The Effect of Telerehabilitation-Based Exercise and Training on Outcome Measures in Patients With Knee Osteoarthritis

The Effect of Telerehabilitation-Based Exercise and Training Combination on Pain, Function, Balance, Proprioception and Quality of Life in Patients With Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Knee Arthritis
• Intervention / Treatment: Other: Telerehabilitation; Other: Paper Based Rehabilitation

Detailed Description

Owing to telerehabilitation, exercise video suppliment will enable individuals to learn the exercise programs in the most appropriate way, have comprehensive information about their condition, and communicate easily with their physiotherapists. 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Muğla, Turkey
    • Muğla Sıtkı Koçman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation (TR); The TR group will be followed up through the application within the 8-week home exercise program.	Other: Telerehabilitation; Application based video home exercise for the knee osteoarthritis
Active Comparator: Paper Based Rehabilitation (PBR); The PBR group will be followed up through the paper instruction within the 8-week home exercise program.	Other: Paper Based Rehabilitation; Paper instruction based home exercise for the knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-5L	The patient is asked to indicate the state of health by marking the most appropriate expression in each of the five dimensions. Index score of the EQ-5D-5L is ranged between 1 to - 0.285. Higher scores indicate better quality of life. VAS score of the EQ-5D-5L is ranged between 0 to 100. Higher scores indicate better quality of life.	Change from Baseline General Quality of Life at 8 weeks
Telemedicine Satisfaction Questionnaire	This questionnaire consists of 14 items. The level of satisfaction of the patients with the software or system from which they receive treatment or other remote rehabilitation services is evaluated. The tool uses a 5-point Likert scale (1 = strongly disagree, 7 = strongly agree). The total score varies between 14-70 for 14 questions with a maximum of 5 points. Higher scores indicate better satisfaction.	Change from Baseline General Telemedicine Satisfaction at 8 weeks
Telehealth Usability Questionnaire	The questionnaire consists of 21 items evaluating the distance rehabilitation service. The questionnaire uses a 7-point Likert-type scale (1 = disagree, 7 = agree). The total score is calculated by summing up 21 items.	Change from Baseline General Usability Satisfaction at 8 weeks

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): July 5, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Knee Osteoarthritis; Gonarthrosis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 24/III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No