Osteoarthritis Clinical Trial
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
NCT number | NCT05209893 |
Other study ID # | 24/III |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 24, 2022 |
Est. completion date | July 5, 2022 |
Verified date | July 2022 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | July 5, 2022 |
Est. primary completion date | May 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Mugla Sitki Koçman Training and Research Hospital | Mugla |
Lead Sponsor | Collaborator |
---|---|
Ege University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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