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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03938363
Other study ID # 38RC18.107
Secondary ID 2019-A00502-55
Status Completed
Phase N/A
First received
Last updated
Start date October 23, 2019
Est. completion date June 13, 2022

Study information

Verified date January 2023
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Description:

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Study Design


Intervention

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

Locations

Country Name City State
France CHU Grenoble Alpes La Tronche Isere

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary gait velocity comfortable gait velocity on the treadmill 5 minutes
Secondary step frequency registration on the treadmill 5 minutes
Secondary step length registration on the treadmill 5 minutes
Secondary step length asymmetry registration on the treadmill 5 minutes
Secondary shortest step side registration on the treadmill 5 minutes
Secondary step length variability registration on the treadmill 5 minutes
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