Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation

NCT07411534 | Not Yet Recruiting DMC

• 1 other identifier: 251290
• Study Type: interventional
• Target: 567
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke Acute

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Prior to hospital discharge or at 28 days post-enrollment, whichever comes first.

Secondary Outcomes (1)

• Discharge Disposition

  At time of discharge.

Study Arms (2)

Co-treatment

ACTIVE COMPARATOR

Other: Co-treatment

Individual Treatment

ACTIVE COMPARATOR

Other: Individual Treatment

Interventions

Co-treatment OTHER

Patients in this arm will be evaluated and treated by PT and OT at the same time for the duration of their hospitalization.

Co-treatment

Individual Treatment OTHER

Participants in this arm will be evaluated and treated by PT and OT individually for the duration of their hospitalization.

Individual Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatient admission to the neurology stroke service AND
• Orders placed for both PT and OT within 96 hours of admission to the service

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (5)

• 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.

  PMID: 38264914 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.

  PMID: 497341 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sarah A Welch, DO, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah A Welch, DO, MPH

CONTACT

615-322-1294; sarah.welch@vumc.org

Kaitlyn R Whitaker, MS

CONTACT

(615) 421-4224; katie.r.whitaker@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 28, 2027
• Study Completion (Estimated): December 28, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

Locations

US (1)