Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia (GAIT-TOX)
Primary Purpose
Cervical Dystonia, Primary, Blepharospasm
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Treadmill
Botulinum Toxin injection
Severity scale of the disease
Sponsored by
About this trial
This is an interventional basic science trial for Cervical Dystonia, Primary focused on measuring cervical dystonia, blepharospasm, gait parameters, botulinum toxin
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
Sites / Locations
- CHU Grenoble Alpes
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Cervical Dystonia (CD)
Healthy Control CD
Blepharospasm (BS)
Healthy Control BS
Arm Description
Patients with cervical dystonia
CD age- and sex-matched healthy control subjects
Patients with blepharospasm
BS age- and sex-matched healthy control subjects
Outcomes
Primary Outcome Measures
gait velocity
comfortable gait velocity on the treadmill
Secondary Outcome Measures
step frequency
registration on the treadmill
step length
registration on the treadmill
step length asymmetry
registration on the treadmill
shortest step side
registration on the treadmill
step length variability
registration on the treadmill
Full Information
NCT ID
NCT03938363
First Posted
May 2, 2019
Last Updated
January 6, 2023
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT03938363
Brief Title
Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia
Acronym
GAIT-TOX
Official Title
Analyse de la Marche de Patients Atteints de Dystonie Focale Avant et après Traitement Par Toxine Botulique
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia, Primary, Blepharospasm
Keywords
cervical dystonia, blepharospasm, gait parameters, botulinum toxin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervical Dystonia (CD)
Arm Type
Experimental
Arm Description
Patients with cervical dystonia
Arm Title
Healthy Control CD
Arm Type
Placebo Comparator
Arm Description
CD age- and sex-matched healthy control subjects
Arm Title
Blepharospasm (BS)
Arm Type
Experimental
Arm Description
Patients with blepharospasm
Arm Title
Healthy Control BS
Arm Type
Placebo Comparator
Arm Description
BS age- and sex-matched healthy control subjects
Intervention Type
Other
Intervention Name(s)
Treadmill
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin injection
Other Intervention Name(s)
Injection
Intervention Description
injection of Botulinum Toxin in the two groups of CD and BS
Intervention Type
Diagnostic Test
Intervention Name(s)
Severity scale of the disease
Other Intervention Name(s)
Scale
Intervention Description
JRS for BS TWSTRS for CD
Primary Outcome Measure Information:
Title
gait velocity
Description
comfortable gait velocity on the treadmill
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
step frequency
Description
registration on the treadmill
Time Frame
5 minutes
Title
step length
Description
registration on the treadmill
Time Frame
5 minutes
Title
step length asymmetry
Description
registration on the treadmill
Time Frame
5 minutes
Title
shortest step side
Description
registration on the treadmill
Time Frame
5 minutes
Title
step length variability
Description
registration on the treadmill
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
CHU Grenoble Alpes
City
La Tronche
State/Province
Isere
ZIP/Postal Code
38700
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
16928997
Citation
Tarsy D, Simon DK. Dystonia. N Engl J Med. 2006 Aug 24;355(8):818-29. doi: 10.1056/NEJMra055549. No abstract available.
Results Reference
background
PubMed Identifier
28412603
Citation
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.
Results Reference
background
PubMed Identifier
23649720
Citation
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.
Results Reference
background
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Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia
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