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

Ipsen

Status: Completed

Conditions: Spasticity

Study type: Observational

Funder types: Industry

Identifiers

NCT02275312

A-92-52120-192

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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