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

Phase 2

Withdrawn

• Conditions: Spastic Foot
• Interventions: Drug: Botulinum toxin type A; Device: Serial Casting

• Registration Number: NCT03903653
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief 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.

Study Timeline

• Study First Submitted: 2018-12-02
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-04
• Study Start: 2019-09-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemodenervation + Serial Casting	Serial Casting	in this group a total of 10 patients will undergo Botulinum Toxin A injection and weekly serial casting Intervention = Weekly Serial Casting AND Botulinum Toxin A injection (350-400 units per treated limb)
Chemodenervation + Serial Casting	Botulinum toxin type A	in this group a total of 10 patients will undergo Botulinum Toxin A injection and weekly serial casting Intervention = Weekly Serial Casting AND Botulinum Toxin A injection (350-400 units per treated limb)
Chemodenervation without serial casting	Botulinum toxin type A	in this group a total of 10 patients will undergo Botulinum Toxin A injection. Intervention = Botulinum Toxin A injection (350-400 units per treated limb) alone.

Primary Outcome Measures

Name	Time	Method
Passive ankle dorsiflexion >10 degrees	4-6 weeks	we are measuring passive ankle range of motion with respect to dorsiflexion greater than 10 degrees