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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT00276185

Collaborator

J. Rebeyrol Hospital in Limoges (Other), Rennes University Hospital (Other), Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes) (Other), Saint Jacques Hospital in Nantes (Other), Centre Hospitalier Universitaire de Saint Etienne (Other), Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers (Other), Centre Hospitalier Universitaire de Besancon (Other)

180

Enrollment

Location

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hemiplegia	Drug: Time delay treatment of botulinum toxin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, 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

Study Start Date :

Dec 1, 2005

Anticipated Primary Completion Date :

Jan 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Clermont-Ferrand University Hospital	Clermont-Ferrand	Auvergne	France	63000

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