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

NCT03938363 | Completed

• 2 other identifiers: 38RC18.1072019-A00502-55
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Dystonia, Primary; Blepharospasm

Keywords

cervical dystonia; blepharospasm; gait parameters; botulinum toxin

Outcome Measures

Primary Outcomes (1)

• gait velocity

  comfortable gait velocity on the treadmill

  5 minutes

Secondary Outcomes (5)

• step frequency

  5 minutes

• step length

  5 minutes

• step length asymmetry

  5 minutes

• shortest step side

  5 minutes

• step length variability

  5 minutes

Study Arms (4)

Cervical Dystonia (CD)

EXPERIMENTAL

Patients with cervical dystonia

Other: Treadmill; Drug: Botulinum Toxin injection; Diagnostic Test: Severity scale of the disease

Healthy Control CD

PLACEBO COMPARATOR

CD age- and sex-matched healthy control subjects

Other: Treadmill

Blepharospasm (BS)

EXPERIMENTAL

Patients with blepharospasm

Other: Treadmill; Drug: Botulinum Toxin injection; Diagnostic Test: Severity scale of the disease

Healthy Control BS

PLACEBO COMPARATOR

BS age- and sex-matched healthy control subjects

Other: Treadmill

Interventions

Treadmill OTHER

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

Blepharospasm (BS); Cervical Dystonia (CD); Healthy Control BS; Healthy Control CD

Botulinum Toxin injection DRUG

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

Also known as: Injection

Blepharospasm (BS); Cervical Dystonia (CD)

Severity scale of the disease DIAGNOSTIC_TEST

JRS for BS TWSTRS for CD

Also known as: Scale

Blepharospasm (BS); Cervical Dystonia (CD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 under guardianship or having curators (major protected)
• Subject under administrative or judicial supervision
• Subject not able to be contacted in case of emergency

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

La Tronche, Isere, 38700, France

Location

Related Publications (4)

• Tarsy D, Simon DK. Dystonia. N Engl J Med. 2006 Aug 24;355(8):818-29. doi: 10.1056/NEJMra055549. No abstract available.

  PMID: 16928997 BACKGROUND

• 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.

  PMID: 28412603 BACKGROUND

• 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.

  PMID: 23649720 BACKGROUND

• 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.

  PMID: 38386480 RESULT

MeSH Terms

Conditions

Cervical Dystonia, Primary; Blepharospasm; Torticollis

Interventions

Exercise Test; Botulinum Toxins; Injections

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: October 23, 2019
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (1)