Digitalization of Measuring Physical Performance

NCT06564350 | Completed FDA Device

• 1 other identifier: 2000034742
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators will test the validity and reproducibility of the measurement of motor performance using wearables and the correlation of this measurement with function and mobility.

Conditions

Physical Performance

Outcome Measures

Primary Outcomes (1)

• Digitalized scores of physical performance

  A percentage score, which determines how well a participant can do motor tasks for strength, balance, mobility, range of motion and tasks of activities of daily life. Computer software will be used to evaluate the test score of the patient using information from the wearable sensors. The resulting score will be evaluated with the help of a Regression Machine Learning Algorithm. These results will be compared to the assessment and scoring of physical performance by rehabilitation therapists that is based on observation. Higher percentage indicates better performance.

  up to 5 weeks

Study Arms (1)

Modified Physical Performance test (MPPT)

Participants will perform MPPT with and without the wearable seonsors.

Device: IMU (Inertial Measurement Unit) sensors

Interventions

IMU (Inertial Measurement Unit) sensors DEVICE

IMU sensors track an object's acceleration and angular velocity over time and do not emit any electromagnetic fields or radiation. They use tiny masses and springs to measure the acceleration, as well as Hall effect materials to measure the magnetic fields. The force sensor changes its electric resistor value based on the force applied to the sensor surface.

Modified Physical Performance test (MPPT)

Eligibility Criteria

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

Study Population

Participants are patients admitted to acute inpatient rehabilitation unit for rehabilitation who are able to stand and walk with or without an assistive device.

You may qualify if:

• Participants can stand with or without an assistive device with or without assistance form another person/s
• Participants can walk with or without an assistive device with or without assistance from another person/s
• Participants are able to memorize easy tasks, and able to follow instructions e.g., standing up or walking until a certain location in the room

You may not qualify if:

• Participants who are not cleared physically or medically to participate in standard acute inpatient rehabilitation therapies by the rehabilitation physician
• Not able to memorize easy tasks, e.g., standing up or walking until a certain location in the room
• One or more leg/feet amputated

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital Rehabilitation and Wellness center

New Haven, Connecticut, 06520, United States

Location

Study Officials

• Rummana Aslam, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: July 27, 2023
• Primary Completion: August 4, 2023
• Study Completion: August 11, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

US (1)