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

Sponsor
Hamilton Health Sciences Corporation (Other)
Overall Status
Unknown status
CT.gov ID
NCT03903653
Collaborator
(none)
20
Enrollment
2
Arms
3
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Botox

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Passive ankle dorsiflexion >10 degrees [4-6 weeks]

      we are measuring passive ankle range of motion with respect to dorsiflexion greater than 10 degrees

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hamilton Health Sciences Corporation

    Investigators

    • Principal Investigator: Seyed Hossein Hosseini, M.D., Hamilton Health Sciences Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Apr 4, 2019
    Last Update Posted:
    Apr 4, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Muscle Spasticity
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Apr 4, 2019