Validity of AI in Treatment of the Musculoskeletal Conditions by Vifive

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: Recruiting
• Conditions: Knee Osteoarthritis; Shoulder Adhesive Capsulitis
• Intervention / Treatment: Device: ViFIVE Digital Care Progrma

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: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford University Hospitals and Clinics
      • Contact: Ma Agnes Ith, MD; Phone Number: 650-721-7600; Email: mith@stanford.edu
      • Contact: Shannon Schultz, BA; Phone Number: 6507252897; Email: sks01@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery Interest	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

• Sponsor: Stanford University
• Collaborators: ViFIVE Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Anticipated): January 30, 2024
• Study Completion (Anticipated): January 30, 2024

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Bursitis
• Other Study ID 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