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

NCT05815017 | Recruiting FDA Device

• 1 other identifier: Pro2022002225
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• Patient Self-Assessments

  Collected daily throughout duration of patient hospitalization, usually 1-2 weeks

• 3DCAM Delirium Scale

  Collected daily throughout duration of patient hospitalization, usually 1-2 weeks

• Change in Activity Measure for Post Acute Care (AMPAC) Scores

  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

  Collected at time of discharge, usually 1-2 weeks

Study Arms (2)

Gamified Physical Therapy Exercise Software Intervention + Usual Care

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Usual Care

Interventions

Yoomi Physical Therapy Software DEVICE

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.

Gamified Physical Therapy Exercise Software Intervention + Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Muscle Weakness; Muscular Atrophy; Asthenia; Iatrogenic Disease; Sedentary Behavior

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Atrophy; Pathological Conditions, Anatomical; Disease Attributes; Behavior

Central Study Contacts

JAY NAIK, MD

CONTACT

732-235-7112; naikjh@rwjms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 18, 2023
• Study Start: November 29, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)