Back to resultsThe Effect of Telerehabilitation-Based Exercise and Training on Outcome Measures in Patients With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee Arthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
Paper Based Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Gonarthrosis, Knee Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- Muğla Sıtkı Koçman Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telerehabilitation (TR)
Paper Based Rehabilitation (PBR)
Arm Description
The TR group will be followed up through the application within the 8-week home exercise program.
The PBR group will be followed up through the paper instruction within the 8-week home exercise program.
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS)
On a 10 cm straight line or numerical scale (0: no pain, 10: unbearable pain).
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).
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05209893
Brief Title
The Effect of Telerehabilitation-Based Exercise and Training on Outcome Measures in Patients With Knee Osteoarthritis
Official Title
The Effect of Telerehabilitation-Based Exercise and Training Combination on Pain, Function, Balance, Proprioception and Quality of Life in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
July 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee Arthritis
Keywords
Gonarthrosis, Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation (TR)
Arm Type
Experimental
Arm Description
The TR group will be followed up through the application within the 8-week home exercise program.
Arm Title
Paper Based Rehabilitation (PBR)
Arm Type
Active Comparator
Arm Description
The PBR group will be followed up through the paper instruction within the 8-week home exercise program.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
Application based video home exercise for the knee osteoarthritis
Intervention Type
Other
Intervention Name(s)
Paper Based Rehabilitation
Intervention Description
Paper instruction based home exercise for the knee osteoarthritis
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
On a 10 cm straight line or numerical scale (0: no pain, 10: unbearable pain).
Time Frame
Change from Baseline Pain at 8 weeks
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
WOMAC consists of 3 main headings: pain intensity, stiffness, and physical function. The total score ranges from 0 (no disability) to 96 (complete disability).
Time Frame
Change from Baseline Subjective Function at 8 weeks
Title
Muscle Strength Test with Lafayette Hand Held Dynamometer
Description
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.
Time Frame
Change from Baseline Muscle Strength at 8 weeks
Title
Proprioception Measurement with Baseline Bubble Inclinometer
Description
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.
Time Frame
Change from Baseline Proprioception at 8 weeks
Title
Timed Up and Go Test (TUG)
Description
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.
Time Frame
Change from Baseline "Timed Up and Go" test performance at 8 weeks
Title
Five Times Sit to Stand Test (5TSTS)
Description
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.
Time Frame
Change from Baseline "Five Times Sit to Stand" test performance at 8 weeks
Title
3-Meter Backward Walk Test (3MBW)
Description
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.
Time Frame
Change from Baseline "3-Meter Backward Walk" test performance at 8 weeks
Title
Modified Four Square Step Test (mFSST)
Description
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.
Time Frame
Change from Baseline "Modified Four Square Step" test performance at 8 weeks
Secondary Outcome Measure Information:
Title
EQ-5D-5L
Description
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.
Time Frame
Change from Baseline General Quality of Life at 8 weeks
Title
Telemedicine Satisfaction Questionnaire
Description
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.
Time Frame
Change from Baseline General Telemedicine Satisfaction at 8 weeks
Title
Telehealth Usability Questionnaire
Description
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.
Time Frame
Change from Baseline General Usability Satisfaction at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cem Yalın Kılınç, MD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emre Gültaç, MD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muğla Sıtkı Koçman Training and Research Hospital
City
Muğla
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Telerehabilitation-Based Exercise and Training on Outcome Measures in Patients With Knee Osteoarthritis
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