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CompletedNCT03938363GAIT-TOXUpdated Dec 22, 2025

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

An interventional study of Treadmill and Botulinum Toxin injection in Cervical Dystonia, Primary and Blepharospasm, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Cervical Dystonia, Primary
  • Blepharospasm

Keywords

  • cervical dystonia
  • blepharospasm
  • gait parameters
  • botulinum toxin
03

In context

Blepharospasm

42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.

This study's enrollment of 40 is close to the median of 40 across 28 interventional studies indexed under Blepharospasm.

Browse Blepharospasm studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Cervical Dystonia (CD)

    Patients with cervical dystonia

    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

    Other: Treadmill

  • Experimental
    Blepharospasm (BS)

    Patients with blepharospasm

    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

    Other: Treadmill

Interventions

  • OtherTreadmill

    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

  • injection of Botulinum Toxin in the two groups of CD and BS

    Also known as: Injection

  • Diagnostic testSeverity scale of the disease

    JRS for BS TWSTRS for CD

    Also known as: Scale

06

What researchers measure

Primary outcomes

  1. gait velocity

    comfortable gait velocity on the treadmill

    Time frame: 5 minutes

Secondary outcomes

  1. step frequency

    registration on the treadmill

    Time frame: 5 minutes

  2. step length

    registration on the treadmill

    Time frame: 5 minutes

  3. step length asymmetry

    registration on the treadmill

    Time frame: 5 minutes

  4. shortest step side

    registration on the treadmill

    Time frame: 5 minutes

  5. step length variability

    registration on the treadmill

    Time frame: 5 minutes

07

Study locations

1 site
  • CHU Grenoble Alpes
    La Tronche, Isere 38700, France
08

References and documents

Publications

  • Tarsy D, Simon DK. Dystonia. N Engl J Med. 2006 Aug 24;355(8):818-29. doi: 10.1056/NEJMra055549. No abstract available. PubMed 16928997 ↗
  • 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. PubMed 28412603 ↗
  • 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. PubMed 23649720 ↗
  • Cuinat J, Debu B, Meoni S, Pelissier P, Castrioto A, Fraix V, Moro E. Spatiotemporal Gait Differences before and after Botulinum Toxin in People with Focal Dystonia: A Pilot Study. Mov Disord Clin Pract. 2024 Feb;11(2):143-151. doi: 10.1002/mdc3.13944. Epub 2023 Dec 14. PubMed 38386480 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03938363
Responsible party
Sponsor
First posted
May 6, 2019
Start date
Oct 23, 2019
Primary completion
Jun 13, 2022
Completion
Jun 13, 2022
Last update
Dec 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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