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

Hamilton Health Sciences (HHS)

Status and phase: Withdrawn; Phase 2

Conditions: Spastic Foot

Treatments: Device: Serial Casting; Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT03903653

5301

Details and patient eligibility

About

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

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Chemodenervation + Serial Casting

Active Comparator group

Description:

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)

Treatment:

Drug: Botulinum toxin type A

Device: Serial Casting

Chemodenervation without serial casting

Active Comparator group

Description:

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.

Treatment:

Drug: Botulinum toxin type A