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

ETREAT: A Prospective Observational Study to Evaluate the Effectiveness of Botulinum Toxin Type A (BoNT-A) Injections in Patients With Post-stroke Upper and/or Lower Limb Spasticity in the Early Stage of Spasticity Development.

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.

Study Overview

• Status: Completed
• Conditions: Spasticity

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
  • Bilbao, Spain
  • Cadiz, Spain
  • Cordoba, Spain
  • Granada, Spain
  • Huelva, Spain
  • Las Palmas De G.C., Spain
  • Lleida, Spain
  • Madrid, Spain
  • Murcia, Spain
  • Palma de mallorca, Spain
  • Pontevedra, Spain
  • Salamanca, Spain
  • San Sebastián, Spain
  • Santiago, Spain
  • Sevilla, Spain
  • Valladolid, Spain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Post-stroke spasticity

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Goal Attainment Scale (GAS) score.	Baseline, 16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity patterns will be defined in patients with upper and/or lower limb spasticity in the early stage after stroke	Descriptive statistics will be presented in addition to 95% confidence intervals for the mean and percentages	Baseline, 16 months
Change in Modified Ashworth Scale (MAS) score.		Baseline, 16 months
Baseline characteristics of patients	Demographic characteristics	Baseline
Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score.		From baseline up to 16 months
Change in pain according to Visual Analog Scale (VAS).		Baseline, 16 months
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
Change on EQ-5D quality of life questionnaire		Baseline, 16 months
Estimation of use of healthcare resources and costs associated with management of spasticity.		From baseline up to 16 months
Time interval between injections		From baseline up to 16 months
Cost per patient		From baseline up to 16 months

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: A-92-52120-192