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Implementing Outcome Measures in Stroke Rehabilitation

Study acronym: I-STROM
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of May 1, 2026 to May 31, 2026
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
    • Publications: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 2 words
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 3500 to confirmed 484
    • Study completion date: May 1, 2025 to May 1, 2026
    • Site details revised
    v6
  3. Notable Primary completion date: Mar 31, 2024 to Mar 31, 2025
    • Study completion date: May 1, 2024 to May 1, 2025
    v5
  4. Notable Primary completion date: Mar 31, 2023 to Mar 31, 2024
    • Study completion date: Aug 29, 2023 to May 1, 2024
    v4
  5. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Mar 2023 to Mar 31, 2023
    • Study completion date: Aug 2023 to Aug 29, 2023
    • Study description shortened, about 29 words
  6. Notable Start date: Jul 2021 to Oct 1, 2021
    • Primary completion date: Jan 2023 to Mar 2023
    • Study completion date: Jun 2023 to Aug 2023
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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The primary objective of this study is to tailor and test implementation strategies to support the adoption of two upper extremity motor outcome measures for stroke: the Fugl-Meyer Assessment and the Action Research Arm Test. The study's interdisciplinary team will address this objective through the following specific aims: (a) Tailor a package of implementation strategies (referred to as I-STROM-Implementation STRategies for Outcome Measurement) to promote outcome measure use across the care continuum, (b) Determine the effectiveness of I-STROM on outcome measure adoption and (c) Evaluate the appropriateness, acceptability, and feasibility of I-STROM in rehabilitation settings across the country. The mixed-methods study design is informed by implementation science methodologies, and the tailoring of I-STROM will be guided by input from stakeholders, including occupational therapy practitioners and administrators. The investigators will collect robust quantitative and qualitative data by means of retrospective chart reviews, electronic surveys, and stakeholder focus groups. This study, "Strategies to Promote the Implementation of Outcome Measures in Stroke Rehabilitation," will address core barriers to outcome measure use through a package of implementation strategies, thus laying the groundwork for I-STROM scale-up in health systems nationwide.
Trial Details
NCT Number NCT04888416
Lead Sponsor Ohio State University
Conditions
(from sponsor)
Stroke, Upper Extremity Dysfunction, Hemiplegia, Hemiparesis, Knowledge, Attitudes, Practice
Related terms Behavior, Hemiplegia, Paresis, Stroke
Enrollment 484 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov