Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS) |
This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain (Childs et al, 2005). The examinee is asked to choose an integer that best reflects the intensity of their pain. The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity. |
pre-treatment, week: 3, 6, 6-month follow-up |
|
| Primary |
Changes in active Range of Motion (active ROM) of the knee joint flexion |
Active range of knee flexion will be assessed with a long arm goniometer. The measurement will be performed with the subject supine on the examination bed based on the instructions by Hancock et al. (2018), according to whom, measurement with a long arm goniometer shows very high reliability. Three consecutive bends will be requested from the examinee and the highest measured value will be recorded. |
pre-treatment, week: 3, 6, 6-month follow-up |
|
| Primary |
3. Changes in functional capacity with the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire |
The KOOS questionnaire is a self-report questionnaire for the assessment of functional limitations related to knee injuries or osteoarthritis (Roos et al. 1998). It is used both in research to assess functional ability and in clinical practice. It includes 42 questions which are divided into 5 subscales: knee pain, other knee symptoms, functional limitations, ability to participate in sports or leisure activities and quality of life. A five-point Likert scale from 0 (No problems) to 4 (Extreme problems) is used to score the questionnaire. The final score results from the sum of the five separate subcategories. A higher score implies greater functional limitations. In our research, the Greek version of the questionnaire will be used, which according to Moutzouri et al. (2003) shows excellent internal consistency and good reliability from one measurement to another (test-retest reliability). |
pre-treatment, week: 3, 6, 6-month follow-up |
|
| Primary |
Changes in quality of life with Western Ontario and McMaster Universities Arthritis (WOMAC) index |
The WOMAC index is widely used in the assessment of the quality of life of people with osteoarthritis of the hip and knee (Salafi et al. 2005). It is a self-report questionnaire consisting of 24 questions classified into three subscales: Pain, knee joint stiffness and functional ability in everyday skills.Test questions are scored on a scale of 0 to 4. Scores for each subscale are summed, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for functional ability. A sum of the scores for all three subscales gives a total WOMAC score. The higher the score, the less functional the joint.The internal consistency of the subcategories of the Greek WOMAC version ranges from high (0.804) to excellent (0.956), while the intra-class correlation coefficients for test-retest reliability have been characterized as excellent (ranging between 0.91 - 0.95) (Papathanasiou et al. 2015). |
pre-treatment, week: 3, 6, 6-month follow-up |
|
| Primary |
Changes in CONFbal - GREEK score questionnaire |
The CONFbal questionnaire is a tool that assesses the self-esteem of an elderly person associated with the risk of falling. It consists of a 10-item scale, which are summed to give an index of balance confidence. The score ranges from 10 to 30. A higher score indicates lower balance confidence. ?he questionnaire demonstrates excellent internal consistency and excellent test-retest reliability. The Greek version of the questionnaire CONFbal - GREEK (Billis, et al., 2011) will be used in this study. |
pre-treatment, week: 3, 6, 6-month follow-up |
|
| Primary |
Changes in Timed Up and Go test |
It is a simple test used to assess a person's mobility. It requires both static and dynamic balance and is a valid and reliable indicator of the functional ability of an individual (Podsiadlo & Richardson, 1991). The participant starts in a seated position. They then stand up following the instructions of the therapist, walk three meters, turn around, walk back to the chair and sit down. The examiner tracks time using a stopwatch. Time is calculated in seconds. A higher score indicates lower functional ability of the participant. The TUG shows high reliability indices in older adults both in measurements by different examiners and in measurements by the same examiner at different times (Cameron and Monroe, 2007). |
pre-treatment, week: 3, 6, 6-month follow-up |
|
| Primary |
Changes in Berg Balance scale Test |
The Berg Balance Scale is a tool proposed by Berg (Berg et al., 1989; Berg et al., 1992) for assessing balance in the elderly. The test involves the execution of 14 tests of gradual increasing difficulty where in each one, the subject is asked to maintain a given position for a specific time or conduct specific tasks. Each of the 14 tests on the list is graded according to the balancing ability of the examinee from 0 to 4 points (with 0 indicating low balance ability, while 4 indicates high balance ability). According to Berg et al. (1992), a score of 56 indicates functional balance, whereas a score lower than 45 indicates notable balance deficits that have been related to increased fall risk. Studies have shown high intra-rater and inter-rater reliability in the elderly populations with intraclass correlation (ICC) ranging from .98 to .88 (Berg et al. 1992) and high content validity (Telenius et al., 2015). |
pre-treatment, week: 3, 6, 6-month follow-up |
|
| Primary |
Changes of center of mass (COM) displacement |
Changes of COM displacement will be recorded through static postulography based of the protocol of Wanderley et al. (2011). To perform this test, participants will be asked to remain barefoot and static for one minute while standing at ease on the force platform with feet shoulder-width apart and gazing at a target placed at 2m. Three attempts will be performed with one-minute intervals in-between. The same procedure will be repeated with eyes closed. Three types of posturographic variables will be analyzed: center of pressure (CoP), sway area, which refers to CoP sway with a 95% ellipse area; CoP sway velocity; and CoP sway frequency (80% power spectrum). All variables will be analyzed in the anterior-posterior and medial-lateral directions. The mean value for the 3 attempts for each variable will be calculated and will be used for analysis. |
pre-treatment, week: 3, 6, 6-month follow-up |
|
| Primary |
Chances in knee joint position sense |
Joint position sense will be calculated using an isokinetic dynamometer according to the protocol of Ma et al. (2022). The measurement will be performed according to Borsa et al. (1997) at three angles: 30°, 60° and 90° with the knee moving from full extension (180°) to flexion. During the measurement, the examinee will be asked through a switch in their hand to stop the movement at the specific angles. Each pause of the system via the switch at the reference angles will be noted and the difference in degrees of the recorded angle from the actual angle will be used as the variable. |
pre-treatment, week: 3, 6, 6-month follow-up |
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