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Active, Not Recruiting

NCT Number: NCT06489847

An Objective Assessment Tool for Evaluating Functioning in Older Adults

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Excellence Research Center

Palo Alto, California, 94304, United States

About this study

In response to the growing significance of the Short Physical Performance Battery (SPPB) in Alzheimer's Disease and Related Dementias (AD/ADRD) research, this project aims to create a mobile application that enhances physical and cognitive assessments. 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. Moreover, recent research has revealed the potential of SPPB in detecting cognitive decline through gait and hand movement analysis at various stages of AD and Mild Cognitive Impairment (MCI). Recognizing the need for accessible and automated assessment tools, this project endeavors to design a mobile app with multi-fold functionality. It 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPPB++ Application

Diagnostic Test

Participants will have video data collected as they perform the SPPB test one time.

Primary outcomes

  1. develop an automated analysis of the SPPB clinical tests

    Time frame: 1 year

    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.

  2. large-scale data collection to continuously collect data for understanding NPS disease trajectories

    Time frame: 1 year

    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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • University of Massachusetts, Worcester

Registry information

Acronym: SPPB++

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 8, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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