Assessment of Gait After Dysport Treatment

A

Albert Einstein Healthcare Network

Status and phase

Completed
Phase 4

Conditions

Equinovarus; Acquired

Treatments

Drug: Dysport

Study type

Interventional

Funder types

Other

Identifiers

NCT03501043
5075

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

Dysport
Experimental group
Description:
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.
Treatment:
Drug: Dysport

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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