Validity of AI in Treatment of the Musculoskeletal Conditions by Vifive
1 other identifier
interventional
35
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 22, 2022
CompletedStudy Start
First participant enrolled
January 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2024
CompletedNovember 22, 2024
November 1, 2024
1.4 years
March 11, 2022
November 20, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Knee Injury and Osteoarthritis Outcomes Score
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
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 Outcomes (1)
Surgery Interest
6 months
Study Arms (1)
ViFIVE Digital Care Program
EXPERIMENTALAI 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age 18-60 years old
- Diagnosis of adhesive capsulitis or
- Diagnosis of knee osteoarthritis
You may not qualify if:
- Age \<18 or \>60 years old
- acute injuries or recent surgeries to the knee or shoulder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- ViFIVE Inc.collaborator
Study Sites (1)
Stanford University Hospitals and Clinics
Redwood City, California, 94063, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
March 11, 2022
First Posted
March 22, 2022
Study Start
January 30, 2023
Primary Completion
June 6, 2024
Study Completion
June 6, 2024
Last Updated
November 22, 2024
Record last verified: 2024-11