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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion Criteria

• Patients with Acquired Brain Injury (ABI) including but not limited to stroke, traumatic and anoxic brain injury in ABI unit of RRC

• Dorsiflexion limitation of < 10 degrees from neutral and Modified Ashworth Score (MAS) of 2 or 3

• Patients that are on Oral Medication for Spasticity Tx are still allowed to participate (ie. Baclofen)

• Patients both with Bilateral or Unilateral Lower Limb Spasticity are included

• There will be no sex or age restrictions

Exclusion Criteria

• Patients cannot have had Botulinum Toxin A Injections in their Lower Extremities within the past 6 months

• Patients cannot have had any sort of custom bracing or serial casting previously

• Patients with MAS of 4

• Patients with generalized spasticity that require other alternative treatment such as intra-thecal baclofen or surgical intervention

• Patients need to be medically stable (all co-morbidities under control via medical/pharmacological therapy), patients with ongoing co-morbid medical condition that are unmanaged will be excluded.

• Patients whom have skin breakdown in their lower extremities prior to the study will be excluded

• Patients who develop Skin breakdown (Grade 2 or higher) during the course of the study will be removed automatically