Examining the Use of a Novel Immersive Motion Tracking Upper Extremity Exercise Program for Acute Hospitalized Patients

Pilot/Feasibility Study Examining the Use of a Novel Immersive Motion Tracking Upper Extremity Exercise Program for Acute Hospitalized Patients

The objective of this study is to evaluate the feasibility of the MoveMend Health software program as an integrated supplement to traditional acute care/in-hospital occupational therapy for patients following liver and kidney transplants, as determined by recruitment rates, program completion, intervention adherence, safety incidence, and patient feedback on device/program performance.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplant; Kidney Transplant
• Intervention / Treatment: Device: MoveMend Health

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabrielle Berne; Phone Number: (914) 960-5355; Email: Gabrielle.berne@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English speaking (software program is currently only available in English)
• Status post kidney or liver transplant this admission
• Physician orders for occupational therapy evaluation and treatment
• Orientation Log > 25
• Negative for delirium per the Confusion Assessment Method

Exclusion Criteria:

• Orthopedic or surgical precautions that limits shoulder range of motion beyond 90 degrees
• Upper extremity hemiplegia with inability to lift upper extremity against gravity
• Accommodation code of Intensive Care Unit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients Hospitalized following Kidney or Liver Transplant; Patients in the study will be introduced to the exercise software program and provided with a demonstration. Measurements will be taken at baseline (post-operation) and at the final study visit. Participants will remain in the study until the end of their hospital stay, typically no longer than 6 months post-operation.	Device: MoveMend Health; Software-based therapeutic tool that offers gamified exercises and activities. The device is designed for deployment on tablets. The core purpose of the device is to augment patient engagement and participation in their own rehabilitation by providing additional therapeutic interventions between formal occupational therapy sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	Calculated by dividing the number of participants enrolled by the total number of patients contacted or screened.	Up to Month 6 Post-Operation
Percentage of Participants who Complete Exercise Program	Percentage of enrolled participants who complete the interventional program.	Up to Month 6 Post-Operation
Percentage of Participants who Adhere to Intervention	Measured by session duration and frequency, as recorded by the device. Participants will be classified as "adhering" or "not adhering."	Up to Month 6 Post-Operation
Number of Adverse Events	Measured using data from participant's electronic medical record.	Up to Month 6 Post-Operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Activity Measure for Post-Acute Care (AMPAC) Score	12-item assessment of basic mobility of inpatients. Each item is rated on a Likert scale from 1-4. The raw score is the sum of responses, which is converted to a T-score. The total score is a T-score ranging from 0 to 100; higher scores indicate greater mobility.	Baseline, End of Hospital Stay (typically no more than 6 months post-operation)
Change in Grip Strength	Measured as the percentage change in grip strength between the baseline assessment and the final assessment at discharge.	Baseline, End of Hospital Stay (typically no more than 6 months post-operation)
Upper Extremity Range of Motion (ROM) Change	Measured as the change in degrees of ROM at the shoulder and elbow as measured by a goniometer from baseline to discharge.	Baseline, End of Hospital Stay (typically no more than 6 months post-operation)
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score	The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction.	Baseline, End of Hospital Stay (typically no more than 6 months post-operation)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Steve Vanlew, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 17, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 23-01384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Gabrielle Berne, Gabrielle.berne@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Gabrielle.berne@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

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