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

Study Overview
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Brief Summary
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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).

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

Conditions
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Hemiplegia

Intervention / Treatment
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* Drug: Time delay treatment of botulinum toxin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Time delay treatment of botulinum toxin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of pain |  |  | 
| Individual functional kinesitherapy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spasticity ;, Botulinum toxin ;, Upper limb ;, motor function., spastic hemiplegia after stoke