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
Recruitment status was Recruiting
Sponsor:
University Hospital, Clermont-Ferrand
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
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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 |
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
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 May 23, 2013