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

NCT03903653 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 5301
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spastic Foot

Outcome Measures

Primary Outcomes (1)

• Passive ankle dorsiflexion >10 degrees

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

  4-6 weeks

Study Arms (2)

Chemodenervation + Serial Casting

ACTIVE COMPARATOR

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; Device: Serial Casting

Chemodenervation without serial casting

ACTIVE COMPARATOR

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

Interventions

Botulinum toxin type A DRUG

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)

Also known as: Botox

Chemodenervation + Serial Casting; Chemodenervation without serial casting

Serial Casting DEVICE

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)

Also known as: Casting

Chemodenervation + Serial Casting

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Seyed Hossein Hosseini, M.D.

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident - Dept of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: April 4, 2019
• Study Start: September 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 28, 2023

Record last verified: 2023-09