Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inpatient admission to the neurology stroke service AND
Orders placed for both PT and OT within 96 hours of admission to the service
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Co-treatment
Other interventionPatients in this arm will be evaluated and treated by PT and OT at the same time for the duration of their hospitalization.
Individual Treatment
Other interventionParticipants in this arm will be evaluated and treated by PT and OT individually for the duration of their hospitalization.
Treatment groups
567 Participants
are divided into 2 treatment groupsGroup A: Co-treatmentActive comparator 1 intervention
Group B: Individual TreatmentActive comparator 1 intervention
Trial outcomes
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: