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

Primary Purpose

Weakness, Muscle, Delirium in Old Age, Muscle Atrophy or Weakness

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoomi Physical Therapy Software
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weakness, Muscle focused on measuring Artificial Intelligence (AI), Physical Therapy, Hospitalization related muscle atrophy, Hospitalization associated decline, Inpatient rehabilitation, AI driven physical therapy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Robert Wood Johnson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gamified Physical Therapy Exercise Software Intervention + Usual Care

Usual Care

Arm Description

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.

Usual Care

Outcomes

Primary Outcome Measures

Patient Satisfaction Score for Intervention Group Questionnaire (change is being assessed)
Software Utilization Time for Intervention Group (change is being assessed)
Percentage of exercise repetitions completed for Intervention Group (change is being assessed)
Completed exercises divided by assigned exercises by software

Secondary Outcome Measures

Patient Self-Assessments
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
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
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
Post-discharge care needs
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
AMPAC scores done as self-assessments (Score ranging from 0 to 24 with higher being better)

Full Information

First Posted
March 8, 2023
Last Updated
August 15, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT05815017
Brief Title
YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility
Acronym
YOOMI
Official Title
YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weakness, Muscle, Delirium in Old Age, Muscle Atrophy or Weakness, Muscle Loss, Hospital Acquired Condition, Physical Disability, Physical Inactivity
Keywords
Artificial Intelligence (AI), Physical Therapy, Hospitalization related muscle atrophy, Hospitalization associated decline, Inpatient rehabilitation, AI driven physical therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gamified Physical Therapy Exercise Software Intervention + Usual Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Device
Intervention Name(s)
Yoomi Physical Therapy Software
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Satisfaction Score for Intervention Group Questionnaire (change is being assessed)
Time Frame
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Title
Software Utilization Time for Intervention Group (change is being assessed)
Time Frame
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Title
Percentage of exercise repetitions completed for Intervention Group (change is being assessed)
Description
Completed exercises divided by assigned exercises by software
Time Frame
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Secondary Outcome Measure Information:
Title
Patient Self-Assessments
Description
Activity Measure for Post Acute Care (AMPAC) scores done as self-assessments (Score ranging from 0 to 24 with higher being better)
Time Frame
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Title
3DCAM Delirium Scale
Description
22 questions including self reported and observations by staff to determine if patient has delirium
Time Frame
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Title
Change in Activity Measure for Post Acute Care (AMPAC) Scores
Description
Activity Measure for Post Acute Care (AMPAC) scores done by nurses twice daily (Score ranging from 0 to 24 with higher being better)
Time Frame
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Title
Length of hospital stay
Time Frame
Collected at the time of discharge of patient hospitalization, usually 1-2 weeks
Title
Post-discharge care needs
Description
Number of Partipants with Post-discharge needs e.g. subacute rehab, home PT, home assistance, acute rehab, etc
Time Frame
Collected at time of discharge, usually 1-2 weeks
Title
Post-discharge Self Assessed Activity Measure for Post Acute Care (AMPAC) Score
Description
AMPAC scores done as self-assessments (Score ranging from 0 to 24 with higher being better)
Time Frame
30 days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JAY NAIK, MD
Phone
732-235-7112
Email
naikjh@rwjms.rutgers.edu
Facility Information:
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Naik, MD
Phone
732-235-7112
Email
naikjh@rwjms.rutgers.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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