ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity

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

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-07-31

Brief Summary

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The objective of this study is to evaluate the effectiveness of BoNT-A on functional improvement in patients with post-stroke upper and/or lower limb spasticity in the early stage of spasticity development, according to routine clinical practice.

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Detailed Description

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Conditions

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Spasticity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Men and women ≥ 18-80 years.
* Poststroke limb spasticity.
* Patients who have suffered a stroke in the previous 6 months.
* Treatment goal has been previously agreed with the patient or their legal representative.
* Patients with clinically significant poststroke upper/lower limb spasticity, in whom it has been decided to perform multidisciplinary treatment with BoNT-A + rehabilitation.
* No previous treatment with BoNT-A.
* Patient is able to follow the protocol.
* Written informed consent.

Exclusion Criteria

* Neuromuscular disease.
* Use of drugs that interfere with neuromuscular transmission.
* Any other condition that could interfere with rehabilitation or evaluation of the results.
* Diagnosis of spasticity not associated with stroke.
* Pregnant or nursing mothers.
* Prior participation in any other study in the 6 months before study entry

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No