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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2022
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Telerehabilitation
Application based video home exercise for the knee osteoarthritis
Paper Based Rehabilitation
Paper instruction based home exercise for the knee osteoarthritis

Locations

Country Name City State
Turkey Mugla Sitki Koçman Training and Research Hospital Mugla

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

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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