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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00276185

Enrollment

180

Registered

2006-01-13

Start date

2005-12-31

Completion date

2009-12-31

Last updated

2011-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia

Keywords

spasticity ;, Botulinum toxin ;, Upper limb ;, motor function., spastic hemiplegia after stoke

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).

Interventions

DRUGTime delay treatment of botulinum toxin

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
36-Item Short Form (SF-36) quality of life	—
Fugl-Meyer upper limb test	—
Clinical Global Impression (CGI)	—
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	—

Secondary

Measure	Time frame
Individual functional kinesitherapy	—
Range of pain	—

Countries

France

Contacts

Primary ContactFranck Durif

(33) 04 73 750 750

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026