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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05815017
Other study ID # Pro2022002225
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 29, 2023
Est. completion date December 2024

Study information

Verified date March 2024
Source Rutgers, The State University of New Jersey
Contact JAY NAIK, MD
Phone 732-235-7112
Email naikjh@rwjms.rutgers.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


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.

Locations

Country Name City State
United States Robert Wood Johnson University Hospital New Brunswick New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Satisfaction Score for Intervention Group Questionnaire (change is being assessed) Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Primary Software Utilization Time for Intervention Group (change is being assessed) Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Primary 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 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
Secondary 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
Secondary 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
Secondary Length of hospital stay Collected at the time of discharge of patient hospitalization, usually 1-2 weeks
Secondary 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
Secondary 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
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