Botulinum Toxin A & Weekly Serial Casting in ABI Inpatients With Lower Extremity Spasticity (NCT03903653) | Clinical Trial Compass
WithdrawnPhase 2
Botulinum Toxin A & Weekly Serial Casting in ABI Inpatients With Lower Extremity Spasticity
Stopped: unable to enroll patients due to closure of our inpatient units secondary to COVID-19.
0Started 2019-09-01
Plain-language summary
Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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