Botulinum Toxin A & Weekly Serial Casting in ABI Inpatients With Lower Extremity Spasticity
NCT ID: NCT03903653
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2019-09-01
2019-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Chemodenervation + 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)
Botulinum toxin type A
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)
Serial Casting
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)
Chemodenervation without serial casting
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.
Botulinum toxin type A
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)
Interventions
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Botulinum toxin type A
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)
Serial Casting
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
No
Sponsors
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Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Ali Fateh
Resident - Dept of Physical Medicine and Rehabilitation
Principal Investigators
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Seyed Hossein Hosseini, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation
Other Identifiers
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5301
Identifier Type: -
Identifier Source: org_study_id
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