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

Completed

• Conditions: Spasticity

• Registration Number: NCT02275312
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-27
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Goal Attainment Scale (GAS) score.	Baseline, 16 months

Secondary Outcome Measures

Name	Time	Method
Change in Modified Ashworth Scale (MAS) score.	Baseline, 16 months
Change on EQ-5D quality of life questionnaire	Baseline, 16 months
Time interval between injections	From baseline up to 16 months
Change in pain according to Visual Analog Scale (VAS).	Baseline, 16 months
Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score.	From baseline up to 16 months
Cost per patient	From baseline up to 16 months
Spasticity patterns will be defined in patients with upper and/or lower limb spasticity in the early stage after stroke	Baseline, 16 months	Descriptive statistics will be presented in addition to 95% confidence intervals for the mean and percentages
Baseline characteristics of patients	Baseline	Demographic characteristics
Passive function of upper and/or lower limbs according to primary treatment target (PTT) from the disability assessment scale (DAS).	Baseline, 16 months
Comfortable barefoot walking speed, measured with the 10-meter walking speed test.	Baseline, 16 months
Estimation of use of healthcare resources and costs associated with management of spasticity.	From baseline up to 16 months