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Enrolling by invitationNCT07411534ICAREUpdated Sep 11, 2026

Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation

An interventional study of Co-treatment and Individual Treatment in Stroke and Stroke Acute, sponsored by Vanderbilt University Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
567
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Stroke
  • Stroke Acute

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03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 567 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
567 participants (estimated)

Study arms

  • Active comparator
    Co-treatment

    Other: Co-treatment

  • Active comparator
    Individual Treatment

    Other: Individual Treatment

Interventions

  • OtherCo-treatment

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

  • OtherIndividual Treatment

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

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What researchers measure

Primary outcomes

  1. Final Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Score

    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.

    Time frame: Prior to discharge or at 28 days post-enrollment, whichever comes first.

  2. Final Activity Measure for Post-Acute Care (AM-PAC) Daily Activity Score

    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

    Time frame: Prior to hospital discharge or at 28 days post-enrollment, whichever comes first.

Secondary outcomes

  1. Discharge Disposition

    The final discharge destination of the patient when they leave the hospital, including discharge to home and post-acute care facilities.

    Time frame: At time of discharge.

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Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37203, United States
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References and documents

Publications

  • Martin SS, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Barone Gibbs B, Beaton AZ, Boehme AK, Commodore-Mensah Y, Currie ME, Elkind MSV, Evenson KR, Generoso G, Heard DG, Hiremath S, Johansen MC, Kalani R, Kazi DS, Ko D, Liu J, Magnani JW, Michos ED, Mussolino ME, Navaneethan SD, Parikh NI, Perman SM, Poudel R, Rezk-Hanna M, Roth GA, Shah NS, St-Onge MP, Thacker EL, Tsao CW, Urbut SM, Van Spall HGC, Voeks JH, Wang NY, Wong ND, Wong SS, Yaffe K, Palaniappan LP; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. 2024 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2024 Feb 20;149(8):e347-e913. doi: 10.1161/CIR.0000000000001209. Epub 2024 Jan 24. PubMed 38264914 ↗
  • E Wurzinger H, Abzhandadze T, Rafsten L, Sunnerhagen KS. Dependency in Activities of Daily Living During the First Year After Stroke. Front Neurol. 2021 Nov 8;12:736684. doi: 10.3389/fneur.2021.736684. eCollection 2021. PubMed 34819908 ↗
  • Bernhardt J, Churilov L, Ellery F, Collier J, Chamberlain J, Langhorne P, Lindley RI, Moodie M, Dewey H, Thrift AG, Donnan G; AVERT Collaboration Group. Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT). Neurology. 2016 Jun 7;86(23):2138-45. doi: 10.1212/WNL.0000000000002459. Epub 2016 Feb 17. PubMed 26888985 ↗
  • Wang CY, Chen YC, Wang CH. Early Rehabilitation in Acute Care Inpatient Wards May Be Crucial to Functional Recovery 3 Months After Ischemic Stroke. Phys Ther. 2021 Jan 4;101(1):pzaa197. doi: 10.1093/ptj/pzaa197. PubMed 33125475 ↗
  • O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56. PubMed 497341 ↗

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.

Supporting information: Study protocol, Sap, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07411534
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Sarah Welch (Assistant Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Feb 17, 2026
Start date
Sep 2, 2026
Primary completion
Sep 28, 2027 (estimated)
Completion
Dec 28, 2027 (estimated)
Last update
Sep 11, 2026

Study contacts

Sarah A Welch, DO, MPH
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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