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HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
J. Rebeyrol Hospital in Limoges
Rennes University Hospital
Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes)
Saint Jacques Hospital in Nantes
Centre Hospitalier Universitaire de Saint Etienne
Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers
Centre Hospitalier Universitaire de Besancon
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00276185
First received: January 12, 2006
Last updated: January 18, 2011
Last verified: January 2011
  Purpose

Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (<or = 3 months) in spasticity improve functional and motor tests compared with late injections (>or = 6 months).


Condition Intervention Phase
Hemiplegia
Drug: Time delay treatment of botulinum toxin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
  • Box and blocks test
  • Enjalbert test
  • Modified Ashworth scale (upper limb)
  • Functional Independence Measure
  • Fugl-Meyer upper limb test
  • Clinical Global Impression (CGI)
  • 36-Item Short Form (SF-36) quality of life

Secondary Outcome Measures:
  • Range of pain
  • Individual functional kinesitherapy

Estimated Enrollment: 180
Study Start Date: December 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum age 18
  • 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:

  • Ischemic stroke thought to be due to basilar or vertebral vessel occlusion
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276185

Contacts
Contact: Franck Durif (33) 04 73 750 750

Locations
France
Clermont-Ferrand University Hospital Recruiting
Clermont-Ferrand, Auvergne, France, 63000
Contact: Franck Durif    (33) 04 73 750 750      
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
J. Rebeyrol Hospital in Limoges
Rennes University Hospital
Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes)
Saint Jacques Hospital in Nantes
Centre Hospitalier Universitaire de Saint Etienne
Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Franck Durif University Hospital, Clermont-Ferrand
  More Information

Publications:
Responsible Party: Pr Franck DURIF, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00276185     History of Changes
Other Study ID Numbers: CHU63-0003
Study First Received: January 12, 2006
Last Updated: January 18, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
spasticity ;
Botulinum toxin ;
Upper limb ;
motor function.
spastic hemiplegia after stoke

Additional relevant MeSH terms:
Hemiplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014