Assessment of Gait After Dysport Treatment

NCT03501043 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 5075
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Equinovarus; Acquired

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Modified Ashworth Scale (MAS) at Baseline and at Follow-up

  Baseline, Follow-up (4-6 weeks)

• Tardieu Scale (TS) at Baseline and at Follow-up

  Baseline, Follow-up (4-6 weeks)

• Passive Range of Motion (PROM) at Baseline and at Follow-up

  Baseline, Follow-up (4-6 weeks)

Study Arms (1)

Dysport

EXPERIMENTAL

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

Interventions

Dysport 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.

Also known as: abobotulinumtoxinA

Dysport

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

MossRehab

Elkins Park, Pennsylvania, 19002, United States

Location

MeSH Terms

Conditions

Clubfoot

Interventions

abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Stella Lee
• Organization: MossRehab

leest@einstein.edu

215-663-6665

Study Officials

• Alberto Esquenazi, MD

  MossRehab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 18, 2018
• Study Start: June 11, 2018
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: March 2, 2020
• Results First Posted: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)