Clinical trial NCT02275312: ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-stroke spasticity

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Goal Attainment Scale (GAS) score.
timeFrame: Baseline, 16 months
Secondary outcomes:
measure: Spasticity patterns will be defined in patients with upper and/or lower limb spasticity in the early stage after stroke
timeFrame: Baseline, 16 months
measure: Change in Modified Ashworth Scale (MAS) score.
timeFrame: Baseline, 16 months
measure: Baseline characteristics of patients
timeFrame: Baseline
measure: Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score.
timeFrame: From baseline up to 16 months
measure: Change in pain according to Visual Analog Scale (VAS).
timeFrame: Baseline, 16 months
measure: Passive function of upper and/or lower limbs according to primary treatment target (PTT) from the disability assessment scale (DAS).
timeFrame: Baseline, 16 months
measure: Comfortable barefoot walking speed, measured with the 10-meter walking speed test.
timeFrame: Baseline, 16 months
measure: Change on EQ-5D quality of life questionnaire
timeFrame: Baseline, 16 months
measure: Estimation of use of healthcare resources and costs associated with management of spasticity.
timeFrame: From baseline up to 16 months
measure: Time interval between injections
timeFrame: From baseline up to 16 months
measure: Cost per patient
timeFrame: From baseline up to 16 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Cadiz
country: Spain
city: Cordoba
country: Spain
city: Granada
country: Spain
city: Huelva
country: Spain
city: Las Palmas De G.C.
country: Spain
city: Lleida
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Palma de mallorca
country: Spain
city: Pontevedra
country: Spain
city: Salamanca
country: Spain
city: San Sebastián
country: Spain
city: Santiago
country: Spain
city: Sevilla
country: Spain
city: Valladolid
country: Spain
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: