I-STROM Implementation for Stroke Rehabilitation

(I-STROM Trial)

Overseen By Lauren Wengerd, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Non-therapists, Non-Ohio license, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the measurement and use of stroke rehabilitation treatments by healthcare providers. It focuses on helping therapists adopt two specific tests for upper arm movement recovery. The trial will evaluate a package of strategies called I-STROM (a stroke rehabilitation program) to determine if they effectively encourage therapists to use these tests in various care settings. Occupational therapists in Ohio working with stroke patients may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative rehabilitation strategies that could enhance patient care.

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 prior data suggests that the I-STROM implementation is safe for stroke rehabilitation?

Research has shown that intensive and timely rehabilitation can greatly aid stroke recovery. However, specific safety information for the I-STROM treatment itself is not available. This study is in a "not applicable" phase, focusing on optimizing existing methods rather than testing a new drug or device. Since I-STROM is a technique designed to enhance rehabilitation practices, not a new medication or surgery, it is likely safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-STROM implementation for stroke rehabilitation because it introduces a novel approach to therapy that is integrated into different care settings: inpatient, acute care, and outpatient. Unlike traditional rehabilitation methods that often focus on physical therapy exercises alone, I-STROM aims to enhance recovery by utilizing a structured, standardized protocol that can be tailored to each care environment. This method could potentially streamline rehabilitation practices, making them more effective and consistent across various stages of patient care. By aligning the rehabilitation process seamlessly with the specific needs of each care setting, I-STROM has the potential to improve patient outcomes more efficiently than current standard practices.

What evidence suggests that I-STROM is effective for stroke rehabilitation?

Research has shown that standard tools like the Fugl-Meyer Assessment and the Action Research Arm Test are important for stroke recovery. These tools clearly and reliably track patient progress. This trial will evaluate the I-STROM intervention, which studies suggest can facilitate the use of these tools in stroke care. Consequently, I-STROM might enhance the tracking of recovery in stroke patients. By using these tools effectively, healthcare providers can offer more personalized and effective care for stroke recovery. ^{6 7 8 9 10}

Who Is on the Research Team?

Lisa Juckett, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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

Exclusion Criteria

Employees not involved in the evaluation/oversight of stroke survivor care

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• I-STROM

Trial Overview

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.

How Is the Trial Designed?

Group I: Outpatient Experimental Treatment 1 Intervention

Outpatient practitioners who will receive the I-STROM intervention

Group II: Inpatient Experimental Treatment 1 Intervention

Inpatient practitioners who will receive the I-STROM intervention

Group III: Acute care Experimental Treatment 1 Intervention

Acute care practitioners who will receive the I-STROM intervention

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

This study will analyze an intensive rehabilitation program for stroke patients over two years, focusing on the amount and types of therapies (physical, occupational, and speech therapy) provided, which is crucial for understanding effective rehabilitation practices.

Functional outcomes will be measured at multiple time points (baseline, discharge, and 3 and 6 months post-stroke) to assess the impact of the rehabilitation interventions on recovery, enhancing the validity of clinical trial results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive rehabilitation programme for patients with subacute stroke in an inpatient rehabilitation facility: describing a protocol of a prospective cohort study. Sartor, MM., Grau-Sánchez, J., Guillén-Solà, A., et al.[2021]

Younger and less disabled stroke patients tend to have better survival rates and outcomes, while those with dementia or pressure ulcers at admission face worse prognoses.

Starting rehabilitation within 7 days after a stroke significantly improves long-term outcomes compared to starting after 15 days or more, highlighting the importance of early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early and long-term outcome of rehabilitation in stroke patients: the role of patient characteristics, time of initiation, and duration of interventions. Musicco, M., Emberti, L., Nappi, G., et al.[2022]

The proposed rehabilitation method uses motion data from the unaffected arm of hemiplegic patients to control movements in the affected arm, potentially enhancing recovery through active participation.

The study demonstrated the effectiveness of this method by comparing motion data from inertial sensors with encoder values in a fabricated joint device, suggesting it can be applied to various upper limb rehabilitation robots.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study on the operation of rehabilitation interfaces in active rehabilitation exercises for upper limb hemiplegic patients: Interfaces for lateral and bilateral exercises. Eom, SH., Lee, EH.[2017]

A novel rehabilitation system using the Nintendo Wii remote showed promising results in upper-limb stroke rehabilitation, with participants reporting improved wrist control and greater functional use after a two-week case study.

The system's ability to provide real-time kinematic tracking and customizable exercises enhances patient engagement and motivation, suggesting it could be a valuable tool for therapists in both community and acute rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and preliminary evaluation of a novel low cost VR-based upper limb stroke rehabilitation platform using Wii technology. Tsekleves, E., Paraskevopoulos, IT., Warland, A., et al.[2022]

The SITAR system is a novel, sensor-based tool designed for independent assessment and rehabilitation of upper limb function, allowing patients to engage in task-oriented training with minimal therapist involvement.

