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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

Primary Purpose

Hemiplegia

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Time delay treatment of botulinum toxin
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring spasticity ;, Botulinum toxin ;, Upper limb ;, motor function., spastic hemiplegia after stoke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clermont-Ferrand University HospitalRecruiting

Outcomes

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

Full Information

First Posted
January 12, 2006
Last Updated
January 18, 2011
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
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1. Study Identification

Unique Protocol Identification Number
NCT00276185
Brief Title
HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
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 Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
spasticity ;, Botulinum toxin ;, Upper limb ;, motor function., spastic hemiplegia after stoke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Time delay treatment of botulinum toxin
Primary Outcome Measure Information:
Title
Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
Title
Box and blocks test
Title
Enjalbert test
Title
Modified Ashworth scale (upper limb)
Title
Functional Independence Measure
Title
Fugl-Meyer upper limb test
Title
Clinical Global Impression (CGI)
Title
36-Item Short Form (SF-36) quality of life
Secondary Outcome Measure Information:
Title
Range of pain
Title
Individual functional kinesitherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Franck Durif
Phone
(33) 04 73 750 750
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Durif
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clermont-Ferrand University Hospital
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Durif
Phone
(33) 04 73 750 750

12. IPD Sharing Statement

Citations:
PubMed Identifier
10946168
Citation
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.
Results Reference
result

Learn more about this trial

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

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