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出境医 / 临床实验 / Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia (GAIT-TOX)

Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia (GAIT-TOX)

Study Description
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


Condition or disease Intervention/treatment Phase
Cervical Dystonia, Primary Blepharospasm Other: Treadmill Drug: Botulinum Toxin injection Diagnostic Test: Severity scale of the disease Not Applicable

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Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Analyse de la Marche de Patients Atteints de Dystonie Focale Avant et après Traitement Par Toxine Botulique
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : June 2, 2021
Estimated Study Completion Date : December 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Cervical Dystonia (CD)
Patients with cervical dystonia
Other: Treadmill
Walk on the Biodex Gait Trainer (TM) 3 Treadmill for registration of gait parameters Gait parameters will be evaluated 5 weeks after Botulinum Toxin injection for the two experimental groups and 5 weeks after the first evaluation for the control groups

Drug: Botulinum Toxin injection
injection of Botulinum Toxin in the two groups of CD and BS
Other Name: Injection

Diagnostic Test: Severity scale of the disease
JRS for BS TWSTRS for CD
Other Name: Scale

Placebo Comparator: Healthy Control CD
CD age- and sex-matched healthy control subjects
Other: Treadmill
Walk on the Biodex Gait Trainer (TM) 3 Treadmill for registration of gait parameters Gait parameters will be evaluated 5 weeks after Botulinum Toxin injection for the two experimental groups and 5 weeks after the first evaluation for the control groups

Experimental: Blepharospasm (BS)
Patients with blepharospasm
Other: Treadmill
Walk on the Biodex Gait Trainer (TM) 3 Treadmill for registration of gait parameters Gait parameters will be evaluated 5 weeks after Botulinum Toxin injection for the two experimental groups and 5 weeks after the first evaluation for the control groups

Drug: Botulinum Toxin injection
injection of Botulinum Toxin in the two groups of CD and BS
Other Name: Injection

Diagnostic Test: Severity scale of the disease
JRS for BS TWSTRS for CD
Other Name: Scale

Placebo Comparator: Healthy Control BS
BS age- and sex-matched healthy control subjects
Other: Treadmill
Walk on the Biodex Gait Trainer (TM) 3 Treadmill for registration of gait parameters Gait parameters will be evaluated 5 weeks after Botulinum Toxin injection for the two experimental groups and 5 weeks after the first evaluation for the control groups

Outcome Measures
Primary Outcome Measures :
  1. gait velocity [ Time Frame: 5 minutes ]
    comfortable gait velocity on the treadmill


Secondary Outcome Measures :
  1. step frequency [ Time Frame: 5 minutes ]
    registration on the treadmill

  2. step length [ Time Frame: 5 minutes ]
    registration on the treadmill

  3. step length asymmetry [ Time Frame: 5 minutes ]
    registration on the treadmill

  4. shortest step side [ Time Frame: 5 minutes ]
    registration on the treadmill

  5. step length variability [ Time Frame: 5 minutes ]
    registration on the treadmill


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
France
CHU Grenoble Alpes Recruiting
La Tronche, Isere, France, 38700
Contact: Justine CUINAT, MSc    +33 (0)4 76 76 35 28    jcuinat@chu-grenoble.fr   
Principal Investigator: Elena MORO, PhD         
Sub-Investigator: Valérie FRAIX, PhD         
Sub-Investigator: Anna CASTRIOTO, PhD         
Sub-Investigator: Sara MEONI, PhD         
Sub-Investigator: Justine CUINAT, MSc         
Sponsors and Collaborators
University Hospital, Grenoble
Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date March 29, 2021
Actual Study Start Date  ICMJE October 23, 2019
Estimated Primary Completion Date June 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
gait velocity [ Time Frame: 5 minutes ]
comfortable gait velocity on the treadmill
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • step frequency [ Time Frame: 5 minutes ]
    registration on the treadmill
  • step length [ Time Frame: 5 minutes ]
    registration on the treadmill
  • step length asymmetry [ Time Frame: 5 minutes ]
    registration on the treadmill
  • shortest step side [ Time Frame: 5 minutes ]
    registration on the treadmill
  • step length variability [ Time Frame: 5 minutes ]
    registration on the treadmill
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • step frequency [ Time Frame: 5 minutes ]
    registration on the treadmill
  • step length [ Time Frame: 5 minutes ]
    registration on the treadmill
  • step length assymetry [ Time Frame: 5 minutes ]
    registration on the treadmill
  • shortest step side [ Time Frame: 5 minutes ]
    registration on the treadmill
  • step length variability [ Time Frame: 5 minutes ]
    registration on the treadmill
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Cervical Dystonia, Primary
  • Blepharospasm
Intervention  ICMJE
  • Other: Treadmill
    Walk on the Biodex Gait Trainer (TM) 3 Treadmill for registration of gait parameters Gait parameters will be evaluated 5 weeks after Botulinum Toxin injection for the two experimental groups and 5 weeks after the first evaluation for the control groups
  • Drug: Botulinum Toxin injection
    injection of Botulinum Toxin in the two groups of CD and BS
    Other Name: Injection
  • Diagnostic Test: Severity scale of the disease
    JRS for BS TWSTRS for CD
    Other Name: Scale
Study Arms  ICMJE
  • Experimental: Cervical Dystonia (CD)
    Patients with cervical dystonia
    Interventions:
    • Other: Treadmill
    • Drug: Botulinum Toxin injection
    • Diagnostic Test: Severity scale of the disease
  • Placebo Comparator: Healthy Control CD
    CD age- and sex-matched healthy control subjects
    Intervention: Other: Treadmill
  • Experimental: Blepharospasm (BS)
    Patients with blepharospasm
    Interventions:
    • Other: Treadmill
    • Drug: Botulinum Toxin injection
    • Diagnostic Test: Severity scale of the disease
  • Placebo Comparator: Healthy Control BS
    BS age- and sex-matched healthy control subjects
    Intervention: Other: Treadmill
Publications *
  • Tarsy D, Simon DK. Dystonia. N Engl J Med. 2006 Aug 24;355(8):818-29. Review.
  • Barr C, Barnard R, Edwards L, Lennon S, Bradnam L. Impairments of balance, stepping reactions and gait in people with cervical dystonia. Gait Posture. 2017 Jun;55:55-61. doi: 10.1016/j.gaitpost.2017.04.004. Epub 2017 Apr 4.
  • Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date June 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03938363
Other Study ID Numbers  ICMJE 38RC18.107
2019-A00502-55 ( Other Identifier: ID RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Grenoble
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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