Simulated Environments for Community ReintegrationNCT06646939
Comparison of Community Reintegration Interventions When Using a Simulated Environment
A study testing PT and OT with a simulated environment in people with Simulated Environments for Community Reintegration, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The investigators believe that rehabilitation specialists will use community reintegration treatments more if a simulated environment is available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Simulated Environments for Community Reintegration
- What is being tested?
- PT and OT with a simulated environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2023to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical records of patients admitted to the IRU from January 1, 2015 through December 31, 2019 will be queried for number of minutes billed for Community Integration.
- Medical records of patients admitted to the IRU from April 2
- Patients admitted to the Inpatient Rehabilitation Unit (IRU) of at least 18 years of age and older
- Patients who can read and provide informed consent in English.
- Patients who will be discharged to home after inpatient rehabilitation.
- Patients who are ambulatory with a minimal QI score of 3 on "Walk 10 feet".
- Patients who utilized the simulated environment during their inpatient stay.
- Patients who score 8 or greater on the BIMS on initial evaluation.
Who cannot join
- The investigators will exclude medical records of patients admitted to the IRU from January 1, 2020 through December 31, 2021 because of the COVID restrictions that were in place.
- Patients who are less than 18 years of age.
- Patients who are not ambulatory due to medical reasons.
- Patients who cannot read and provide informed consent in English.
- Patients who were discharged to acute care, skilled nursing facility or long-term care facility after their inpatient rehabilitation stay.
- Patients who did not use the simulated environment during their inpatient stay.
- Patients who score 7 or lower on the BIMS on initial evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork Presbyterian Hospital Baker Pavilion
New York, New York, 10065
About this study
Official title: Comparison of Community Reintegration Interventions Relative to the Institution of a Simulated Environment in Inpatient Rehabilitation and Pilot Study of the Impact of Simulated Environment on Functional Outcomes
The investigators believe that rehabilitation specialists will use community reintegration treatments more if a simulated environment is available.
Read the detailed description
Community reintegration training has always been a significant aspect of inpatient rehabilitation recovery. Community reintegration training involved therapists and patients going into the actual community to evaluate and practice their functional tasks such as negotiating curbs, crosswalks, or marketplaces. During the COVID-19 pandemic, this option was not available. The absence of this intervention made it challenging for therapists to evaluate a patient's safety to return home. Creating a simulated environment within the inpatient rehabilitation department became an alternative to taking patients to an outside environment. Saji, et al. (2015) demonstrated that utilization of a simulated environment enhanced functional improvements of post-acute stroke patients at 12 convalescent rehabilitation wards. New York Presbyterian Weill Cornell Medical Center (NYP- WCMC) has constructed a simulated environment for the purposes of enhancing community reintegration training. This project will test its use and efficacy.
The availability of this simulated environment may be more time-efficient and safer than community reintegration training outside of the department or hospital. Training in the simulated environment may improve the functional ability of individuals undergoing inpatient rehabilitation, in accordance with the degree of use of the simulated environment. Greater use of the simulated environment may predict greater functional improvements. This study will collect pilot data about functional outcomes and patient perspectives about their balance confidence, their ability to perform functional tasks, and the efficacy of the use of simulated environment for community reintegration. This pilot data will seed a future efficacy study with a comparison group.
- Being tested
- PT and OT with a simulated environment
- Keywords
- Inpatient Rehabilitation Unit, Community Reintegration, Simulated Environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT and OT with a simulated environmentBehavioural
Upon admission to the inpatient rehabilitation unit, participants will undergo a physical and occupational therapy evaluation. The evaluations will include the outcome measures chosen to track for this study (10-meter walk test and Quality Indicators). If a patient meets inclusion/exclusion criteria, informed written consent will be obtained. Throughout the patient's stay, therapists will have the opportunity to perform community integration treatments using the simulated environment. This could include activities such as negotiating a curb, crossing a street, or shopping at a marketplace. The therapist will document the amount of time (units billed) spent performing these interventions. The research investigators will not act as a patient's therapist throughout their admission.
| Study group | Role | What they receive |
|---|---|---|
| Community Reintegration in Simulated Environment | Experimental | Not described Receives: Behavioral: PT and OT with a simulated environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of community reintegration, as measured by number of 15-minute units billed
Current Procedural Terminology (CPT) code 9753, is a billing code where one unit of the code is used for each 15 minutes the provider spends with the patient teaching them return to work and the community.
For this measure, the therapist will document the amount of time spent performing each study activity when utilizing the simulated environment, as measured by number of 15-minute units billed..
This will be compared to units billed in 2015 - 2019 prior to the implementation of the simulated environment for this study.
Measured: Duration of IRU stay, an average of 11 days
Secondary outcomes (9)
Quality Indicators
Qualitative assessment by the therapist of 1 step onto and off a curb
Measured: Duration of IRU stay, an average of 11 days
Quality Indicators
Qualitative assessment by the therapist of picking up an object
Measured: Duration of IRU stay, an average of 11 days
Quality Indicators
Qualitative assessment by the therapist of walking 10 feet on uneven surface
Measured: Duration of IRU stay, an average of 11 days
Quality Indicators
Qualitative assessment by the therapist of car transfer
Measured: Duration of IRU stay, an average of 11 days
Gait Speed
Meters/second
Measured: Duration of IRU stay, an average of 11 days
Activities Specific Balance Confidence Scale
The Activities-specific Balance Confidence (ABC) scale is scored by adding up the ratings for each item and dividing by 16, the total number of items.
