Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 12:59 AM
Study NCT ID:
NCT06564350
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2024-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digitalization of Measuring Physical Performance
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Digitalization of Measuring Physical Performance
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: