Multimodal, Task-Aware Movement Assessment and Control: Clinic to the Home

The investigators seek to construct a novel, multimodal, distributed system that facilitates a new paradigm of home-based medical surveillance and treatment for frail older adults centered on timely diagnosis of movement system impairments and personalized intervention. Measurements from a heterogeneous set of complementary sensors will be combined with clinically-informed and data-learned dynamic models of human motion to enable real-time activity recognition (e.g., sitting, standing, walking) and movement assessments (e.g., speed, repetition, quality). As the study progresses, the system will be integrated with wearable assistive technology to provide "smart", activity-specific assistance of movement deficits or the activation of caregivers if a decline in function is detected. Finally, the investigators will test the combined assessment and intervention system in the clinic and the home, identifying challenges and solutions for the scaling up to unconstrained real-world settings.

Study Overview

• Status: Recruiting
• Conditions: Frailty

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: David M Levine, MD, MPH, MA; Phone Number: 617-732-7063; Email: dmlevine@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: David M Levine, MD MPH MA; Phone Number: 617-732-7063; Email: dmlevine@partners.org
      • Principal Investigator: David M Levine, MD MPH MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of frail adults and frail older adults. Frailty is defined as a state of increased vulnerability and reduced ability to recover after a stressful event, leading to adverse health outcomes.

Description

Inclusion Criteria:

• Age >= 18 years
• Capacity to consent
• Community dwelling
• Ability to follow 3-step commands
• Lives within 15 miles of Boston

Exclusion Criteria:

• Undomiciled
• Active substance use disorder
• Active psychosis
• Domestic violence or neglect
• Inability to communicate with investigators
• Other comorbidities that prevent full participation in the research

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Video and inertial motion unit capture	Successfully capture video and inertial motion unit capture of subjects as they perform various movement assessments.	1 recording episode, approximately 3 hours

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Boston University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 2, 2023

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 2020P003474

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No