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Completed

NCT Number: NCT02275312

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

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.

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Key information

Conditions

Spasticity Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Goal Attainment Scale (GAS) score.

    Time frame: Baseline, 16 months

Secondary outcomes

  1. Spasticity patterns will be defined in patients with upper and/or lower limb spasticity in the early stage after stroke

    Time frame: 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.

    Time frame: Baseline, 16 months

  3. Baseline characteristics of patients

    Time frame: Baseline

    Demographic characteristics

  4. Percentage of patients reporting functional improvement evaluated by Goal Attainment Scale (GAS) score.

    Time frame: From baseline up to 16 months

  5. Change in pain according to Visual Analog Scale (VAS).

    Time frame: Baseline, 16 months

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

    Time frame: Baseline, 16 months

  7. Comfortable barefoot walking speed, measured with the 10-meter walking speed test.

    Time frame: Baseline, 16 months

  8. Change on EQ-5D quality of life questionnaire

    Time frame: Baseline, 16 months

  9. Estimation of use of healthcare resources and costs associated with management of spasticity.

    Time frame: From baseline up to 16 months

  10. Time interval between injections

    Time frame: From baseline up to 16 months

  11. Cost per patient

    Time frame: From baseline up to 16 months

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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.

Acronym: ETREAT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2014
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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