The impact of Botox on muscle structure and function in children with cerebral palsy

Not Applicable

Recruiting

• Conditions: Cerebral palsy; Neurological - Other neurological disorders; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12615001162505
• Lead Sponsor: Dr Lee Barber

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Confirmed diagnosis of unilateral or bilateral spastic type CP with a predominant spastic motor type and more involvement of the lower limb.
2. Aged 2-5 years at study entry.
3. Gross Motor Functional Classification System (GMFCS) classification of I-II, independently ambulant.
4. Maximum passive ankle dorsiflexion greater than or equal to -5 degrees (5 degrees plantarflexed).
5. Prescribed intramuscular BoNT-A injection to the lower leg for spasticity treatment
Sufficient co-operation and cognitive understanding to participate in the assessments.

Exclusion Criteria

Exclusion Criteria:
1. Predominant lower limb dystonia motor type
2. Previous lower limb intramuscular BoNT-A injections
3. Previous lower limb surgical interventions
4. Contraindications for BoNT/A injection treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified