Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation (ICARE)

May 18, 2026 updated by: Sarah Welch, Vanderbilt University Medical Center
This is a single center, pragmatic, randomized trial comparing the effectiveness of two commonly used approaches (co-treatment and individual treatment) in acute care rehabilitation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Individual and co-treatment are both widely used to deliver physical therapy (PT) and occupational therapy (OT) for patients admitted to the hospital for acute stroke. Studies have shown that patients with stroke who participate in hospital PT and OT have improved function upon discharge. However, there is a lack of evidence informing which patients are best suited for individual versus co-treatment, or which delivery method more effectively improves functional outcomes.

This gap in knowledge presents a unique opportunity to advance stroke rehabilitation. This study aims to compare the two approaches and their resulting functional outcomes through a randomized trial-an approach never previously undertaken-to determine whether individual or co-treatment leads to better patient recovery. The findings have the potential to optimize rehabilitation and the delivery of PT and OT for future patients with acute stroke.

Study Type

Interventional

Enrollment (Estimated)

567

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sarah A Welch, DO, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inpatient admission to the neurology stroke service AND
  • Orders placed for both PT and OT within 96 hours of admission to the service

Exclusion Criteria:

  • Patient is known to be <18 years
  • Patient is known to be a prisoner
  • Patient is known to be pregnant
  • Prior evaluation or treatment by PT and/or OT while admitted under the stroke service before study enrollment
  • Clinician determines that either individual PT and OT or co-treatment is required or contraindicated for the optimal care of the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Individual Treatment
Other: Individual Treatment
Participants in this arm will be evaluated and treated by PT and OT individually for the duration of their hospitalization.
Active Comparator: Co-treatment
Other: Co-treatment
Patients in this arm will be evaluated and treated by PT and OT at the same time for the duration of their hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Score
Time Frame: Prior to discharge or at 28 days post-enrollment, whichever comes first.
Final PT assessment score. Assessments are conducted by PTs during every session on 6 mobility items: 1) turning over in bed 2) moving from lying to sitting edge of bed 3) moving from bed to chair 4) standing up from chair 5) walking in hospital room 6) climbing 3-5 steps. Therapists rate the patient's difficulty performing specified activities using a 4-point scale, with 1 indicating total assistance and 4 indicating no assistance needed. Scores from each of the 6 activities are totaled. Final scores range from 6-24, with lower scores indicating more severe impairment.
Prior to discharge or at 28 days post-enrollment, whichever comes first.
Final Activity Measure for Post-Acute Care (AM-PAC) Daily Activity Score
Time Frame: Prior to hospital discharge or at 28 days post-enrollment, whichever comes first.
Final OT assessment score. Assessments are conducted by OTs during every session on 6 activities including: 1) lower body dressing, 2) upper body dressing, 3) toileting, 4) grooming, 5) eating, 6) bathing. Therapists rate difficulty performing specified activities using a 4-point scale, with 1 indicating total assistance and 4 indicating no assistance needed. Scores from each of the 6 activities are totaled. Final scores range from 6-24, with lower scores indicating more severe impairment
Prior to hospital discharge or at 28 days post-enrollment, whichever comes first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discharge Disposition
Time Frame: At time of discharge.
The final discharge destination of the patient when they leave the hospital, including discharge to home and post-acute care facilities.
At time of discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Sarah A Welch, DO, MPH, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 28, 2027

Study Completion (Estimated)

December 28, 2027

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251290

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.

IPD Sharing Time Frame

The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.

IPD Sharing Access Criteria

Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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