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Clinical Trial NCT05815017 (YOOMI) for Weakness, Muscle, Delirium in Old Age, Muscle Atrophy or Weakness, Muscle Loss, Hospital Acquired Condition, Physical Disability, Physical Inactivity is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility
Clinical Trial NCT05815017 (YOOMI) is an interventional study for Weakness, Muscle, Delirium in Old Age, Muscle Atrophy or Weakness, Muscle Loss, Hospital Acquired Condition, Physical Disability, Physical Inactivity that is recruiting. It started on November 29, 2023 with plans to enroll 80 participants. Led by Rutgers, The State University of New Jersey, it is expected to complete by December 1, 2024. The latest data from ClinicalTrials.gov was last updated on March 8, 2024.
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.
Official Title
YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility
Conditions
Weakness, MuscleDelirium in Old AgeMuscle Atrophy or WeaknessMuscle LossHospital Acquired ConditionPhysical DisabilityPhysical InactivityOther Study IDs
- YOOMI
- Pro2022002225
NCT ID Number
Start Date (Actual)
2023-11-29
Last Update Posted
2024-03-08
Completion Date (Estimated)
2024-12
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Artificial Intelligence (AI)
Physical Therapy
Hospitalization related muscle atrophy
Hospitalization associated decline
Inpatient rehabilitation
AI driven physical therapy
Physical Therapy
Hospitalization related muscle atrophy
Hospitalization associated decline
Inpatient rehabilitation
AI driven physical therapy
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalGamified 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. | 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 InterventionUsual Care Usual Care | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Patient Satisfaction Score for Intervention Group Questionnaire (change is being assessed) | Collected daily throughout duration of patient hospitalization, usually 1-2 weeks | |
Software Utilization Time for Intervention Group (change is being assessed) | Collected daily throughout duration of patient hospitalization, usually 1-2 weeks | |
Percentage of exercise repetitions completed for Intervention Group (change is being assessed) | Completed exercises divided by assigned exercises by software | Collected daily throughout duration of patient hospitalization, usually 1-2 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | Collected daily throughout duration of patient hospitalization, usually 1-2 weeks |
3DCAM Delirium Scale | 22 questions including self reported and observations by staff to determine if patient has delirium | Collected daily throughout duration of patient hospitalization, usually 1-2 weeks |
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) | Collected daily throughout duration of patient hospitalization, usually 1-2 weeks |
Length of hospital stay | Collected at the time of discharge of patient hospitalization, usually 1-2 weeks | |
Post-discharge care needs | Number of Partipants with Post-discharge needs e.g. subacute rehab, home PT, home assistance, acute rehab, etc | Collected at time of discharge, usually 1-2 weeks |
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) | 30 days post-discharge |
Eligibility Criteria
Eligible Ages
Older Adult
Minimum Age
65 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- >= 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
- 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
Rutgers, The State University of New JerseyStudy Responsible Party
Jay Naik MD, Principal Investigator, Assistant Professor of Medicine, Rutgers, The State University of New Jersey
Study Central Contact
Contact: JAY NAIK, MD, 732-235-7112, [email protected]
1 Study Locations in 1 Countries
New Jersey
Robert Wood Johnson University Hospital, New Brunswick, New Jersey, 08901, United States
Jay Naik, MD, Contact, 732-235-7112, [email protected]
Recruiting