Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Co-treatment, Individual Treatment.
- Who it may be relevant to
- Registry conditions: Stroke, Stroke Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. - Other Individual Treatment
Participants in this arm will be evaluated and treated by PT and OT individually for the duration of their hospitalization.
Primary outcome measures
- 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 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.]
Secondary outcome measures (1)
- Discharge Disposition [Time frame: At time of discharge.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
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 PMID 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. PMID 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. PMID 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. PMID 33125475
- O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56. PMID 497341
Identifiers
NCT: NCT07411534 · 251290