Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia

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Brief Title

Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia

Official Title

Analyse de la Marche de Patients Atteints de Dystonie Focale Avant et après Traitement Par Toxine Botulique

Brief Summary

      Efficient gait requires effective postural control, both static and dynamic. Hence, postural
      disorders may affect gait. Yet, very little is known about the specific effects of focal
      postural disorders such as cervical dystonia (CD) and blepharospasm (BS) on patients'
      mobility.

      The present research therefore aims at analyzing gait characteristics in patients presenting
      with these conditions in order to document possible gait alterations.

      In addition, the investigators will explore the effect of botulinum toxin treatment, which
      the most frequently used therapeutic option, on the patients' gait characteristics. Indeed,
      while the treatment improves both dystonia and pain, and therefore quality of life, its
      influence on gait is presently unknown. the investigators aim at filling this knowledge gap
    

Detailed Description

      This is a pilot monocentric, non-randomized, controlled study. The total duration of the
      project is 24 months. For each patient, the total duration of the study will be one month.

      The primary goal is to study gait parameters in patients with focal dystonia (CD and BS)
      before and after botulinum toxin treatment.

      The secondary goal is to study interactions between dystonia severity and gait disorders, if
      gait disorders are objectified. The investigators will also examine whether botulinum toxin
      treatment affects gait parameters.

      The main dependent variable regarding gait analysis will be gait velocity, as it is the most
      relevant functional variable for the patients. Gait velocity will be measured on the ground
      using the 10 Meter Walk Test (10MWT). Gait velocity will thereafter be adjusted to the
      treadmill to be the most comfortable. Spatial and temporal gait parameters will also be
      analyzed, namely: step frequency, step length, step length variability, gait asymmetry, and
      side with the shortest step length.

      To examine the influence of dystonia severity on gait parameters, the investigators will
      examine possible links between the gait parameters and dystonia severity as reflected by the
      global scores of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) for cervical
      dystonia and the Jankovic Rating Scale (JRS) for blepharospasm.

      In order to evaluate the effects of the botulinum toxin on gait parameters, the investigators
      will compare gait variables before and after toxin treatment in the patient groups. If gait
      parameters are influenced by the treatment, the investigators will compare the post treatment
      data with the data of the healthy control group. In addition, the investigators will perform
      a patient satisfaction scale (Patient Global Impression of Change) on the change of walking
      parameters.

      For this pilot, longitudinal, prospective, controlled study, the investigators will include
      two groups of 10 patients (patients with DC, patients with BS, naive or not about botulinum
      toxin treatment) and two groups of 10 age- and sex-matched healthy control subjects.

      After collecting demographical information, severity of dystonia will be assessed using the
      relevant Dystonia scale (for the patients' groups).

      Participants will then be shortly trained walking on a treadmill. Thereafter, they will be
      required to walk on a BIODEX treadmill enabling recording of all targeted gait parameters.
      For the patients' groups, gait parameters will be recorded both before and 4-5 weeks after
      the injection.

      At the firth visit, the duration of assessments and treatment for the patients will be about
      1.5 hour. At the second visit, assessment will last about 30 minutes.

      To examine the influence of dystonia (CD, BS) on gait velocity and parameters, patients and
      matched healthy control data will be compared using the Mann-Whitney non parametric test. To
      examine the influence of botulinum toxin injection in each group of patients, data will be
      compared using the Wilcoxon test. Pearson correlation will be used to examine possible links
      between dystonia severity and gait parameters alterations.

      This study will contribute to improving our knowledge on the effects of focal dystonia on
      gait, thus enabling an improvement in the design of rehabilitation programs. It will also
      document the effect of botulinum toxin on gait, thus contributing to a better guidance of
      this treatment.
    


Study Type

Interventional


Primary Outcome

gait velocity

Secondary Outcome

 step frequency

Condition

Cervical Dystonia, Primary

Intervention

Treadmill

Study Arms / Comparison Groups

 Cervical Dystonia (CD)
Description:  Patients with cervical dystonia

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

40

Start Date

October 23, 2019

Completion Date

December 1, 2021

Primary Completion Date

June 2, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  speaking French, in the ability to understand clinical tests and explorations,

          -  in ability to move to the CHU Grenoble Alpes

          -  Diagnosis of cervical dystonia or isolated Blepharospasm,

          -  Absence of neurological or psychiatric disorders,

          -  Affiliation to a health insurance,

          -  Signed consent fo the subject.

        Exclusion Criteria:

          -  Pregnant women (positive pregnancy test), parturient or breastfeeding

          -  Cervical dystonia or Blepharospasm of secondary origin

          -  subjects having benefited from deep brain stimulation,

          -  History of other pathologies that may lead to walking disorders, inability to walk
             without technical assistance, inability to walk for more than 10 minutes,

          -  Subjects receiving botulinum toxin treatment for another cause.

        Prohibited treatments and procedures:

          -  Antecedent of pathologies that may cause walking disorders

          -  Simultaneous participation in another Interventional study

          -  Subject in time of exclusion from another study

          -  Subject under guardianship or having curators (major protected)

          -  Subject under administrative or judicial supervision

          -  Subject not able to be contacted in case of emergency
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03938363

Organization ID

38RC18.107


Responsible Party

Sponsor

Study Sponsor

University Hospital, Grenoble


Study Sponsor

, , 


Verification Date

March 2020