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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spastic Foot

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Device: Serial Casting


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chemodenervation + Serial Casting<br>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) | Drug: Botulinum toxin type A<br>* 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)<br>* Other names: Botox;Device: Serial Casting<br>* 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)<br>* Other names: Casting;|
| Active Comparator: Chemodenervation without serial casting<br>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. | Drug: Botulinum toxin type A<br>* 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)<br>* Other names: Botox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Passive ankle dorsiflexion >10 degrees | we are measuring passive ankle range of motion with respect to dorsiflexion greater than 10 degrees | 4-6 weeks |