NCT05209893

Brief Summary

Video exercise component of the telerehabilitation would provide additional contribution to the patients. The aim of this study is to compare the effects of telerehabilitation-based exercise program and conventional (given on paper) exercise and training combination practices on pain, functionality, balance, proprioception and quality of life in patients with knee OA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 6, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

January 6, 2022

Last Update Submit

July 20, 2022

Conditions

Keywords

GonarthrosisKnee Osteoarthritis

Outcome Measures

Primary Outcomes (8)

  • Visual Analog Scale (VAS)

    On a 10 cm straight line or numerical scale (0: no pain, 10: unbearable pain).

    Change from Baseline Pain at 8 weeks

  • 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 Subjective Function at 8 weeks

  • Muscle Strength Test with Lafayette Hand Held Dynamometer

    It is an objective muscle strength measurement tool. Measurements are made 3 times. A rest of 120 seconds is given between measurements. The highest measured value is noted.

    Change from Baseline Muscle Strength at 8 weeks

  • Proprioception Measurement with Baseline Bubble Inclinometer

    The "absolute angle difference", which is the difference between the targeted angle and the angle realized by the patient in each repetition, is recorded. The arithmetic mean of the absolute angle difference of 3 repetitions is the result data.

    Change from Baseline Proprioception at 8 weeks

  • Timed Up and Go Test (TUG)

    Patients are asked to get up from a standard chair, walk 3 meters a safe and comfortable pace, and return without stopping to sit back in the chair safely. The elapsed time is calculated.

    Change from Baseline "Timed Up and Go" test performance at 8 weeks

  • Five Times Sit to Stand Test (5TSTS)

    The test involves patients getting up and sitting again without support from a chair 5 times as soon as possible. Measurements are made with a stopwatch.

    Change from Baseline "Five Times Sit to Stand" test performance at 8 weeks

  • 3-Meter Backward Walk Test (3MBW)

    It is determined by measuring a distance of 3 meters. Participants are asked to walk backwards safely but as quickly as possible and stop at the finish line. The time is recorded with a stopwatch.

    Change from Baseline "3-Meter Backward Walk" test performance at 8 weeks

  • Modified Four Square Step Test (mFSST)

    A suitable ground is divided into four identical squares with a "+" shaped line. Squares are numbered clockwise with numbers 1-4. The patient takes steps on the 1, 2, 3 and 4 squares in sequence without pressing the lines.The test ends when the last foot contact is cut off from the square. The time is recorded with a stopwatch.

    Change from Baseline "Modified Four Square Step" test performance at 8 weeks

Secondary Outcomes (3)

  • EQ-5D-5L

    Change from Baseline General Quality of Life at 8 weeks

  • Telemedicine Satisfaction Questionnaire

    Change from Baseline General Telemedicine Satisfaction at 8 weeks

  • Telehealth Usability Questionnaire

    Change from Baseline General Usability Satisfaction at 8 weeks

Study Arms (2)

Telerehabilitation (TR)

EXPERIMENTAL

The TR group will be followed up through the application within the 8-week home exercise program.

Other: Telerehabilitation

Paper Based Rehabilitation (PBR)

ACTIVE COMPARATOR

The PBR group will be followed up through the paper instruction within the 8-week home exercise program.

Other: Paper Based Rehabilitation

Interventions

Application based video home exercise for the knee osteoarthritis

Telerehabilitation (TR)

Paper instruction based home exercise for the knee osteoarthritis

Paper Based Rehabilitation (PBR)

Eligibility Criteria

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

You may qualify if:

  • Patients aged between 40 to 65 years
  • Being diagnosed with knee osteoarthritis by an orthopedist
  • Having a value of 1 or 2 in the Kellgren Lawrence classification
  • Having and being able to use the equipment to receive video-based exercise and education support
  • Having signed the consent form

You may not qualify if:

  • Situations that will prevent assessments or communication with the individual
  • Knee surgery history
  • Having other joint pathologies
  • Orthopedic and neurological problems that would prevent evaluation and/or treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla Sıtkı Koçman Training and Research Hospital

Muğla, Turkey (Türkiye)

Location

Related Publications (1)

  • Tumturk I, Bakirhan S, Ozden F, Gultac E, Kilinc CY. Effect of Telerehabilitation-Based Exercise and Education on Pain, Function, Strength, Proprioception, and Psychosocial Parameters in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial. Am J Phys Med Rehabil. 2024 Mar 1;103(3):222-232. doi: 10.1097/PHM.0000000000002335. Epub 2023 Sep 5.

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

ArthritisJoint 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

    PRINCIPAL INVESTIGATOR
  • Cem Yalın Kılınç, MD

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR
  • Emre Gültaç, MD

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd, Associate Professor

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 27, 2022

Study Start

January 24, 2022

Primary Completion

May 27, 2022

Study Completion

July 5, 2022

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations