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

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

Tracking Information

• First Submitted Date: March 8, 2023
• First Posted Date: April 18, 2023
• Last Update Posted Date: March 8, 2024
• Actual Study Start Date: November 29, 2023
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 3, 2023)

• Patient Satisfaction Score for Intervention Group Questionnaire (change is being assessed) [ Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks ]
• Software Utilization Time for Intervention Group (change is being assessed) [ Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks ]
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 3, 2023)

• 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)
• 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
• 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)
• Length of hospital stay [ Time Frame: Collected at the time of discharge of patient hospitalization, usually 1-2 weeks ]
• 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
• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility
• Official Title: YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Weakness, Muscle
• Delirium in Old Age
• Muscle Atrophy or Weakness
• Muscle Loss
• Hospital Acquired Condition
• Physical Disability
• Physical Inactivity

Intervention

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.

Study Arms

• 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.
  Intervention: Device: Yoomi Physical Therapy Software
• No Intervention: Usual Care
  Usual Care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 3, 2023): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05815017
• Other Study ID Numbers: Pro2022002225
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jay Naik MD, Rutgers, The State University of New Jersey
• Original Responsible Party: Same as current
• Current Study Sponsor: Rutgers, The State University of New Jersey
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Rutgers, The State University of New Jersey
• Verification Date: March 2024