Cervical Dystonia, PrimaryGAIT-TOXNCT03938363
Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia
A study testing Treadmill, Botulinum Toxin injection and Severity scale of the disease in people with Cervical Dystonia, Primary and Blepharospasm, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Dystonia, Primary, Blepharospasm
- What is being tested?
- Treadmill, Botulinum Toxin injection and Severity scale of the disease
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2019to 13 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analyse de la Marche de Patients Atteints de Dystonie Focale Avant et après Traitement Par Toxine Botulique
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.
- Conditions
- Cervical Dystonia, Primary, Blepharospasm
- Being tested
- Treadmill, Botulinum Toxin injection, Severity scale of the disease
- Keywords
- cervical dystonia, blepharospasm, gait parameters, botulinum toxin
- Medical subject headings
- Cervical Dystonia, Primary, Blepharospasm, Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreadmillOther
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
Botulinum Toxin injectionDrug
Also called Injection
injection of Botulinum Toxin in the two groups of CD and BS
Severity scale of the diseaseDiagnostic test
Also called Scale
JRS for BS TWSTRS for CD
| Study group | Role | What they receive |
|---|---|---|
| Cervical Dystonia (CD) | Experimental | Patients with cervical dystonia Receives: 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 Receives: Other: Treadmill |
| Blepharospasm (BS) | Experimental | Patients with blepharospasm Receives: 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 Receives: Other: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait velocity
comfortable gait velocity on the treadmill
Measured: 5 minutes
Secondary outcomes (5)
step frequency
registration on the treadmill
Measured: 5 minutes
step length
registration on the treadmill
Measured: 5 minutes
step length asymmetry
registration on the treadmill
Measured: 5 minutes
shortest step side
registration on the treadmill
Measured: 5 minutes
step length variability
registration on the treadmill
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start23 Oct 2019
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical Dystonia, PrimaryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938363
- Sponsor's protocol ID
- 38RC18.107
- Other IDs
- 2019-A00502-55
- Acronym
- GAIT-TOX
- Status last verified
- Dec 2025
- First submitted
- 2 May 2019
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 16928997Barr 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 28412603Albanese 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 23649720Cuinat 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyse de la Marche de Patients Atteints de Dystonie Focale Avant et après Traitement Par Toxine Botulique
- ClinicalTrials.gov ID
- NCT03938363
- Acronym / sponsor ID
- GAIT-TOX / 38RC18.107
- Conditions
- Cervical Dystonia, Primary, Blepharospasm
- Keywords
- cervical dystonia, blepharospasm, gait parameters, botulinum toxin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cervical Dystonia (CD) | Experimental | Other: Treadmill, Drug: Botulinum Toxin injection, Diagnostic Test: Severity scale of the diseasePatients with cervical dystonia |
| Healthy Control CD | Placebo comparator | Other: TreadmillCD age- and sex-matched healthy control subjects |
| Blepharospasm (BS) | Experimental | Other: Treadmill, Drug: Botulinum Toxin injection, Diagnostic Test: Severity scale of the diseasePatients with blepharospasm |
| Healthy Control BS | Placebo comparator | Other: TreadmillBS age- and sex-matched healthy control subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreadmillWalk 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 | Other | Blepharospasm (BS), Cervical Dystonia (CD), Healthy Control BS, Healthy Control CD |
| Botulinum Toxin injectionAlso: Injectioninjection of Botulinum Toxin in the two groups of CD and BS | Drug | Blepharospasm (BS), Cervical Dystonia (CD) |
| Severity scale of the diseaseAlso: ScaleJRS for BS TWSTRS for CD | Diagnostic test | Blepharospasm (BS), Cervical Dystonia (CD) |
Primary outcome
gait velocity
Time frame: 5 minutes
comfortable gait velocity on the treadmill
5 secondary outcomes
step frequency
Time frame: 5 minutes
step length
Time frame: 5 minutes
step length asymmetry
Time frame: 5 minutes
shortest step side
Time frame: 5 minutes
step length variability
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Background: PubMed 16928997Tarsy D, Simon DK. Dystonia. N Engl J Med. 2006 Aug 24;355(8):818-29. doi: 10.1056/NEJMra055549. No abstract available.
- Background: PubMed 28412603Barr 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.
- Background: PubMed 23649720Albanese 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 publication: PubMed 38386480Cuinat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill, Botulinum Toxin injection and Severity scale of the disease in people with Cervical Dystonia, Primary and Blepharospasm, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait velocity (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03938363, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.