NCT07139444

Brief Summary

Physical therapy assessments assist in discharge planning along with demographic and social factors for patients with stroke in acute care. Understanding where a patient can be discharged to, based on the patient's functional status post stroke is important to be able to use resources effectively, decrease length of stay, and facilitate early initiation of rehabilitation services if needed. Standardized outcome measures can help quantify functional deficits and the scores on the standardized outcome measures can in turn guide the discharge planning process. The Activity Measure for Post Acute Care "6-Clicks" (AM-PAC "6-Clicks") has been used in the acute care setting to guide discharge planning. Based on its cutoff scores, it also can assist in predicting discharge destination. The Mobility Scale for Acute Stroke (MSAS) has been used to determine discharge to home versus not home in patients with stroke. Understanding the validity of the MSAS in comparison with the Postural Assessment Scale for Stroke (PASS) and the AM-PAC "6-Clicks" can be beneficial as the MSAS is a stroke specific outcome measure which is mainly used in acute care and is easy to administer. It can be administered in a short duration and consists of mobility and balance assessments which can help determine functional deficits.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 17, 2025

Last Update Submit

August 17, 2025

Conditions

Keywords

strokePASSAM-PAC "6-Clicks"MSASacute care hospitalphysical therapy outcome measures

Outcome Measures

Primary Outcomes (3)

  • Mobility Scale for Acute Stroke (MSAS)

    The MSAS is a six-item scale which consists of components that are routinely assessed in patients by physical therapists. The components are bridging, sit from supine and then return to supine, sitting balance to be held for 3 minutes, sit to stand from a chair without using arms, standing balance for 1 minute, and gait testing for 10 m with or without an assistive device. The scores for each domain range from 6 to 36. The cut off score is 26 with scores above 26 indicating possible discharge to home and below 26 indicating need for institutionalization.

    Baseline

  • Postural Assessment Scale for Stroke (PASS)

    The PASS consists of 12-items assessing balance ability to maintain postures or while changing postures. The score range for the PASS is 0 to 36 with lower scores indicating greater balance impairments. The 12 items consist of sitting without support, standing with support, standing without support, standing on nonparetic leg, standing on paretic leg, supine to paretic side lateral, supine to nonparetic side lateral, supine to sitting up on edge of the mat, sitting on the edge of the mat to supine, sitting to standing up, standing up to sitting down, and standing - picking up a pencil from the floor.

    Baseline

  • Activity Measure for Post-Acute Care "6-Clicks" (AM-PAC "6-Clicks")

    The AM-PAC was developed to assess activity level post-acute care. It consists of three domains - basic mobility, daily activity, and applied cognition and each of the three domains consists of six items. The raw scores for each domain range from 6 to 24. A higher raw score indicates less functional limitations. The cutoff score for medically complex patients is 42.9 for the basic mobility domain and 39.4 for the daily activity domain.

    Baseline

Secondary Outcomes (3)

  • Orpington Prognostic Scale (OPS)

    Baseline

  • Modified Rankin Scale (MRS)

    Baseline

  • Functional Comorbidity Index (FCI)

    Baseline

Interventions

A physical therapist will perform an evaluation which will consist of history taking and assessing the following: strength, endurance, range of motion, sitting/standing balance, sensory testing, and skin integrity. Following these assessments, the physical therapist will assess participant's functional mobility which involves assessing how you get out of bed, standing up, and walking. The physical therapist will also assess the participant on three tests which help determine your balance and assistance required with functional mobility. The tests that will be performed in no particular order are PASS, MSAS, AM-PAC "6-Clicks", OPS, MRS, and FCI. Data for the AM-PAC daily activity and applied cognition domains will be obtained from the patient's chart from the Occupational Therapy evaluation. Discharge destination information will be obtained from the PT evaluation and the discharge destinations will be acute/inpatient rehab, SAR, SNF, Home with or without home PT, and outpatient PT.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population of interest is individuals with acute stroke admitted to the neurology unit of New York Presbyterian Brooklyn Methodist hospital in New York. 532 patients with stroke were admitted to the hospital in the year 2022. Participants will be recruited based on a sample of convenience. All people with a diagnosis of stroke admitted to the neurology unit of the acute care hospital will be screened for participation using the medical record. Patients with stroke who meet the inclusion criteria will be offered the opportunity to participate in the research study. Patients who agree to participate will be provided with an informed consent form which will be signed by the patient or health care proxy. If a patient chooses not to participate in the study, the patient will still receive physical therapy services similar to the study participant.

You may qualify if:

  • Individuals who have a confirmed diagnosis of a first acute, single or multiple infarct, ischemic or hemorrhagic in nature by imaging.
  • Individuals who are 18 years of age or older.
  • Individuals must be non-institutionalized prior to hospital admission.
  • Individuals whose primary spoken and written language is English.
  • Individuals who are referred for physical therapy in acute care.

You may not qualify if:

  • Individuals who are non-ambulatory prior to hospital admission.
  • Individuals having a diagnosis of secondary major trauma or subarachnoid hemorrhage.
  • Individuals with any comorbidity that prevents him/her from completing the tests such as a previous neurological injury or recent orthopedic diagnoses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

MeSH Terms

Conditions

StrokeHemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Asad Siddiqi, DO

    New York Presbyterian Brooklyn Methodist Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aniketh M Chavan, DPT

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

August 17, 2025

First Posted

August 24, 2025

Study Start

September 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The data will be deidentified and will be saved on a password protected drive. In addition, only personnel who are associated with the study will have access to the study specific records in the database. For any adverse events that happen during the physical therapy assessment, they will be documented, and the medical team will be notified. A data transfer usage agreement will be established between Nova Southeastern University and New York Presbyterian Brooklyn Methodist Hospital.

Locations