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Validity of AI in Treatment of the Musculoskeletal Conditions by Vifive

Primary Purpose

Shoulder Adhesive Capsulitis, Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ViFIVE Digital Care Progrma
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Adhesive Capsulitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Hospitals and ClinicsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ViFIVE Digital Care Program

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
March 11, 2022
Last Updated
March 17, 2023
Sponsor
Stanford University
Collaborators
ViFIVE Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05290272
Brief Title
Validity of AI in Treatment of the Musculoskeletal Conditions by Vifive
Official Title
Validity of AI in Treatment of the Musculoskeletal Conditions by Vifive
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
ViFIVE Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Adhesive Capsulitis, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ViFIVE Digital Care Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ViFIVE Digital Care Progrma
Other Intervention Name(s)
ViFIVE DCP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcomes Score
Description
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.
Time Frame
6 months
Title
Visual Analogue Scale
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Surgery Interest
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University Hospitals and Clinics
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Agnes Ith, MD
Phone
650-721-7600
Email
mith@stanford.edu
First Name & Middle Initial & Last Name & Degree
Shannon Schultz, BA
Phone
6507252897
Email
sks01@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Validity of AI in Treatment of the Musculoskeletal Conditions by Vifive

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