The Effects of Early and Late Injection of Botulinum Toxin Type A on Upper Limb Function in Patients With Stroke

NCT ID: NCT02580838

Last Updated: 2022-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2025-09-30

Brief Summary

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The aim of this study is to determine whether early use of OnabotulinumtoxinA is more effective to improve functional outcomes of upper limb in patients with stroke.

Detailed Description

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Many patients surviving stroke have significant impairment of function in the affected upper limb due to the development of spasticity. Botulinum toxin type A injection is a powerful treatment option for control of spasticity. In this study, the patients will be randomly assigned into three groups: early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention. The aim of this randomized controlled study is to evaluate the effects of early and late injection of botulinum toxin type A on upper limb function in patients with stroke.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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early OnabotulinumtoxinA group

OnabotulinumtoxinA will be injected immediately when spasticity develop in early OnabotulinumtoxinA group.

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

Early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention.

late OnabotulinumtoxinA group

OnabotulinumtoxinA will be injected at 6 months after emergence of spasticity in late OnabotulinumtoxinA group.

Group Type ACTIVE_COMPARATOR

OnabotulinumtoxinA

Intervention Type DRUG

Early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention.

no OnabotulinumtoxinA group

OnabotulinumtoxinA will not be injected for this group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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OnabotulinumtoxinA

Early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention.

Intervention Type DRUG

Other Intervention Names

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Botox

Eligibility Criteria

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Inclusion Criteria

* stroke affecting one body side
* spasticity develops after stroke

Exclusion Criteria

* musculoskeletal conditions that affected upper limb function prior to stroke
* concurrent use of anti-spasticity medications
* patients with neuromuscular junction or myopathic disorders such as myasthenia gravis or others
* patients with a known allergy to any onabotulinumtoxinA or to any of the excipients of onabotulinumtoxinA (such as human serum albumin)
* patients who are pregnant or may become pregnant at the time of the proposed injection
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Lin

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Locations

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Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Richard Lin

Role: CONTACT

886-6-2353535 ext. 2666

Richard Lin

Role: CONTACT

Facility Contacts

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Richard Lin

Role: primary

Tel: 886-6-2353535 ext. 2666

Other Identifiers

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B-BR-102-032

Identifier Type: -

Identifier Source: org_study_id

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