Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Location contact
Kaitlyn R Whitaker, MS
CONTACT
Sarah A Welch, DO, MPH
PRINCIPAL_INVESTIGATOR
Sydney Lagalante, MPH
CONTACT
NCT Number: NCT07411534
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37203, United States
Kaitlyn R Whitaker, MS
CONTACT
Sarah A Welch, DO, MPH
PRINCIPAL_INVESTIGATOR
Sydney Lagalante, MPH
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in this arm will be evaluated and treated by PT and OT at the same time for the duration of their hospitalization.
Participants in this arm will be evaluated and treated by PT and OT individually for the duration of their hospitalization.
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.
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
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.
Contact information is provided by the study sponsor or research team.
Kaitlyn R Whitaker, MS
CONTACT
Sarah A Welch, DO, MPH
CONTACT
Vanderbilt University Medical Center
Other
Acronym: ICARE
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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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