Digitalization of Measuring Physical Performance

NCT ID: NCT06564350

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-27
• Study Completion Date: 2023-08-11

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.

Detailed Description

The primary objective of this study is to determine whether the digital measurement of physical performance delivers more accurate and more consistent results than the current traditional measurement of physical performance done by rehabilitation therapists in the rehabilitation patient population.

The primary outcome of this study is to check the correlation between the traditional rehabilitation test scores of Modified Physical Performance test (MPPT), and measured values via the wearables.

The MPPT consists of sub-tasks, which are part of standard physical and occupational therapy evaluation and treatment in the inpatient rehabilitation setting. During the therapy session 4-8 sensors will be applied to participant over their clothing. As the participant performs various subtasks of MPPT the wearable sensors will provide measurements. At the same time the physical or occupational therapist will do measurements on the same subtasks in the traditional way which is based on observation and time to complete a task. A gaming component is being added to the sub task of balance. For the subtask of balance the participant will be wearing the wearable sensor for balance and at the same time will be looking at an animation on a screen. The participant will try to control a moving object on the gaming screen with their balance. The scoring on the gaming component also gives a digital score of the participants balance. In this case of the balance subtask the physical therapist will do the measurement of the balance in the traditional way with observation and time to complete the subtask. The performance of all subtasks by the participants, will be with a licensed physical therapist as part of the routine physical therapy evaluation and treatment session.

The schedule of digital measurements of physical performance by wearable sensors for each participant will be on THREE occasions as follows:

1. During the initial physical and occupational therapy evaluation session -approximately 1 hour duration

2. During a physical/occupational therapy session within 1 -2 weeks after the initial evaluation - approximately 1 hour duration

3. During a physical/occupational therapy session within 1-2 weeks after the second evaluation or at time of discharge - approximately 1 hour duration

Conditions

Physical Performance

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Modified Physical Performance test (MPPT)

Participants will perform MPPT with and without the wearable seonsors.

IMU (Inertial Measurement Unit) sensors

Intervention Type: 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.

Interventions

IMU (Inertial Measurement Unit) sensors

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rummana Aslam, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital Rehabilitation and Wellness center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000034742

Identifier Type: -

Identifier Source: org_study_id