The scale uses a range of 0-100%, with 0 representing no confidence and 100 representing complete confidence.
The resulting score indicates the participant's overall balance confidence. 80% or higher: The participant has a high level of physical functioning and is at low risk for falls 50-80%: The participant has a moderate level of physical functioning Less than 50%: The participant has a low level of physical functioning and is at a high risk of falling Less than 67%: The participant has a substantial risk of falling
Measured: Duration of IRU stay, an average of 11 days
Patient satisfaction
Likert scale, with a low score of 1 and a high score of 5.
Measured: Date of Discharge (at approximately Day 11)
Patient satisfaction
Likert scale, with a low score of 1 and a high score of 5.
Measured: 30 days post discharge
Length of Stay
Days
Measured: Duration of IRU stay, an average of 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start5 Jul 2023
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Simulated Environments for Community ReintegrationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Hunter College of The City University of New York
- Responsible party
- Sponsor
- Investigators
- Nasim Chowdhury, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646939
- Sponsor's protocol ID
- 22-07025042
- Status last verified
- Feb 2026
- First submitted
- 2 Oct 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bohannon RW. Comfortable and maximum walking speed of adults aged 20-79 years: reference values and determinants. Age Ageing. 1997 Jan;26(1):15-9. doi: 10.1093/ageing/26.1.15.
PubMed 9143432Saliba D, Buchanan J, Edelen MO, Streim J, Ouslander J, Berlowitz D, Chodosh J. MDS 3.0: brief interview for mental status. J Am Med Dir Assoc. 2012 Sep;13(7):611-7. doi: 10.1016/j.jamda.2012.06.004. Epub 2012 Jul 15.
PubMed 22796362Richardson J, Law M, Wishart L, Guyatt G. The use of a simulated environment (easy street) to retrain independent living skills in elderly persons: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2000 Oct;55(10):M578-84. doi: 10.1093/gerona/55.10.m578.
PubMed 11034230Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
PubMed 7814786Peel NM, Kuys SS, Klein K. Gait speed as a measure in geriatric assessment in clinical settings: a systematic review. J Gerontol A Biol Sci Med Sci. 2013 Jan;68(1):39-46. doi: 10.1093/gerona/gls174. Epub 2012 Aug 24.
PubMed 22923430Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.
PubMed 24812254Karssemeijer EGA, Aaronson JA, Bossers WJ, Smits T, Olde Rikkert MGM, Kessels RPC. Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Ageing Res Rev. 2017 Nov;40:75-83. doi: 10.1016/j.arr.2017.09.003. Epub 2017 Sep 12.
PubMed 28912076Eyssen IC, Beelen A, Dedding C, Cardol M, Dekker J. The reproducibility of the Canadian Occupational Performance Measure. Clin Rehabil. 2005 Dec;19(8):888-94. doi: 10.1191/0269215505cr883oa.
PubMed 16323388
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Community Reintegration Interventions Relative to the Institution of a Simulated Environment in Inpatient Rehabilitation and Pilot Study of the Impact of Simulated Environment on Functional Outcomes
- ClinicalTrials.gov ID
- NCT06646939
- Acronym / sponsor ID
- 22-07025042
- Keywords
- Inpatient Rehabilitation Unit, Community Reintegration, Simulated Environment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Hunter College of The City University of New York
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 17 Oct 2024 (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.
The investigators believe that rehabilitation specialists will use community reintegration treatments more if a simulated environment is available.
Detailed description
Community reintegration training has always been a significant aspect of inpatient rehabilitation recovery. Community reintegration training involved therapists and patients going into the actual community to evaluate and practice their functional tasks such as negotiating curbs, crosswalks, or marketplaces. During the COVID-19 pandemic, this option was not available. The absence of this intervention made it challenging for therapists to evaluate a patient's safety to return home. Creating a simulated environment within the inpatient rehabilitation department became an alternative to taking patients to an outside environment. Saji, et al. (2015) demonstrated that utilization of a simulated environment enhanced functional improvements of post-acute stroke patients at 12 convalescent rehabilitation wards. New York Presbyterian Weill Cornell Medical Center (NYP- WCMC) has constructed a simulated environment for the purposes of enhancing community reintegration training. This project will test its use and efficacy.
The availability of this simulated environment may be more time-efficient and safer than community reintegration training outside of the department or hospital. Training in the simulated environment may improve the functional ability of individuals undergoing inpatient rehabilitation, in accordance with the degree of use of the simulated environment. Greater use of the simulated environment may predict greater functional improvements. This study will collect pilot data about functional outcomes and patient perspectives about their balance confidence, their ability to perform functional tasks, and the efficacy of the use of simulated environment for community reintegration. This pilot data will seed a future efficacy study with a comparison group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community Reintegration in Simulated Environment | Experimental | Behavioral: PT and OT with a simulated environment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Medical records of patients admitted to the IRU from January 1, 2015 through December 31, 2019 will be queried for number of minutes billed for Community Integration.
- Medical records of patients admitted to the IRU from April 2
- Patients admitted to the Inpatient Rehabilitation Unit (IRU) of at least 18 years of age and older
- Patients who can read and provide informed consent in English.
- Patients who will be discharged to home after inpatient rehabilitation.
Key exclusion criteria (7 listed)
- The investigators will exclude medical records of patients admitted to the IRU from January 1, 2020 through December 31, 2021 because of the COVID restrictions that were in place.
- Patients who are less than 18 years of age.
- Patients who are not ambulatory due to medical reasons.
- Patients who cannot read and provide informed consent in English.
- Patients who were discharged to acute care, skilled nursing facility or long-term care facility after their inpatient rehabilitation stay.
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 |
|---|---|---|
| PT and OT with a simulated environmentUpon admission to the inpatient rehabilitation unit, participants will undergo a physical and occupational therapy evaluation. The evaluations will include the outcome measures chosen to track for this study (10-meter walk test and Quality Indicators). If a patient meets inclusion/exclusion criteria, informed written consent will be obtained. Throughout the patient's stay, therapists will have the opportunity to perform community integration treatments using the simulated environment. This could include activities such as negotiating a curb, crossing a street, or shopping at a marketplace. The therapist will document the amount of time (units billed) spent performing these interventions. The research investigators will not act as a patient's therapist throughout their admission. | Behavioural | Community Reintegration in Simulated Environment |
Primary outcome
Utilization of community reintegration, as measured by number of 15-minute units billed
Time frame: Duration of IRU stay, an average of 11 days
Current Procedural Terminology (CPT) code 9753, is a billing code where one unit of the code is used for each 15 minutes the provider spends with the patient teaching them return to work and the community. For this measure, the therapist will document the amount of time spent performing each study activity when utilizing the simulated environment, as measured by number of 15-minute units billed.. This will be compared to units billed in 2015 - 2019 prior to the implementation of the simulated environment for this study.
9 secondary outcomes
Quality Indicators
Time frame: Duration of IRU stay, an average of 11 days
Quality Indicators
Time frame: Duration of IRU stay, an average of 11 days
Quality Indicators
Time frame: Duration of IRU stay, an average of 11 days
Quality Indicators
Time frame: Duration of IRU stay, an average of 11 days
Gait Speed
Time frame: Duration of IRU stay, an average of 11 days
Activities Specific Balance Confidence Scale
Time frame: Duration of IRU stay, an average of 11 days
Patient satisfaction
Time frame: Date of Discharge (at approximately Day 11)
Patient satisfaction
Time frame: 30 days post discharge
Length of Stay
Time frame: Duration of IRU stay, an average of 11 days
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 9143432Bohannon RW. Comfortable and maximum walking speed of adults aged 20-79 years: reference values and determinants. Age Ageing. 1997 Jan;26(1):15-9. doi: 10.1093/ageing/26.1.15.
- Background: PubMed 22796362Saliba D, Buchanan J, Edelen MO, Streim J, Ouslander J, Berlowitz D, Chodosh J. MDS 3.0: brief interview for mental status. J Am Med Dir Assoc. 2012 Sep;13(7):611-7. doi: 10.1016/j.jamda.2012.06.004. Epub 2012 Jul 15.
- Background: PubMed 11034230Richardson J, Law M, Wishart L, Guyatt G. The use of a simulated environment (easy street) to retrain independent living skills in elderly persons: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2000 Oct;55(10):M578-84. doi: 10.1093/gerona/55.10.m578.
- Background: PubMed 7814786Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
- Background: PubMed 22923430Peel NM, Kuys SS, Klein K. Gait speed as a measure in geriatric assessment in clinical settings: a systematic review. J Gerontol A Biol Sci Med Sci. 2013 Jan;68(1):39-46. doi: 10.1093/gerona/gls174. Epub 2012 Aug 24.
- Background: PubMed 24812254Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.
- Background: PubMed 28912076Karssemeijer EGA, Aaronson JA, Bossers WJ, Smits T, Olde Rikkert MGM, Kessels RPC. Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Ageing Res Rev. 2017 Nov;40:75-83. doi: 10.1016/j.arr.2017.09.003. Epub 2017 Sep 12.
- Background: PubMed 16323388Eyssen IC, Beelen A, Dedding C, Cardol M, Dekker J. The reproducibility of the Canadian Occupational Performance Measure. Clin Rehabil. 2005 Dec;19(8):888-94. doi: 10.1191/0269215505cr883oa.
- Braden H. Self-selected gait speed: A Critical clinical outcome. Lower Extremity Review Magazine. November, 2012.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Nasim Chowdhury, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PT and OT with a simulated environment in people with Simulated Environments for Community Reintegration, run by Weill Medical College of Cornell University 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 25 Feb 2026. 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?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization of community reintegration, as measured by number of 15-minute units billed (time frame: Duration of IRU stay, an average of 11 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06646939, which also lists 8 linked publications.
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 25 Feb 2026.