Stroke, AcuteNCT07139444
Use of Physical Therapy Outcome Measures to Predict Discharge Destination in People With Stroke From Acute Care Hospital
An observational study of Stroke, Acute and Cerebrovascular Accident, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Acute, Cerebrovascular Accident, Stroke
- What is being tested?
- One time Physical Therapy Evaluation
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Aniketh M Chavan, DPT, 317-602-9203, dlx9003@nyp.org
About this study
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.
- Conditions
- Stroke, Acute, Cerebrovascular Accident, Stroke, Stroke Hemorrhagic
- Being tested
- One time Physical Therapy Evaluation
- Keywords
- stroke, PASS, AM-PAC "6-Clicks", MSAS, acute care hospital, physical therapy outcome measures
- Medical subject headings
- Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One time Physical Therapy EvaluationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
Orpington Prognostic Scale (OPS)
The OPS consists of four domains namely deficits in upper extremity strength, upper extremity proprioception, balance, and cognition. The total score consists of adding all four domains together along with 1.6. The total score can range from 1.6 to 6.8. The cutoff scores range from < 3.2 to > 5.2, where < 3.2 indicates a high likelihood of discharge home; a score between 3.2 and 5.2 respond better to inpatient rehabilitation; and a score of > 5.2 indicates increased risk of institutionalization as patients are typically dependent.
Measured: Baseline
Modified Rankin Scale (MRS)
The MRS is a global outcomes rating scale which ranges from 0 (no impairment) to 5 (severe disability- patient is bedridden, incontinent, and requires constant nursing care and attention) and 6 (death). A higher score indicates greater impairment.
Measured: Baseline
Functional Comorbidity Index (FCI)
The FCI was developed to assess comorbidity and used physical function as the outcome. It consists of an 18-item list of diagnoses. The scores range from 0 to 18 which is the cumulative sum of the comorbidities present.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Southeastern University
- Responsible party
- Principal investigator, Aniketh Chavan, New York Presbyterian Brooklyn Methodist Hospital
- Investigators
- Asad Siddiqi, DO, Principal investigator, New York Presbyterian Brooklyn Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139444
- Sponsor's protocol ID
- 2143128-1
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Physical Therapy Outcome Measures to Predict Discharge Destination in People With Stroke From Acute Care Hospital
- ClinicalTrials.gov ID
- NCT07139444
- Acronym / sponsor ID
- 2143128-1
- Conditions
- Stroke, Acute, Cerebrovascular Accident, Stroke, Stroke Hemorrhagic
- Keywords
- stroke, PASS, AM-PAC "6-Clicks", MSAS, acute care hospital, physical therapy outcome measures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- New York Presbyterian Brooklyn Methodist HospitalUniversity, hospital or other
- Collaborators
- Nova Southeastern University
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One time Physical Therapy EvaluationA 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. | Other | – |
Primary outcome
Mobility Scale for Acute Stroke (MSAS)
Time frame: Baseline
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.
Postural Assessment Scale for Stroke (PASS)
Time frame: Baseline
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.
Activity Measure for Post-Acute Care "6-Clicks" (AM-PAC "6-Clicks")
Time frame: Baseline
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.
3 secondary outcomes
Orpington Prognostic Scale (OPS)
Time frame: Baseline
Modified Rankin Scale (MRS)
Time frame: Baseline
Functional Comorbidity Index (FCI)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asad Siddiqi, DO principal investigator
New York Presbyterian Brooklyn Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Cerebrovascular Accident, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aniketh M Chavan, DPT (3176029203, dlx9003@nyp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility Scale for Acute Stroke (MSAS) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.