Clinical trial NCT03501043: Assessment of Gait After Dysport Treatment
Official title: Video and Temporal Spatial Parameters Assessment of Gait After Dysport Treatment. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Equinovarus; Acquired
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self-Selected Velocity (SSV)
timeFrame: Baseline, Follow-up (4-6 weeks)
measure: Maximal Velocity
timeFrame: Baseline, Follow-up (4-6 weeks)
measure: Step-length at Baseline and at Follow-up (Temporal-spatial Data)
timeFrame: Baseline, Follow-up (4-6 weeks)
Secondary outcomes:
measure: Modified Ashworth Scale (MAS) at Baseline and at Follow-up
timeFrame: Baseline, Follow-up (4-6 weeks)
measure: Tardieu Scale (TS) at Baseline and at Follow-up
timeFrame: Baseline, Follow-up (4-6 weeks)
measure: Passive Range of Motion (PROM) at Baseline and at Follow-up
timeFrame: Baseline, Follow-up (4-6 weeks)
Other outcomes:
Locations:
city: Elkins Park
country: United States
facility: MossRehab
state: Pennsylvania
Study officials:
affiliation: MossRehab
name: Alberto Esquenazi, MD
role: PRINCIPAL_INVESTIGATOR
References: