I-STROM Implementation for Stroke Rehabilitation
(I-STROM Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University
Disqualifiers: Non-therapists, Non-Ohio license, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment I-STROM for stroke rehabilitation?
The research suggests that increased intensity and early initiation of rehabilitation therapies, including physical, occupational, and speech therapy, are linked to better recovery outcomes in stroke patients. While specific data on I-STROM is not provided, these findings imply that intensive and timely rehabilitation treatments can be beneficial for stroke recovery.
12345How is the I-STROM treatment for stroke rehabilitation different from other treatments?
The I-STROM treatment for stroke rehabilitation is unique because it likely involves a novel approach or technology, such as interactive or virtual reality systems, which are designed to provide adaptive feedback and task-oriented training for upper limb rehabilitation. This approach may differ from traditional therapies by offering a more engaging and personalized rehabilitation experience.
678910Eligibility Criteria
This trial is for stroke patients who have received occupational therapy at OSUWMC, and for licensed occupational therapists or administrators involved in evaluating these patients. It excludes employees not engaged in the care evaluation of stroke survivors.Inclusion Criteria
Occupational therapist with license in Ohio or administrator who oversees therapists
I have had a stroke, received occupational therapy at OSUWMC, and was evaluated by an occupational therapist.
Employed at OSUWMC
+2 more
Exclusion Criteria
Employees not involved in the evaluation/oversight of stroke survivor care
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Baseline retrospective chart review and survey data collection to determine current use of outcome measures and perceptions of barriers
1 month
1 visit (in-person)
I-STROM Implementation
Implementation of I-STROM strategies including educational meetings, learning collaboratives, and outcome measure champions
12 months
Quarterly visits (in-person and virtual)
Follow-up
Posttest data collection and focus groups to assess changes in outcome measure adoption and stakeholder perceptions
1 month
1 visit (in-person)
Participant Groups
The study tests I-STROM strategies to encourage use of two upper extremity motor outcome measures (Fugl-Meyer Assessment and Action Research Arm Test) in stroke rehabilitation across various settings.
3Treatment groups
Experimental Treatment
Group I: OutpatientExperimental Treatment1 Intervention
Outpatient practitioners who will receive the I-STROM intervention
Group II: InpatientExperimental Treatment1 Intervention
Inpatient practitioners who will receive the I-STROM intervention
Group III: Acute careExperimental Treatment1 Intervention
Acute care practitioners who will receive the I-STROM intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ohio State University Wexner Medical CenterColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State UniversityLead Sponsor
References
Outcome assessment in randomized controlled trials of stroke rehabilitation. [2019]The lack of a unified approach to outcome assessment in stroke rehabilitation limits our ability to interpret evidence provided by randomized controlled trials (RCTs). The purpose of this review was to identify outcomes and assessment tools reported in RCTs of stroke rehabilitation interventions as a first step toward consistent assessment of outcomes. Given that the validity of research is linked to reliability and validity of measurement, the relationship between the use of previously developed outcome measures and the methodological quality of RCTs was explored. Electronic literature searches identified RCTs examining stroke rehabilitation therapies from 1968 to 2005. The Physiotherapy Evidence Database (PEDro) scale was used to assess methodological quality. Cited outcomes were recorded and assessment tools identified as previously published or study specific. Four hundred ninety-one RCTs cited the assessment of 1447 outcomes using 489 measurement tools. Two hundred fifty-four of these were previously published, and 235 were study specific. A core of 30 frequently cited tools was identified. The use of previously published assessment tools to evaluate primary study outcomes was associated with higher PEDro scores. Significant heterogeneity in outcome assessment was demonstrated, although a core of 30 frequently cited tools could be identified. Appropriate evaluation and selection of outcome measures would enhance the methodological quality of randomized controlled trials.
Factors affecting functional outcome after stroke: a critical review of rehabilitation interventions. [2019]A comprehensive review of the medical literature from 1950 to 1998 revealed 79 articles examining associations between rehabilitation interventions and functional outcome after stroke. This body of literature was critically analyzed, using established techniques, to reveal factors that were consistently associated with functional outcome after stroke. The following rehabilitation interventions after stroke appear to have a strong relationship with improved functional outcome at hospital discharge and follow-up: increased functional skills on admission to rehabilitation, early initiation of rehabilitation services, and rehabilitation in an interdisciplinary versus multidisciplinary setting. The following rehabilitation interventions after stroke appear to have a weak relationship with improved functional outcome at hospital discharge and follow-up: use of specialized types of therapy services and greater intensity of therapy services. The current literature is too limited to allow an assessment of the relationship of the following factors after stroke and functional outcome: specific types of non-inpatient rehabilitation services.
Does an early increased-intensity interdisciplinary upper limb therapy programme following acute stroke improve outcome? [2017]To determine whether an early increased-intensity upper limb therapy programme following acute stroke improves outcome.
Intensive rehabilitation programme for patients with subacute stroke in an inpatient rehabilitation facility: describing a protocol of a prospective cohort study. [2021]Rehabilitation is recognised as a cornerstone of multidisciplinary stroke care. Intensity of therapy is related to functional recovery although there is high variability on the amount of time and techniques applied in therapy sessions. There is a need to better describe stroke rehabilitation protocols to develop a better understanding of current practice increasing the internal validity and generalisation of clinical trial results. The aim of this study is to describe an intensive rehabilitation programme for patients with stroke in an inpatient rehabilitation facility, measuring the amount and type of therapies (physical, occupational and speech therapy) provided and reporting functional outcomes.
Early and long-term outcome of rehabilitation in stroke patients: the role of patient characteristics, time of initiation, and duration of interventions. [2022]To determine whether and how patient characteristics and the time of initiation and duration of rehabilitation influence early and long-term patient outcome after cerebrovascular accident.
Motor rehabilitation after stroke: European Stroke Organisation (ESO) consensus-based definition and guiding framework. [2023]To propose a consensus-based definition and framework for motor rehabilitation after stroke.
Exploring the bases for a mixed reality stroke rehabilitation system, Part II: design of interactive feedback for upper limb rehabilitation. [2021]Few existing interactive rehabilitation systems can effectively communicate multiple aspects of movement performance simultaneously, in a manner that appropriately adapts across various training scenarios. In order to address the need for such systems within stroke rehabilitation training, a unified approach for designing interactive systems for upper limb rehabilitation of stroke survivors has been developed and applied for the implementation of an Adaptive Mixed Reality Rehabilitation (AMRR) System.
A study on the operation of rehabilitation interfaces in active rehabilitation exercises for upper limb hemiplegic patients: Interfaces for lateral and bilateral exercises. [2017]For implementing autonomous rehabilitation exercises for upper limb hemiplegic patients, interfaces and a rehabilitation scenario that allow lateral and bilateral motions in a rehabilitation exercise robot are proposed.
Development and preliminary evaluation of a novel low cost VR-based upper limb stroke rehabilitation platform using Wii technology. [2022]This paper proposes a novel system (using the Nintendo Wii remote) that offers customised, non-immersive, virtual reality-based, upper-limb stroke rehabilitation and reports on promising preliminary findings with stroke survivors.
SITAR: a system for independent task-oriented assessment and rehabilitation. [2023]Over recent years, task-oriented training has emerged as a dominant approach in neurorehabilitation. This article presents a novel, sensor-based system for independent task-oriented assessment and rehabilitation (SITAR) of the upper limb.