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

NCT06222554 | Completed FDA Device

• 1 other identifier: 23-01384
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplant; Liver Transplant

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

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

  Baseline, End of Hospital Stay (typically no more than 6 months post-operation)

• Change in Grip Strength

  Baseline, End of Hospital Stay (typically no more than 6 months post-operation)

• Upper Extremity Range of Motion (ROM) Change

  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

  Baseline, End of Hospital Stay (typically no more than 6 months post-operation)

Study Arms (1)

Patients Hospitalized following Kidney or Liver Transplant

EXPERIMENTAL

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

Interventions

MoveMend Health DEVICE

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.

Patients Hospitalized following Kidney or Liver Transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• John Corcoran

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 24, 2024
• Study Start: August 6, 2024
• Primary Completion: November 24, 2024
• Study Completion: November 27, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (1)