Assessment of Gait After Dysport Treatment

NCT ID: NCT03501043

Last Updated: 2020-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2019-08-22

Brief Summary

This pilot study will aim to understand the potential benefit of the assessment of walking using video slow motion for muscle selection and the development of an image catalogue guide of the potential results of injection of abobotulinumtoxinA by comparing foot postures before and after injection. The objective is to evaluate the use of video assessment to improve muscle selection for the injection of botulinum toxin A to improve walking outcomes. Primary outcomes include: self-selected velocity (SSV), maximal velocity (MV) and symmetry of walking. Secondary outcomes include: passive range of motion (PROM), Modified Ashworth Scale (MAS) and the Tardieu Scale (TS). Fifteen persons post stroke or TBI over age 18 with equinovarus foot deformity who are able to ambulate will be included in the study. Dysport 1000 to 1500 units will be used to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), tibialis posterior and long toe flexors. The duration of subjects' participation is 4-6 weeks.

Detailed Description

This is a prospective, single arm, non-randomized clinical study with pre-post assessment to include post-stroke and Traumatic Brain Injury (TBI) outpatients with spastic ankle / foot muscles amenable to botulinum toxin injection. Subjects must be able to walk without braces.

AbobotulinumtoxinA injection in a dose range of 500 to 1500 units one time to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors, knee flexors, tibialis posterior and long toe flexors.

Conditions

Equinovarus; Acquired

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dysport

Subjects will receive 1000 to 1500 units of Dysport to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors and flexors, tibialis posterior and long toe flexors for one injection.

Group Type: EXPERIMENTAL

Dysport

Intervention Type: DRUG

Dysport 1000 to 1500 units to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors and flexors, tibialis posterior and long toe flexors.

Interventions

Dysport

Dysport 1000 to 1500 units to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors and flexors, tibialis posterior and long toe flexors.

Intervention Type: DRUG

Other Intervention Names

abobotulinumtoxinA

Eligibility Criteria

Inclusion Criteria

• Provide signed and dated informed consent form
• Willing to comply with all study procedures and be available for the duration of the study
• Male or female, aged ≥ 18
• Equinovarus foot deformity appropriate for botulinum toxin treatment (naïve or non-naïve)
• Modified Ashworth Scale between 1 to 3
• Women of reproductive potential must use effective contraception for the duration of the study

Exclusion Criteria

• Inability to walk without leg brace
• Previous surgical intervention to affected/ankle/foot
• Uncontrolled seizures
• Pregnancy or lactation
• Known allergic reactions to Dysport
• Treatment with another investigational drug or other intervention in the past 4 months
• Modified Ashworth Scale 4
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
• Lower motor neuron disorder
• < Four months post botulinum toxin or serial casting

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Alberto Esquenazi

Chairman of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Esquenazi, MD

Role: PRINCIPAL_INVESTIGATOR

MossRehab

Locations

MossRehab

Elkins Park, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5075

Identifier Type: -

Identifier Source: org_study_id