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

Spastic Foot Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03903653
• Other study ID #: 5301
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: September 2023
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spastic Foot

Intervention

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)

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Passive ankle dorsiflexion >10 degrees	we are measuring passive ankle range of motion with respect to dorsiflexion greater than 10 degrees	4-6 weeks