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YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility (YOOMI)

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ClinicalTrials.gov Identifier: NCT05815017
Recruitment Status : Recruiting
First Posted : April 18, 2023
Last Update Posted : March 8, 2024
Sponsor:
Information provided by (Responsible Party):
Jay Naik MD, Rutgers, The State University of New Jersey

Study Description
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Brief Summary:
Patients admitted to the hospital often develop functional impairments due to being in bed most of the day. Each day of bedrest leads to significant muscle loss. As a result, many patients become dependent on others or require rehabilitation at a facility to improve mobility and function prior to returning home. Staff in the hospital is limited and often unable to mobilize patients every day while hospitalized. The investigators are testing a new experimental gamified physical therapy exercise software to see if it can be a fun, enjoyable way to help mobilize patients without the assistance of staff. The primary aim of this pilot/proof of concept study is to determine whether gamified physical therapy software can help inpatients exercise within the safety of their own beds and preserve pre-hospitalization function.

Condition or disease Intervention/treatment Phase
Weakness, Muscle Delirium in Old Age Muscle Atrophy or Weakness Muscle Loss Hospital Acquired Condition Physical Disability Physical Inactivity Device: Yoomi Physical Therapy Software Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility
Actual Study Start Date : November 29, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Gamified Physical Therapy Exercise Software Intervention + Usual Care
Participants randomized to the intervention group will be asked each day by a volunteer whether they would like to use the gamified physical therapy exercise software while in their beds. Participants willing to exercise will have the device set up for them to participate by a volunteer and the software will begin with a tutorial video for different exercises and then ask patients to perform in sequence with prompting and motion tracking. Exercises include Frontal Bicep Curls, Arm Crosses, Press Ups, Arm Rotations, and Basketball Shots.
 Device: Yoomi Physical Therapy Software
Physical Therapy software via a computer/monitor will be set up for the patient. It will begin with a tutorial video for different exercises in the form of games and then ask patients to perform in sequence with prompting and motion tracking. Exercises include Frontal Bicep Curls, Arm Crosses, Press Ups, Arm Rotations, and Basketball Shots.
No Intervention: Usual Care
Usual Care


Outcome Measures
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Primary Outcome Measures :
  1. Patient Satisfaction Score for Intervention Group Questionnaire (change is being assessed) [ Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks ]
  2. Software Utilization Time for Intervention Group (change is being assessed) [ Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks ]
  3. Percentage of exercise repetitions completed for Intervention Group (change is being assessed) [ Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks ]
    Completed exercises divided by assigned exercises by software


Secondary Outcome Measures :
  1. Patient Self-Assessments [ Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks ]
    Activity Measure for Post Acute Care (AMPAC) scores done as self-assessments (Score ranging from 0 to 24 with higher being better)

  2. 3DCAM Delirium Scale [ Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks ]
    22 questions including self reported and observations by staff to determine if patient has delirium

  3. Change in Activity Measure for Post Acute Care (AMPAC) Scores [ Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks ]
    Activity Measure for Post Acute Care (AMPAC) scores done by nurses twice daily (Score ranging from 0 to 24 with higher being better)

  4. Length of hospital stay [ Time Frame: Collected at the time of discharge of patient hospitalization, usually 1-2 weeks ]
  5. Post-discharge care needs [ Time Frame: Collected at time of discharge, usually 1-2 weeks ]
    Number of Partipants with Post-discharge needs e.g. subacute rehab, home PT, home assistance, acute rehab, etc

  6. Post-discharge Self Assessed Activity Measure for Post Acute Care (AMPAC) Score [ Time Frame: 30 days post-discharge ]
    AMPAC scores done as self-assessments (Score ranging from 0 to 24 with higher being better)


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • >= 65 years of age
  • English-fluency in reading and speaking
  • Capacity to consent
  • Enrolled in HELP program
  • Attending physician confirms there are no medical contraindications to in-bed exercises

Exclusion Criteria:

  • Unstable Psychiatric Illness
  • Unstable/Critically Ill Patients requiring ICU-level of care
  • Surgical tube present (e.g. JP drains)
  • Surgery during the hospitalization
  • Bed Rest Activity Order
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05815017


Contacts
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Contact: JAY NAIK, MD 732-235-7112 naikjh@rwjms.rutgers.edu

Locations
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United States, New Jersey
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Jay Naik, MD    732-235-7112    naikjh@rwjms.rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
More Information
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Responsible Party: Jay Naik MD, Assistant Professor of Medicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT05815017    
Other Study ID Numbers: Pro2022002225
First Posted: April 18, 2023    Key Record Dates
Last Update Posted: March 8, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jay Naik MD, Rutgers, The State University of New Jersey:
Artificial Intelligence (AI)
Physical Therapy
Hospitalization related muscle atrophy
 Hospitalization associated decline
Inpatient rehabilitation
AI driven physical therapy
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Atrophy
Atrophy
Asthenia
Iatrogenic Disease
Neurologic Manifestations
Nervous System Diseases
 Pathological Conditions, Anatomical
Neuromuscular Manifestations
Muscular Diseases
Musculoskeletal Diseases
Pathologic Processes
Disease Attributes