Kidney TransplantNCT06222554
Examining the Use of a Novel Immersive Motion Tracking Upper Extremity Exercise Program for Acute Hospitalized Patients
A study testing MoveMend Health in people with Kidney Transplant and Liver Transplant, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Liver Transplant
- What is being tested?
- MoveMend Health
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2024to 27 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Kidney Transplant, Liver Transplant
- Being tested
- MoveMend Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoveMend HealthDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MoveMend Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Calculated by dividing the number of participants enrolled by the total number of patients contacted or screened.
Measured: Up to Month 6 Post-Operation
Percentage of Participants who Complete Exercise Program
Percentage of enrolled participants who complete the interventional program.
Measured: 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."
Measured: Up to Month 6 Post-Operation
Number of Adverse Events
Measured using data from participant's electronic medical record.
Measured: Up to Month 6 Post-Operation
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, End of Hospital Stay (typically no more than 6 months post-operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start6 Aug 2024
- Primary completion24 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Corcoran, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222554
- Sponsor's protocol ID
- 23-01384
- Status last verified
- Apr 2025
- First submitted
- 16 Jan 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot/Feasibility Study Examining the Use of a Novel Immersive Motion Tracking Upper Extremity Exercise Program for Acute Hospitalized Patients
- ClinicalTrials.gov ID
- NCT06222554
- Acronym / sponsor ID
- 23-01384
- Conditions
- Kidney Transplant, Liver Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Hospitalized following Kidney or Liver Transplant | Experimental | Device: MoveMend HealthPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoveMend HealthSoftware-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. | Device | Patients Hospitalized following Kidney or Liver Transplant |
Primary outcome
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.
Percentage of Participants who Complete Exercise Program
Time frame: Up to Month 6 Post-Operation
Percentage of enrolled participants who complete the interventional program.
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."
Number of Adverse Events
Time frame: Up to Month 6 Post-Operation
Measured using data from participant's electronic medical record.
4 secondary outcomes
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)
Change in Grip Strength
Time frame: Baseline, End of Hospital Stay (typically no more than 6 months post-operation)
Upper Extremity Range of Motion (ROM) Change
Time frame: 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
Time frame: Baseline, End of Hospital Stay (typically no more than 6 months post-operation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Corcoran principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoveMend Health in people with Kidney Transplant and Liver Transplant, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Up to Month 6 Post-Operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.