StrokeICARENCT07411534
Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation
A study testing Co-treatment and Individual Treatment in people with Stroke and Stroke Acute, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke Acute
- What is being tested?
- Co-treatment and Individual Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 567 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2026to 28 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient admission to the neurology stroke service AND
- Orders placed for both PT and OT within 96 hours of hospital admission
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
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.
- Conditions
- Stroke, Stroke Acute
- Being tested
- Co-treatment, Individual Treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-treatmentOther
Patients in this arm will be evaluated and treated by PT and OT at the same time for the duration of their hospitalization.
Individual TreatmentOther
Participants in this arm will be evaluated and treated by PT and OT individually for the duration of their hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Co-treatment | Active comparator | Not described Receives: Other: Co-treatment |
| Individual Treatment | Active comparator | Not described Receives: Other: Individual Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to discharge or at 28 days post-enrollment, whichever comes first.
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
Measured: 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.
Measured: At time of discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start2 Sep 2026
- Primary completion28 Sep 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 567 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Welch, Vanderbilt University Medical Center
- Investigators
- Sarah A Welch, DO, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411534
- Sponsor's protocol ID
- 251290
- Acronym
- ICARE
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
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 38264914E 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 34819908Bernhardt 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 26888985Wang 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 33125475O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
PubMed 497341
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation
- ClinicalTrials.gov ID
- NCT07411534
- Acronym / sponsor ID
- ICARE / 251290
- Conditions
- Stroke, Stroke Acute
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 567 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-treatment | Active comparator | Other: Co-treatment |
| Individual Treatment | Active comparator | Other: Individual Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inpatient admission to the neurology stroke service AND
- Orders placed for both PT and OT within 96 hours of hospital admission
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-treatmentPatients in this arm will be evaluated and treated by PT and OT at the same time for the duration of their hospitalization. | Other | Co-treatment |
| Individual TreatmentParticipants in this arm will be evaluated and treated by PT and OT individually for the duration of their hospitalization. | Other | Individual Treatment |
Primary outcome
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.
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
1 secondary outcome
Discharge Disposition
Time frame: At time of discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 38264914Martin 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.
- Background: PubMed 34819908E 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.
- Background: PubMed 26888985Bernhardt 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.
- Background: PubMed 33125475Wang 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.
- Background: PubMed 497341O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah A Welch, DO, MPH principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-treatment and Individual Treatment in people with Stroke and Stroke Acute, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07411534, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.