- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06489847
An Objective Assessment Tool for Evaluating Functioning in Older Adults (SPPB++)
The Investigators are seeking your consent to participate in research investigating the development of a mobile application that enhances physical and cognitive assessments.
This is in response to the growing significance of the Short Physical Performance Battery (SPPB) in Alzheimer's Disease and Related Dementias (AD/ADRD) research. The SPPB has proven its value in evaluating lower extremity function and mobility in older adults, providing predictive insights into declines in daily living activities, falls, hospitalization, disability, and mortality.
Recognizing the need for accessible and automated assessment tools, this project endeavors to design a mobile app with multi-fold functionality. The final version will guide users through SPPB tests, offer real-time performance scoring, and facilitate frequent, objective, and accurate physical and cognitive assessments. This is particularly critical for monitoring the progression of ADRD, identifying subtle physical changes indicative of cognitive decline, and enabling timely interventions tailored to patients' evolving needs.
Our goal is to collect video data from 20 to 30 participants 18+ years of age who are considered healthy with no severe mobility issues to perform the SPPB. The video data will be used to develop a prototype of the SPPB application and validate testing in the lab. The video recording will be automatically encrypted and securely uploaded to Stanford privacy protected computer servers to test and refine the application results.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94304
- Clinical Excellence Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (18+)
- proficient in English
- consider themselves healthy
- Ability to participate in a meeting for consenting and video data collection on Stanford campus
Exclusion Criteria:
- We will exclude participant that do not consent to video data collection
- Under the age of 18
- limited physical mobility.
We have no exclusions on the basis of gender or ethnic background.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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develop an automated analysis of the SPPB clinical tests
Time Frame: 1 year
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Novel Biomarker Types: In this study, we propose to leverage video data to develop an automated analysis of the SPPB clinical tests, the same way that MRI data can automatically be analyzed.
This will remove the need for subjective evaluation and lead to universally acceptable disease (digital) biomarkers from the video data, helping the clinicians.
The video-based biomarkers will serve as quantifiable identifiers singling out specific subtype(s).
Such digital biomarkers [9-19,21] and especially video [20] are transforming the development of drugs.
Video, as a rich source of data, can provide novel information yet to be explored.
|
1 year
|
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large-scale data collection to continuously collect data for understanding NPS disease trajectories
Time Frame: 1 year
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Novel Methodologies: Processing unconstrained video data collected in clinical settings with limited data points calls for new technologies.
Although we use recent video recognition technologies (including those developed by us recently), applying them to clinical data and training new machine learning models poses unique challenges requiring novel methods.
In addition, implementing this on mobile phones will facilitate the platforms required for large-scale data collection to continuously collect data for understanding disease trajectories.
|
1 year
|
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SPPB++ mobile phone app
Time Frame: 1 year
|
Impact: We will implement our novel algorithms in a mobile phone app, making the tests accessible and affordable to many individuals.
This will enable large-scale data collection and clinical trials.
The analysis of this data will identify novel biomarkers using video-based SPPB tests.
The longitudinal assessment of these tests will provide a means for tracking cognitive functioning and convergence to MCI, AD, or other dementia.
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ehsan Adeli, PhD, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 74617
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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