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

Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT02275312
Collaborator
(none)
110
Enrollment
17
Locations
36
Actual Duration (Months)
6.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    110 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    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.
    Actual Study Start Date :
    Jul 1, 2014
    Actual Primary Completion Date :
    Jul 1, 2017
    Actual Study Completion Date :
    Jul 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Change in Goal Attainment Scale (GAS) score. [Baseline, 16 months]

    Secondary Outcome Measures

    1. 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

    2. Change in Modified Ashworth Scale (MAS) score. [Baseline, 16 months]

    3. Baseline characteristics of patients [Baseline]

      Demographic characteristics

    4. Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score. [From baseline up to 16 months]

    5. Change in pain according to Visual Analog Scale (VAS). [Baseline, 16 months]

    6. Passive function of upper and/or lower limbs according to primary treatment target (PTT) from the disability assessment scale (DAS). [Baseline, 16 months]

    7. Comfortable barefoot walking speed, measured with the 10-meter walking speed test. [Baseline, 16 months]

    8. Change on EQ-5D quality of life questionnaire [Baseline, 16 months]

    9. Estimation of use of healthcare resources and costs associated with management of spasticity. [From baseline up to 16 months]

    10. Time interval between injections [From baseline up to 16 months]

    11. Cost per patient [From baseline up to 16 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barcelona Spain
    2 Bilbao Spain
    3 Cadiz Spain
    4 Cordoba Spain
    5 Granada Spain
    6 Huelva Spain
    7 Las Palmas De G.C. Spain
    8 Lleida Spain
    9 Madrid Spain
    10 Murcia Spain
    11 Palma de mallorca Spain
    12 Pontevedra Spain
    13 Salamanca Spain
    14 San Sebastián Spain
    15 Santiago Spain
    16 Sevilla Spain
    17 Valladolid Spain

    Sponsors and Collaborators

    • Ipsen

    Investigators

    • Study Director: Ipsen Medical Director, Ipsen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ipsen
    ClinicalTrials.gov Identifier:
    NCT02275312
    Other Study ID Numbers:
    • A-92-52120-192
    First Posted:
    Oct 27, 2014
    Last Update Posted:
    Aug 16, 2019
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:
    Muscle Spasticity

    Study Results

    No Results Posted as of Aug 16, 2019