Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03938363 Recruiting May 6, 2019 March 29, 2021

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: Blepharospasm
Cervical Dystonia, Primary
Intervention/treatment: Other: Treadmill
Drug: Botulinum Toxin injection
Diagnostic Test: Severity scale of the disease
Phase: N/A
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 design
Study Type: Interventional
Estimated Enrollment : 40 participants
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 apr├Ęs Traitement Par Toxine Botulique
Actual Study Start Date: October 2019
Estimated Primary Completion Date: June 2021
Estimated Study Completion Date: December 2021

Arms and interventions
Arm Intervention/treatment
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

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

Diagnostic Test: Severity scale of the disease
JRS for BS TWSTRS for CD
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
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
outcome measures
Primary Outcome Measures: 1. gait velocity [ Time Frame: 5 minutes ]
comfortable gait velocity on the treadmill
Secondary Outcome Measures: 1. step length variability [ Time Frame: 5 minutes ]
registration on the treadmill
2. step frequency [ Time Frame: 5 minutes ]
registration on the treadmill
3. step length [ Time Frame: 5 minutes ]
registration on the treadmill
4. step length asymmetry [ Time Frame: 5 minutes ]
registration on the treadmill
5. shortest step side [ Time Frame: 5 minutes ]
registration on the treadmill

Eligibility Criteria
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
Contacts
Locations
France, Isere CHU Grenoble Alpes La Tronche
Sponsors and Collaborators
University Hospital, Grenoble
Investigator
More Information
Other 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.

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.

Responsible Party : University Hospital, Grenoble
ClinicalTrials.gov Identifier : NCT03938363     
Other Study ID Numbers : 38RC18.107, 2019-A00502-55
First Posted : May 6, 2019
Last Update Posted : March 29, 2021
Last Verified : March 2021
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble: botulinum toxin
cervical dystonia
blepharospasm
gait parameters
Additional relevant MeSH terms :
Dystonic Disorders
Blepharospasm
Dystonia
Torticollis