NCT07066514

Brief Summary

This study aims to evaluate the effectiveness of an artificial intelligence (AI)-supported mobile application that supervises home-based exercise programs in patients with knee osteoarthritis. A total of 80 participants aged 40 to 80 will be randomly assigned to one of two groups: a mobile application exercise group or a home exercise booklet group. Both groups will receive the same standardized stretching, strengthening, and range of motion exercises designed for knee osteoarthritis. The mobile app provides real-time feedback and supervision using the device's camera and artificial intelligence algorithms to track and guide exercise performance. Participants in the app group will perform exercises with supervision via the app interface, while the control group will follow the same exercises using printed instructions. Both groups will exercise 3 to 4 times per week for 4 weeks. The study will compare pain levels, physical function, and balance before and after the intervention using validated outcome measures such as the WOMAC Index and the Visual Analog Scale. This study may help determine whether AI-supported digital tools can improve exercise adherence and outcomes in patients with knee osteoarthritis.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

May 6, 2026

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

July 4, 2025

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    The WOMAC is a validated questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. It consists of 24 items: 5 for pain, 2 for stiffness, and 17 for physical function. Each item is scored on a 5-point Likert scale (0 = none to 4 = extreme), with a total score range of 0 to 96. Higher scores indicate worse symptoms.

    Baseline and Week 4

  • Visual Analog Scale (VAS)

    Change in pain severity measured by the Visual Analog Scale (VAS; range: 0-10; higher scores indicate worse pain) at baseline and at 6 weeks.

    Baseline and Week 4

  • Timed Up and Go (TUG) Test

    Baseline and Week 4

  • Functional Reach Test (FRT)

    Baseline and Week 4

  • Single-Leg Stance Test

    Baseline and Week 4

  • Exercise Execution Accuracy Assessed by Mobile Application

    Accuracy of exercise adherence detection by the AI algorithm compared to physiotherapist assessment (% agreement)

    Before and during the 4-week intervention

Study Arms (2)

AI-Based Mobile Home Exercise Group

EXPERIMENTAL
Behavioral: AI-Supervised Mobile Exercise Program

Standard Home Exercise Group

EXPERIMENTAL
Behavioral: Booklet-Guided Home Exercise Program

Interventions

This intervention provides patients with a standardized home exercise program in printed booklet format. The program includes the same evidence-based stretching, strengthening, and range of motion exercises used in the mobile application group, performed 3-4 times per week for 4 weeks. Participants receive one-time in-person instruction on proper form but no ongoing supervision or feedback during the program. Adherence and technique are self-monitored.

Standard Home Exercise Group

This intervention involves the use of an artificial intelligence (AI)-supported mobile application that delivers a personalized exercise program to patients with knee osteoarthritis. The app supervises exercise execution in real time using the device's camera and AI algorithms to track movements, count repetitions, and assess form accuracy. The program includes stretching, strengthening, and range of motion exercises performed 3-4 times per week for 4 weeks. The app provides instructional videos, personalized feedback, reminders, and records user performance. No video or personal images are stored; only anonymized motion data are collected and securely stored.

AI-Based Mobile Home Exercise Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 40 and 80 years
  • Diagnosed with knee osteoarthritis according to ACR criteria
  • Referred to physical therapy by a physician for knee osteoarthritis
  • Able to use a smartphone or tablet
  • Having regular access to the internet
  • Voluntarily agrees to participate in the study

You may not qualify if:

  • History of knee surgery or currently undergoing surgical treatment
  • Received physical therapy or rehabilitation for knee OA within the past 6 months
  • Lack of access to a mobile device or internet
  • Any neurological, cardiovascular, or musculoskeletal condition that prevents safe participation in exercise
  • Cognitive impairment or psychiatric disorder interfering with exercise adherence
  • Inability to follow instructions or use the mobile app interface
  • Any condition that would contraindicate participation in a home-based exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludag University

Bursa, Nilüfer, Turkey (Türkiye)

Location

Related Publications (2)

  • Nelligan RK, Hinman RS, Kasza J, Crofts SJC, Bennell KL. Effects of a Self-directed Web-Based Strengthening Exercise and Physical Activity Program Supported by Automated Text Messages for People With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jun 1;181(6):776-785. doi: 10.1001/jamainternmed.2021.0991.

    PMID: 33843948BACKGROUND
  • Xiang XN, Wang ZZ, Hu J, Zhang JY, Li K, Chen QX, Xu FS, Zhang YW, He HC, He CQ, Zhu SY. Telehealth-Supported Exercise or Physical Activity Programs for Knee Osteoarthritis: Systematic Review and Meta-Analysis. J Med Internet Res. 2024 Aug 2;26:e54876. doi: 10.2196/54876.

    PMID: 39094114BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Prof

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 15, 2025

Study Start

August 1, 2025

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

May 6, 2026

Record last verified: 2025-07

Locations