NCT03903653

Botulinum Toxin A & Weekly Serial Casting in ABI Inpatients With Lower Extremity Spasticity

Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and Without Serial Casting in Lower Limb Spasticity Following ABI

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.

Detailed description

The investigators will be studying the effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI. patients are randomly divided into two groups: group 1 will undergo botox injection with weekly serial casting group 2 will undergo botox injection with physiotherapy The primary outcome is the effects of the proposed treatment with respect to passive dorsiflexion.

Conditions

• Spastic Foot

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A	Use of chemodenervation (botulinum toxin A) for treatment of lower extremity spasticity in ABI inpatients with regards to ankle range of motion. (a total of 350-400 units of botulinum toxin A per treated limb)
DEVICE	Serial Casting	Using Serial Casting in conjunction with Botox injection for treatment of lower extremity spasticity in ABI inpatients with regards to ankle range of motion. (a total of 350-400 units of botulinum toxin A per treated limb)

Timeline

• Start date: 2019-09-01
• Primary completion: 2019-11-01
• Completion: 2019-12-01
• First posted: 2019-04-04
• Last updated: 2023-09-28

Regulatory

• FDA-regulated drug study