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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903653
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ali Fateh, Hamilton Health Sciences Corporation

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.

Condition or disease Intervention/treatment Phase
Spastic Foot Drug: Botulinum toxin type A Device: Serial Casting Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Active Comparator: 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)
Drug: 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)

Other Name: Botox

Device: 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 Name: Casting

Active Comparator: 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.
Drug: 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)

Other Name: Botox




Primary Outcome Measures :
  1. Passive ankle dorsiflexion >10 degrees [ Time Frame: 4-6 weeks ]
    we are measuring passive ankle range of motion with respect to dorsiflexion greater than 10 degrees



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903653


Contacts
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Contact: Ali Fateh, M.D. 9055212100 ext 6217 alifatehmed@gmail.com

Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Seyed Hossein Hosseini, M.D. Hamilton Health Sciences Corporation
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Responsible Party: Ali Fateh, Resident - Dept of Physical Medicine and Rehabilitation, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT03903653    
Other Study ID Numbers: 5301
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents