Validity of AI in Treatment of the Musculoskeletal Conditions by Vifive

November 20, 2024 updated by: Eugene Roh, Stanford University
The purpose of this study is to evaluate the efficacy of the 12-week ViFive program, a vision-based artificial intelligent digital care plan for chronic knee pain. ViFive digital care plan is delivered by a physical therapy team consisting of physical therapists and a personal coach. We aim to understand the safety and efficacy of this vision artificial intelligent based home exercise program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is recruiting patients who present with knee osteoarthritis and shoulder adhesive capsulitis through evaluation by the treating physician. A brief physical functional assessment will be conducted to ensure eligibility and assess for any safety concerns (e.g., minimum strength and capability to conduct basic rehabilitation exercises).

Once subject is enrolled and device is distributed and set up, participants will follow and complete the VIFive program on the device.

ViFive DCP (Digital Care Program) is a highly structured, protocolized, and individually tailored intervention consisting of personalized exercise therapy modules. ViFive DCP is delivered by a physical therapy team consisting of DPTs and a personal coach. The DCP consists of ten modules and its advancement will be determined by each patient's progress after the treatment team's review every week. The primary aim of ViFive DCP is to assist patients in recovering their appropriate daily physical activity level by strengthening the knee and educating proper interpretation of sensation rather than pain. ViFive DCP represents a mobile intervention platform utilizing vision-AI. Vision AI enables objective and precise exercise prescription along with transparent patient monitoring. As a platform, there is an interface for patients and clinicians. Each module consists of a specific exercise treatment plan, educational articles, and instructions to promote changes in daily life. Each of these modules has specific goals, and patients are able to follow a predefined sequence of modules. ViFive DCP includes illustration, voice guidance, and pose correction features of AI coach. During treatment, patients have regular contact with their personal coach through a message functioning (e.g., exercise progress, answers to questions, patient receives feedback from the coach, can ask the coach questions, etc). The coach provides continuous feedback on completed tasks and responds to concerns the patient may have. Weekly feedback on progress is also provided. In total, the coach spends approximately 12 hours per patient throughout treatment.

After completion of the program, device will be returned.

Participants are to complete questionnaires, consisting of KOOS, VAS, and surgery interest at baseline, 3-month, and 6-month. VAS will be used to assess changes in pain level. KOOS will be used to assess knee functional outcome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Stanford University Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1.Age 18-60 years old
  • Diagnosis of adhesive capsulitis or
  • Diagnosis of knee osteoarthritis

Exclusion Criteria:

  • Age <18 or >60 years old
  • acute injuries or recent surgeries to the knee or shoulder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ViFIVE Digital Care Program
AI based digital care program that is individually tailored for each user depending on need. ViFive DCP includes illustration, voice guidance, and pose correction features of AI coach. Participants will required to complete the program.
Device: ViFIVE Digital Care Progrma
ViFive DCP (Digital Care Program) is a highly structured, protocolized, and individually tailored intervention consisting of personalized exercise therapy modules. ViFive DCP is delivered by a physical therapy team consisting of DPTs and a personal coach. The DCP consists of ten modules and its advancement will be determined by each patient's progress after the treatment team's review every week.
Other Names:
  • ViFIVE DCP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcomes Score
Time Frame: 6 months
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms). 100 indicating the best score, and 0 indicating the worst score.
6 months
Visual Analogue Scale
Time Frame: 6 months
Patient reported outcome measure that reports pain intensity on a scale of 0-10 (10 being extreme pain and 0 no pain at all). 10 indicating the worst score and 0 indicating the best score.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Surgery Interest
Time Frame: 6 months
Patient reported outcome measure determining participant's interest in surgery on a scale of 1 to 10 (10 being very interested and 1 being not at all interested).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ViFIVE Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 63794

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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