Back to resultsBotulinum Toxin A & Weekly Serial Casting in ABI Inpatients With Lower Extremity Spasticity (ChemoCast)
Primary Purpose
Spastic Foot
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Botulinum toxin type A
Serial Casting
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Foot
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Chemodenervation + Serial Casting
Chemodenervation without serial casting
Arm 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)
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.
Outcomes
Primary Outcome Measures
Passive ankle dorsiflexion >10 degrees
we are measuring passive ankle range of motion with respect to dorsiflexion greater than 10 degrees
Secondary Outcome Measures
Full Information
NCT ID
NCT03903653
First Posted
December 2, 2018
Last Updated
September 26, 2023
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03903653
Brief Title
Botulinum Toxin A & Weekly Serial Casting in ABI Inpatients With Lower Extremity Spasticity
Acronym
ChemoCast
Official Title
Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and Without Serial Casting in Lower Limb Spasticity Following ABI
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
unable to enroll patients due to closure of our inpatient units secondary to COVID-19.
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemodenervation + Serial Casting
Arm Type
Active Comparator
Arm 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)
Arm Title
Chemodenervation without serial casting
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Botox
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Serial Casting
Other Intervention Name(s)
Casting
Intervention Description
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)
Primary Outcome Measure Information:
Title
Passive ankle dorsiflexion >10 degrees
Description
we are measuring passive ankle range of motion with respect to dorsiflexion greater than 10 degrees
Time Frame
4-6 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyed Hossein Hosseini, M.D.
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Botulinum Toxin A & Weekly Serial Casting in ABI Inpatients With Lower Extremity Spasticity
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