Assessment of Gait After Dysport Treatment

Video and Temporal Spatial Parameters Assessment of Gait After Dysport Treatment. A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Equinovarus; Acquired
• Intervention / Treatment: Drug: Dysport

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States, 19002
      • MossRehab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: abobotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Selected Velocity (SSV)	Baseline and follow-up SSV with and without shoes. Distance covers over time at self selected pace. Larger value is better.	Baseline, Follow-up (4-6 weeks)
Maximal Velocity	Baseline and follow-up MV with and without shoes. Distance covers over time when walking as fast as possible. Larger value is better.	Baseline, Follow-up (4-6 weeks)
Step-length at Baseline and at Follow-up (Temporal-spatial Data)	Step length measured as the distance between the heel contact point of one foot and that of the other foot. Values are reported on the involved side. Larger values represent better outcome.	Baseline, Follow-up (4-6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale (MAS) at Baseline and at Follow-up	Passive range of ankle in 1 second with knee flexed and knee extended. Scale of 0-4 (0: no increase in muscle tone; 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+:Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2: More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3: Considerable increase in muscle tone passive, movement difficult; 4: Affected part(s) rigid in flexion or extension. 0-4 (Min-Max) Higher scores represents increase abnormal tone.	Baseline, Follow-up (4-6 weeks)
Tardieu Scale (TS) at Baseline and at Follow-up	Measurement of spastic response when passively ranging the ankle joint at very slow and very fast velocities with knee flexed and knee extended. Quality of muscle reaction (scored 0-4). 0 is no resistance to passive ROM to 4 indicating joint is immobile.	Baseline, Follow-up (4-6 weeks)
Passive Range of Motion (PROM) at Baseline and at Follow-up	Normal ranges of ankle dorsiflexion 0 to 30 degrees with knee flexed. Normal ranges of dorsiflexion 0 to 15 degrees with knee extended. Higher values in dorsiflexion range represent a better outcome.	Baseline, Follow-up (4-6 weeks)

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network
• Investigators: Principal Investigator: Alberto Esquenazi, MD, MossRehab

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Actual): August 22, 2019
• Study Completion (Actual): August 22, 2019

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Clubfoot; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; abobotulinumtoxinA
• Other Study ID Numbers: 5075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes