Comparison of Community Reintegration Interventions When Using a Simulated Environment

NCT ID: NCT06646939

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2026-10-01

Brief Summary

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The investigators believe that rehabilitation specialists will use community reintegration treatments more if a simulated environment is available.

Detailed Description

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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.

Conditions

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Simulated Environments for Community Reintegration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Community Reintegration in Simulated Environment

Group Type EXPERIMENTAL

PT and OT with a simulated environment

Intervention Type BEHAVIORAL

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.

Interventions

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PT and OT with a simulated environment

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hunter College of The City University of New York

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nasim Chowdhury, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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NewYork Presbyterian Hospital Baker Pavilion

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amy Meyer, DPT

Role: CONTACT

646-832-6431

Caitlin Burke, DPT

Role: CONTACT

Facility Contacts

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Delicia McCalla

Role: primary

212-746-1500

References

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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.

Reference Type BACKGROUND
PMID: 9143432 (View on PubMed)

Saliba 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.

Reference Type BACKGROUND
PMID: 22796362 (View on PubMed)

Richardson 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.

Reference Type BACKGROUND
PMID: 11034230 (View on PubMed)

Powell 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.

Reference Type BACKGROUND
PMID: 7814786 (View on PubMed)

Peel 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.

Reference Type BACKGROUND
PMID: 22923430 (View on PubMed)

Middleton 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.

Reference Type BACKGROUND
PMID: 24812254 (View on PubMed)

Karssemeijer 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.

Reference Type BACKGROUND
PMID: 28912076 (View on PubMed)

Eyssen 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.

Reference Type BACKGROUND
PMID: 16323388 (View on PubMed)

Related Links

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https://lermagazine.com/article/self-selected-gait-speed-a-critical-clinical-outcome=

Braden H. Self-selected gait speed: A Critical clinical outcome. Lower Extremity Review Magazine. November, 2012.

Other Identifiers

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22-07025042

Identifier Type: -

Identifier Source: org_study_id

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