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Assessment of Gait After Dysport Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03501043
Recruitment Status : Completed
First Posted : April 18, 2018
Results First Posted : March 2, 2020
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Alberto Esquenazi, Albert Einstein Healthcare Network

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.

Condition or disease Intervention/treatment Phase
Equinovarus; Acquired Drug: Dysport Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Video and Temporal Spatial Parameters Assessment of Gait After Dysport Treatment. A Pilot Study
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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 Name: abobotulinumtoxinA




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501043


Locations
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United States, Pennsylvania
MossRehab
Elkins Park, Pennsylvania, United States, 19002
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
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Principal Investigator: Alberto Esquenazi, MD MossRehab
  Study Documents (Full-Text)

Documents provided by Alberto Esquenazi, Albert Einstein Healthcare Network:
Informed Consent Form  [PDF] March 28, 2019

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Responsible Party: Alberto Esquenazi, Chairman of Physical Medicine and Rehabilitation, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT03501043    
Other Study ID Numbers: 5075
First Posted: April 18, 2018    Key Record Dates
Results First Posted: March 2, 2020
Last Update Posted: March 2, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Clubfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs