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

Kidney Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06222554
• Other study ID #: 23-01384
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Gabrielle Berne
• Phone: (914) 960-5355
• Email: Gabrielle.berne[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 1, 2024
• Est. primary completion date: April 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant
• Liver Transplant

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of Participants who Complete Exercise Program	Percentage of enrolled participants who complete the interventional program.	Up to Month 6 Post-Operation
Primary	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
Primary	Number of Adverse Events	Measured using data from participant's electronic medical record.	Up to Month 6 Post-Operation
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)