Validity of AI in Treatment of the Musculoskeletal Conditions by Vifive

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05290272
Collaborator
ViFIVE Inc. (Other)
50
1
21.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ViFIVE Digital Care Progrma
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Validity of AI in Treatment of the Musculoskeletal Conditions by Vifive
Anticipated Study Start Date :
Mar 30, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score [6 months]

      Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms

    2. Visual Analogue Scale (VAS) [6 months]

      Patient reported outcome measure that reports pain intensity.

    Secondary Outcome Measures

    1. Surgery Interest [6 months]

      Patient reported outcome measure determining participant's interest in surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Stanford University
    • ViFIVE Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eugene Roh, Clinical Associate Professor, Stanford University
    ClinicalTrials.gov Identifier:
    NCT05290272
    Other Study ID Numbers:
    • 63794
    First Posted:
    Mar 22, 2022
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 22, 2022