Stroke, Stroke Acute
Conditions
Brief 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.
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
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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Score | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Discharge Disposition | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah A Welch, DO, MPH
Vanderbilt University Medical Center
Outcome results
None listed