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Completed

NCT Number: NCT03501043

Assessment of Gait After Dysport Treatment

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MossRehab

Elkins Park, Pennsylvania, 19002, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: abobotulinumtoxinA

Primary outcomes

  1. Self-Selected Velocity (SSV)

    Time frame: Baseline, Follow-up (4-6 weeks)

    Baseline and follow-up SSV with and without shoes. Distance covers over time at self selected pace. Larger value is better.

  2. Maximal Velocity

    Time frame: Baseline, Follow-up (4-6 weeks)

    Baseline and follow-up MV with and without shoes. Distance covers over time when walking as fast as possible. Larger value is better.

  3. Step-length at Baseline and at Follow-up (Temporal-spatial Data)

    Time frame: Baseline, Follow-up (4-6 weeks)

    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.

Secondary outcomes

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

    Time frame: Baseline, Follow-up (4-6 weeks)

    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.

  2. Tardieu Scale (TS) at Baseline and at Follow-up

    Time frame: Baseline, Follow-up (4-6 weeks)

    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.

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

    Time frame: Baseline, Follow-up (4-6 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Albert Einstein Healthcare Network

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2018
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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