NCT06646939

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2025

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

October 2, 2024

Last Update Submit

February 24, 2026

Conditions

Keywords

Inpatient Rehabilitation UnitCommunity ReintegrationSimulated Environment

Outcome Measures

Primary Outcomes (1)

  • 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.

    Duration of IRU stay, an average of 11 days

Secondary Outcomes (9)

  • Quality Indicators

    Duration of IRU stay, an average of 11 days

  • Quality Indicators

    Duration of IRU stay, an average of 11 days

  • Quality Indicators

    Duration of IRU stay, an average of 11 days

  • Quality Indicators

    Duration of IRU stay, an average of 11 days

  • Gait Speed

    Duration of IRU stay, an average of 11 days

  • +4 more secondary outcomes

Study Arms (1)

Community Reintegration in Simulated Environment

EXPERIMENTAL
Behavioral: PT and OT with a simulated environment

Interventions

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.

Community Reintegration in Simulated Environment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NewYork Presbyterian Hospital Baker Pavilion

New York, New York, 10065, United States

Location

Related Publications (8)

  • 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.

    PMID: 9143432BACKGROUND
  • 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.

    PMID: 22796362BACKGROUND
  • 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.

    PMID: 11034230BACKGROUND
  • 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.

    PMID: 7814786BACKGROUND
  • 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.

    PMID: 22923430BACKGROUND
  • 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.

    PMID: 24812254BACKGROUND
  • 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.

    PMID: 28912076BACKGROUND
  • 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.

    PMID: 16323388BACKGROUND

Related Links

Study Officials

  • Nasim Chowdhury, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 17, 2024

Study Start

July 5, 2023

Primary Completion

December 9, 2025

Study Completion

December 9, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations