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Completed

NCT Number: NCT06222554

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment Rate

    Time frame: Up to Month 6 Post-Operation

    Calculated by dividing the number of participants enrolled by the total number of patients contacted or screened.

  2. Percentage of Participants who Complete Exercise Program

    Time frame: Up to Month 6 Post-Operation

    Percentage of enrolled participants who complete the interventional program.

  3. Percentage of Participants who Adhere to Intervention

    Time frame: Up to Month 6 Post-Operation

    Measured by session duration and frequency, as recorded by the device. Participants will be classified as "adhering" or "not adhering."

  4. Number of Adverse Events

    Time frame: Up to Month 6 Post-Operation

    Measured using data from participant's electronic medical record.

Secondary outcomes

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

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

    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.

  2. Change in Grip Strength

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

    Measured as the percentage change in grip strength between the baseline assessment and the final assessment at discharge.

  3. Upper Extremity Range of Motion (ROM) Change

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

    Measured as the change in degrees of ROM at the shoulder and elbow as measured by a goniometer from baseline to discharge.

  4. Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score

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

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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