HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
NCT ID: NCT00276185
Last Updated: 2011-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2005-12-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Spastic Cocontractions and Limitation of Active Movements Before and After Treatment During Injection of Botulinum Toxin
NCT03453008
Botulinum Toxin Applications in Hemiplegic Patients
NCT07240337
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke
NCT01392300
Upper-limb Active Function and Botulinum Toxin a
NCT03783572
Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity
NCT02757404
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Time delay treatment of botulinum toxin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Spastic hemiplegia after ischemic stroke (carotid occlusion) within the past 3 months.
* Antispasticity medication stabilized for the last 30 days
* Severe cognitive impairment such that patient is unable to provide scale assessment.
* Significant spasticity impeding improvement by re-education for 2 months or less
* Lack of muscular retraction defined by a minimal range of articular motion as :
* finger : complete extension and rolling up
* wrist : extension 40°/flexion : 45°
* elbow : extension - 10°/flexion : 120°
* shoulder : Enjalbert score 2 or more
* Antagonist muscles (to spasticity) activity score 1 or more
* Social Security benefits
Exclusion Criteria
* Known motor neuron or neuromuscular junction disease, disorders in which pain limits the ability to inject muscles (algodystrophy)
* Absence of mobility in proximal part of upper limb that does not predict a functional gain
* Minor stroke with non-disabling deficit or rapidly improving motor symptoms
* other serious illness, e.g. severe hepatic, cardiac, or renal failure ; acute myocardial infarction ; or a complex disease that may confound treatment assessment
* Treatment of spasticity by previous administration of botulinum toxin, if known
* Known allergy to botulinum toxin
* Currently participating in other research studies
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
J. Rebeyrol Hospital in Limoges
UNKNOWN
Rennes University Hospital
OTHER
Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes)
UNKNOWN
Saint Jacques Hospital in Nantes
UNKNOWN
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers
UNKNOWN
Centre Hospitalier Universitaire de Besancon
OTHER
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
CHU Clermont-Ferrand
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Franck Durif
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Franck Durif
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Franck Durif
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Wissel J, Muller J, Dressnandt J, Heinen F, Naumann M, Topka H, Poewe W. Management of spasticity associated pain with botulinum toxin A. J Pain Symptom Manage. 2000 Jul;20(1):44-9. doi: 10.1016/s0885-3924(00)00146-9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHU63-0003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.