Pilot studies show that patients can effectively use SITAR for various upper limb tasks, such as reaching and sensory resolution, and they find the system motivating, indicating its potential for enhancing rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SITAR: a system for independent task-oriented assessment and rehabilitation. Hussain, A., Balasubramanian, S., Roach, N., et al.[2023]

A randomized controlled trial involving 123 stroke patients found that an early increased-intensity upper limb therapy program did not lead to better outcomes compared to standard care, as measured by the Action Research Arm Test three months post-stroke.

Despite the intervention group receiving more total therapy time (median of 52 minutes/day) than the control group (38 minutes/day), the expected benefits were not realized, likely due to competitive therapy bias affecting the actual therapy received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an early increased-intensity interdisciplinary upper limb therapy programme following acute stroke improve outcome? Rodgers, H., Mackintosh, J., Price, C., et al.[2017]

A review of 491 randomized controlled trials (RCTs) on stroke rehabilitation identified 1447 outcomes assessed using 489 different measurement tools, highlighting a significant lack of consistency in outcome assessment.

The use of established assessment tools was linked to higher methodological quality in RCTs, suggesting that adopting standardized measures could improve the reliability of stroke rehabilitation research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome assessment in randomized controlled trials of stroke rehabilitation. Salter, KL., Teasell, RW., Foley, NC., et al.[2019]

Motor rehabilitation after stroke is defined as a process that helps individuals improve their motor function and daily life activities, particularly for those with residual disabilities, emphasizing the importance of personalized goals and regular assessments.

The rehabilitation process relies on learning and adaptation mechanisms, with early recovery linked to biological factors and later improvements achieved through compensatory strategies, highlighting the need for tailored, task-specific training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor rehabilitation after stroke: European Stroke Organisation (ESO) consensus-based definition and guiding framework. Kwakkel, G., Stinear, C., Essers, B., et al.[2023]

The Adaptive Mixed Reality Rehabilitation (AMRR) System effectively tracks and evaluates upper limb movements in stroke survivors, providing tailored multimedia feedback to enhance rehabilitation efforts.

Preliminary data from three participants indicate that the AMRR system can improve functional movement by training multiple aspects of movement simultaneously or individually, suggesting its potential for effective stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the bases for a mixed reality stroke rehabilitation system, Part II: design of interactive feedback for upper limb rehabilitation. Lehrer, N., Chen, Y., Duff, M., et al.[2021]

Early initiation of rehabilitation services and increased functional skills upon admission are strongly associated with better functional outcomes for stroke patients at hospital discharge and follow-up, based on a review of 79 studies from 1950 to 1998.

Rehabilitation in an interdisciplinary setting (where different types of healthcare professionals work together) is more effective than a multidisciplinary approach (where professionals work separately), while factors like specialized therapy types and therapy intensity show a weak relationship with improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors affecting functional outcome after stroke: a critical review of rehabilitation interventions. Cifu, DX., Stewart, DG.[2019]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04888416

Implementing Outcome Measures in Stroke Rehabilitation

At I-STROM conclusion, the study team will then extract data from another 30% of charts from the previous 12-months to identify pre-post effectiveness of I- ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11411918/

Bundling implementation strategies supports outcome ...

In stroke rehabilitation, standardized outcome measures such as the Fugl-Meyer Assessment of the Upper Extremity [6] are valid and reliable ...

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researchgate.net

researchgate.net/publication/384154970_Bundling_implementation_strategies_supports_outcome_measure_adoption_in_stroke_rehabilitation_preliminary_findings

Bundling implementation strategies supports outcome ...

Improving the use of standardized outcome measures is of paramount importance in stroke rehabilitation to objectively monitor patients' progress ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10741539/

Outcome Measures Utilized to Assess the Efficacy of ...

The current review assesses the literature related to TR for patients requiring post-stroke rehabilitation. The purpose of this study is to survey the outcome ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT01624402

Ecosystem Focused Therapy in Post Stroke Depression

This research study involves testing a modified form of problem-solving therapy called Ecosystem Focused Therapy (EFT) to help treat depression in older adult ...

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withpower.com

withpower.com/trial/phase-hemiplegia-9-2021-6564b

I-STROM Implementation for Stroke Rehabilitation · Info ...

While specific data on I-STROM is not provided, these findings imply that intensive and timely rehabilitation treatments can be beneficial for stroke recovery.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4362540/

The home stroke rehabilitation and monitoring system trial

The study statistician will submit descriptive performance data and safety data to the PIs and the Independent Medical Monitor for their review. The PI will ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1878747923008826

Invasive Neurostimulation in Stroke Rehabilitation

Cortical stimulation for the rehabilitation of patients with hemiparetic stroke: a multicenter feasibility study of safety and efficacy. J Neurosurg, 108 ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03168386

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Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there ...

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ahajournals.org

ahajournals.org/doi/10.1161/STROKEAHA.123.043164

Electric Field Navigated 1-Hz rTMS for Poststroke Motor ...

CONCLUSIONS: Intensive motor rehabilitation 3 to 12 months after stroke improved clinical impairment, function, and quality of life; however, 1 ...