Co-treatment vs Individual Treatment for Stroke

(ICARE Trial)

SA
KR
Overseen ByKaitlyn R Whitaker, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two therapy approaches for stroke recovery. One approach involves patients receiving physical and occupational therapy together (co-treatment), while the other involves receiving them separately (individual treatment). The goal is to determine which method aids better recovery during acute care rehabilitation. Candidates may qualify for this trial if they are hospitalized for a stroke and have been ordered to start both physical and occupational therapy within four days of admission. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance stroke recovery therapies for future patients.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both combined and individual treatments in stroke recovery are generally well-received by patients.

For combined treatments, specific information on side effects is limited. However, studies have indicated that collaborative methods in stroke therapy enhance accessibility and quality without major safety concerns. This suggests safety, as no serious problems have been reported.

Individual treatments also maintain a strong safety record. Research has found that personalized stroke treatments reduce the chance of negative outcomes without major safety issues, indicating safety for participants.

In summary, both treatment methods appear safe for stroke recovery, with no major safety concerns reported in existing studies.12345

Why are researchers excited about this trial?

Researchers are excited about the trial comparing co-treatment and individual treatment for stroke recovery. Unlike standard care options that often focus on individual therapies, co-treatment involves simultaneous therapies, potentially enhancing recovery by addressing multiple aspects of stroke damage at once. This integrated approach might lead to faster and more comprehensive rehabilitation, sparking interest for its potential to improve outcomes beyond what single-treatment strategies typically offer.

What evidence suggests that this trial's treatments could be effective for stroke?

This trial will compare Co-treatment, where multiple therapists collaborate with a patient, and Individual Treatment, which emphasizes personalized care, for stroke recovery. Studies have shown that group therapy can enhance arm and hand movement during hospital rehabilitation. Meanwhile, individual therapy significantly improves a patient's ability to manage self-care and daily activities. Both methods offer strengths, but research suggests that increasing the accessibility and quality of therapy can be beneficial. Overall, patients who receive structured rehabilitation generally experience better outcomes.46789

Who Is on the Research Team?

SA

Sarah A Welch, DO, MPH

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I was admitted to the neurology stroke unit and had PT and OT ordered within 4 days.

Exclusion Criteria

Patient is known to be a prisoner
Patient is known to be pregnant
My doctor has decided I need or should not have physical or occupational therapy.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either individual or co-treatment physical and occupational therapy sessions

Up to 4 weeks
Sessions conducted regularly during hospital stay

Follow-up

Participants are monitored for functional outcomes and discharge disposition

Up to 4 weeks or until discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Co-treatment
  • Individual Treatment

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Co-treatmentActive Control1 Intervention
Group II: Individual TreatmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Citations

Effectiveness of care coordination interventions delivered to ...

This systematic review will identify the key components of stroke care coordination interventions implemented in low and middle-income countries (LMICs)

Using co-production to increase activity in acute stroke ... - NCBI

We aimed to evaluate (1) whether or not co-production approaches can be used to improve the accessibility and quality of therapeutic activity in acute stroke ...

A real-world propensity-matched cohort study

The primary outcome was improvement in upper-limb motor function during the inpatient rehabilitation period, assessed by the change in Fugl-Meyer Assessment ( ...

Individual vs Co-Treatment in Acute Stroke Rehabilitation and ...

Studies have shown that patients with stroke who participate in hospital PT and OT have improved function upon discharge. However, there is a ...

Most Promising Approaches to Improve Stroke Outcomes

Two pooled analyses of endovascular thrombectomy (EVT) randomized trials found a 20% to 27% absolute improvement in achieving independence after ...

Co-design for stroke intervention development - PMC - NIH

The following sections report the results of the data sources that explicitly used the term co-design. In total, 89 data sources (see Table 1), including 45 ...

Clinician-Reported Outcomes in Co-Primary Endpoint

Treatment varies depending on time from stroke onset and indications from brain imaging, but it can include medication to dissolve the blocking ...

Preliminary Results of a Co-Created Manualized Intervention ...

This study presents the feasibility and patient outcomes of a modified Healthy GOALS stroke intervention implemented in a skilled nursing ...

Outcomes and Safety of Revascularization Approaches for ...

Pittsburgh Outcomes After Stroke Thrombectomy Score Predicts Outcomes After Endovascular Therapy for Anterior Circulation Large Vessel ...