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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04675307
• Other study ID #: 2020P003474
• Status: Recruiting
• Start date: February 17, 2021
• Est. completion date: December 2, 2023

Study information

• Verified date: March 2021
• Source: Brigham and Women's Hospital
• Contact: David M Levine, MD, MPH, MA
• Phone: 617-732-7063
• Email: dmlevine[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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