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

3500 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

How 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. ^{6 7 8 9 10}

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.

Research Team

Lisa Juckett, PhD

Principal Investigator

Ohio State University

Eligibility 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

Exclusion Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Outcome assessment in randomized controlled trials of stroke rehabilitation. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Factors affecting functional outcome after stroke: a critical review of rehabilitation interventions. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Does an early increased-intensity interdisciplinary upper limb therapy programme following acute stroke improve outcome? [2017]

4. England 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. [2021]

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Motor rehabilitation after stroke: European Stroke Organisation (ESO) consensus-based definition and guiding framework. [2023]

7. England 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. [2021]

8. Netherlands 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. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Development and preliminary evaluation of a novel low cost VR-based upper limb stroke rehabilitation platform using Wii technology. [2022]

10. England pubmed.ncbi.nlm.nih.gov

SITAR: a system for independent task-oriented assessment and rehabilitation. [2023]