months]
- Secondary Outcome Measures
Name Time Method evel of Function measured using the Functional Mobility Scale <br>[0, 12, 26 months];Quality of Life measured using the Child Health Questionnaire<br>[0, 12, 26 months];Secondary Unresponsiveness to Botulinum Toxin A measured in two ways:<br>Assessing for the presence of neutralising antibodies to Botulinum Toxin A <br>[Blood collected prior to botulinum Toxin injections and assessed every 6 months.];Assessing the amount of dynamic gastrocnemius shortness measured by gait analysis<br>[Pre/post final injection at 26 and 27 months];3D ultrasound of medial gastrocnemius to determine muscle volumes[0, 12 and 26 months]