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NCT Number: NCT07411534

Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Co-treatment

Other

Patients in this arm will be evaluated and treated by PT and OT at the same time for the duration of their hospitalization.

Individual Treatment

Other

Participants in this arm will be evaluated and treated by PT and OT individually for the duration of their hospitalization.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kaitlyn R Whitaker, MS

CONTACT

[email protected]

(615) 421-4224

Sarah A Welch, DO, MPH

CONTACT

[email protected]

615-322-1294

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: ICARE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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