Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    Recruiting, Not yet recruiting, Available Studies | "Blepharospasm"

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03938363
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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

  Show Detailed Description

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
Estimated Study Start Date : June 3, 2019
Estimated Primary Completion Date : June 2, 2021
Estimated Study Completion Date : December 1, 2021


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




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



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.


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

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): NCT03938363


Locations
Layout table for location information
France
CHU Grenoble Alpes
La Tronche, Isere, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble

Publications:
Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03938363     History of Changes
Other Study ID Numbers: 38RC18.107
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
cervical dystonia
blepharospasm
gait parameters
botulinum toxin
Additional relevant MeSH terms:
Layout table for MeSH terms
Blepharospasm
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Eyelid Diseases
Eye Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs