NCT06422910

Brief Summary

The aim of our study is to realize an exercise training and follow-up system that individuals with knee OA can easily adapt.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 2, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

May 15, 2024

Last Update Submit

May 15, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale (VAS)

    On a 0 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).

    Change from Baseline VAS at 8 weeks

  • The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    WOMAC consists of 3 main headings: pain intensity, stiffness and physical function. The total score ranges from 0 (no disability) to 96 (complete disability).

    Change from Baseline WOMAC at 8 weeks

  • Satisfaction and expectation assessment

    On a 0 cm straight line or numeric scale, the patient will be asked to mark their pre-treatment expectation and post-treatment satisfaction level. 0 will represent the lowest expectation and satisfaction and 10 the highest expectation or satisfaction.

    Change from Baseline Satisfaction and expectation assessment at 8 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL
Other: Telerehabilitation

Control Group

ACTIVE COMPARATOR
Other: Telerehabilitation

Interventions

Home exercises will be delivered through a video mobile application. In this application, exercises for knee osteoarthritis will be presented according to their types (stretching, strengthening, etc.). Videos deemed appropriate by the physiotherapist will be added to the exercise prescription and sent to the patients via message. Patients will have the opportunity to remotely access their own exercise prescription with visual, auditory and written commands. Translated with DeepL.com (free version)

Control GroupIntervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of primary knee osteoarthritis (OA) according to the American College of Rheumatology (ACR) criteria
  • Be qualified to use the mobile application and agree to use the application

You may not qualify if:

  • Individuals with poor cognitive function or inadequate reading skills
  • Individuals with neurological disorders that may affect mobility skills
  • Individuals who have undergone knee joint surgery and individuals with traumatic injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fethiye State Hospital

Muğla, Fethiye, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozden F, Tugay BU, Coban O, Suzek BE, Tugay N, Sari Z, Cetinkaya I, Cinbaz G, Tumturk I. Development of video exercise-based mobile application to improve the clinical outcomes in patients with knee osteoarthritis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Dec 27;18(1):39. doi: 10.1186/s13102-025-01503-w.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Fatih Özden, PhD

    Muğla Sıtkı Koçman University

    STUDY CHAIR
  • Baki Umut Tuğay, PhD

    Muğla Sıtkı Koçman University

    STUDY DIRECTOR
  • Barış Ethem Süzek, PhD

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR
  • Nazan Tuğay, PhD

    Sanko University

    PRINCIPAL INVESTIGATOR
  • Zübeyir Sarı, PhD

    Marmara University

    PRINCIPAL INVESTIGATOR
  • İrem Çetinkaya, MSc

    Haliç University

    PRINCIPAL INVESTIGATOR
  • Gülser Cinbaz, MSc

    İstanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 21, 2024

Study Start

May 2, 2023

Primary Completion

April 30, 2024

Study Completion

May 15, 2024

Last Updated

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations