- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05815017
YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility (YOOMI)
March 6, 2024 updated by: Jay Naik MD, Rutgers, The State University of New Jersey
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jay Naik, MD
- Phone Number: 732-235-7112
- Email: naikjh@rwjms.rutgers.edu
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Robert Wood Johnson University Hospital
-
Contact:
- Jay Naik, MD
- Phone Number: 732-235-7112
- Email: naikjh@rwjms.rutgers.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction Score for Intervention Group Questionnaire (change is being assessed)
Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
|
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
|
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
|
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
|
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
|
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
|
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)
|
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
|
Length of hospital stay
Time Frame: Collected at the time of discharge of patient hospitalization, usually 1-2 weeks
|
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
|
Collected at time of discharge, usually 1-2 weeks
|
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)
|
30 days post-discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
March 8, 2023
First Submitted That Met QC Criteria
April 3, 2023
First Posted (Actual)
April 18, 2023
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2022002225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Disability
-
University of Alabama at BirminghamRecruitingDisability Physical | Physical InactivityUnited States
-
Assistance Publique - Hôpitaux de ParisTerminatedPhysical Activity | Physical DisabilityFrance
-
Istanbul Medeniyet UniversityRecruitingPhysical DisabilityTurkey
-
State University of New York - Upstate Medical...Completed
-
Permobil, Inc.Completed
-
University of PittsburghPatient-Centered Outcomes Research InstituteCompletedPhysical DisabilityUnited States
-
Washington University School of MedicineRecruitingPhysical DisabilityUnited States
-
Stanford UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
University of Alabama at BirminghamRecruiting
-
Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingDisability PhysicalUnited States
Clinical Trials on Yoomi Physical Therapy Software
-
Engy Badreldin Saleh Moustafa, PhDRecruiting
-
Universidade Federal de Santa MariaCompleted
-
Riphah International UniversityCompleted
-
Centre Hospitalier St AnneCompleted
-
Mayo ClinicDePuy OrthopaedicsCompleted
-
Second Affiliated Hospital, School of Medicine,...Recruiting
-
International Hellenic UniversityNot yet recruitingChronic Pain | Neuropathic Pain | Cognitive Therapy
-
Universidad de ZaragozaCompletedPlagiocephaly | Plagiocephaly, Nonsynostotic | Plagiocephaly, PositionalSpain
-
Experiad LLCnorthwest behavioral associatesUnknownAutism Spectrum DisorderUnited States