The effect of botulinum toxin-A on the functional ability of the very young child with spastic hemiplegia due to cerebral palsy.

Phase 3

Active, not recruiting

• Conditions: Neurological - Other neurological disorders; spasticity in children with cerebral palsy

• Registration Number: ACTRN12607000484448
• Lead Sponsor: Sarah Love

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

spastic hemiplegia due to CP

Exclusion Criteria

already independently ambulating;
concurrent unrelated disability or serious long term illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
quality of gait measured by Physicians Rating Scale (PRS), Toddler and Infant Motor Evaluation (TIME) and Gross Motor Performance Measure (GMPM)[3 monthly from time of independent walking until three years of age];amount of dynamic calf muscle spasticity measured by Modified Tardieu Scale(MTS) and Modifie4d Ashworth Score (MAS)[at 0, 1, 3, 6, 7, 9, 12, 13, 15, 18, 19, 21, 24, 25, 17, 30, 31 months];gross motor function as measured by the Gross Motor Function Measure (GMFM), and the Toddler and Infant Motor Evaluation (TIME)[0, 6, 12, 18, 24 months after motor stage of pull to stand]

Secondary Outcome Measures

Name	Time	Method
upper limb function measured by Assisting Hand Assessment (AHA)[at 3 years of age]