The demographic questionnaire consisting of participants (sex, age, body mass index, education) and history of postoperative orthopedic rehabilitation will be performed before the treatment.
3.1.1 NRS-the Maximum and the average pain
NRS requires patients to rate their pain level on the defined scale form. For a scale range of 0–10, 0 means the absence of pain, whereas 10 shows the worst pain imaginable [21, 22]. Given the positive correlation of NRS with other measures of pain, it is considered as a valid and reliable measure. Additionally, NRS shows sensitivity to pain treatments that are anticipated to affect pain scale [23]. Considering that NRS scale is an interval-level scale, it can offer data for sensitivity analysis of the solution to the problem at hand. Also, NRS has been used to deliver graphical or verbal analysis of data [24].
3.1.2 KOSS
KOOS has a 42-item self-administered self-explanatory questionnaire that includes five divisions, namely, pain, additional symptoms, function in daily living, function in sport and recreation, and knee-related quality of life [25]. The scale scores range from 0 to 100. Zero refers to the worst and most extreme knee problems, whereas 100 refers to the best knee health with no problem [26]. Typically, a KOOS aggregate score is not calculated because of the desire to analyze and interpret the five dimensions individually [27]. In addition, an MICD of 8–10 is considered appropriate for KOOS [28].
Secondary outcome measures
3.1.3 Cognitive assessments
1). Cognitive performance test (CPT): each participant will be asked to complete the following cognitive tests; executive function (trial making test A/B), working memory (n-back task), attention (digital span test), neural processing speed (digital symbol substitution test), and cognition inhibition (flanker task) [29]. Using concurrent validity, the CPT has been validated by comparison with other measures of daily and cognition activities [30].
2). Rey Auditory Verbal Learning Test (RAVLT) has a 15 noun-word list, which is used to evaluate learning and memory. The RAVLT test is widely used in neuropsychology literature [29]. In the RAVL test, 15 words will be presented for the participants to read at a rate of “one word per second.” After viewing the 15 words, the participants will be required to remember many words, in no specific order. This testing procedure will be repeated five times with each participant [31].
3). Digit Span Task (DST) is a task that consists of two spans: a Digit Span Forward and Digit Span Backward. The DST is used to evaluate a person’s attention and verbal working memory [32]. During the DST, the participants will first be required to listen to a sequence of numbers. Then, they will be guide to repeat the same sequence in the forward or backward order. The forward span will be used to evaluate the participants’ attention efficiency and capacity, whereas the backward span will be used to evaluate their working memory [33].
3.1.4 Physical assessments
In this protocol, the physical assessment portion will be completed by the following four validated questionnaires:
1). The 6 min walk test (6MWT): 6MWT is a short walk test that measures the recovery of function after TKA [34]. This test requires the patients to walk around in a set of walking circuits for 6 min. In this text, 14.0 m to 30.5 m may be clinically important across different groups [35]. Notably, the 6MWT is a valid test to measure the patients’ functional outcomes after TKA [36].
2). Time up and go (TUG): TUG is a short walk test that measures the recovery of function after TKA [37]. This test evaluates the duration of the following process: without assistance, the patient rises from an armchair (seat height, 46 cm), walks for 3 m, turns, and returns and sits in the same chair [38].
3). Manual muscle testing (MMT): MMT assesses the knee joint muscle strength [39]. The MMT does not employ any equipment to evaluate the strength of the participants. Rather, it employs the following ratings: 0 as zero (O), 1 as trace (T), 2 as poor (P), 3 as fair (F), 4 as good (G), and 5 as normal (N). The MMT procedure assesses the function and strength of the participant’s muscles based on their effectiveness when performing a movement. Their ability to perform a movement is assessed by comparing with gravity and resistance.
4). Berg Balance Scale (BBS): BBS is a tool for balance assessment and it is a standard for measuring balance for patients with TKA in medical settings [40]. This test consists of the 14 movement tasks [41]. Each of the 14 tasks will be scored using a 5-point ordinal scale from 0 to 4. The 0 refers to the individual’s inability to perform the task, whereas 4 refers to the individual’s ability to independently complete the task [42]. In research done with older adults, the BBS scores are organized according to their performance in the functional status and their independence. Hence, the BBS scores are organized into the following three ranges: (a) in the first range, 0 to 20 means that mobility is available, albeit wheelchair-bound; (b) 21 to 40 means that people are walking with assistance; and (c) 41 to 56 means that people are walking independently [42].
5). Knee Range of Motion (ROM): postoperative knee range of motion is a key factor influencing the patient’s satisfaction after TKA [43]. ROM includes the assessment of knee flexion and extension, tibial internal, and external rotation [44]. On average, most individuals have around 0 degrees when the knee is fully straightened and around 135 degrees when the knee is flexed [45]. There are three types of ROM at a joint, namely, active knee ROM, passive knee ROM, and active assisted ROM.
To identify any adverse or seriously adverse events that occur before the 40-week period, the following 3 methods will be used: a). copy of hospital records, b). patient self-report at follow-up visit, and c). report by the therapist. Adverse events are classified as those involving the index knee or sites other than the index knee. However, serious adverse events are recognized based on the U.S. Food and Drug Administration definition [28].
3.1.5 Mood assessments
The mood assessments will be measured by the following two instruments:
1). Self-Rating Depression Scale (SDS): the scale is allow the participants to reflect on their subjective depression experiences and depression severity, as well as any changes in depression [46]. According to the standard score, 53 points or less indicate that the participants do not suffer from depression, whereas scores above 53 points indicate that the participants suffer from depressive disorder. In other words, the higher the SDS score is, the higher the rate of depression is [45].
2). Self-rating anxiety scale (SAS): this scale is a norm-referenced measurement that is widely used as a screening scale for anxiety disorders [47]. The scale consisted of 20 questions, 15 of which dealt to increasing level of anxiety levels; the other five questions pertain to the decrease in anxiety [45]. The score of this test ranges from 20 to 80. Normal range is from 20 to 44 points; 45–59 points indicates a mild to moderate level of anxiety; a score of 60–74 indicates a significant anxiety level; and a score of 75–80 indicates extreme levels of anxiety [48].
3.1.6 Others
Some other assessments are as follows:
1). Short-form 12 (SF-12): the SF-12 is a measure that is widely used to assess the impact of health on an individual’s daily life [49]. Using this form, participants will fill out a 12-question survey, which will be scored by a clinician or researcher. These 12 questions measure eight domains that can be used to calculate the physical and psychological scores of participants. This measurement represents satisfactory internal consistency for the physical component (Cronbach’s alpha = 0.81) and mental component summary (Cronbach’s alpha = 0.83) [50].
2). Pittsburgh Sleep Quality Index (PSQI): the PSQI is used assess the overall quality of sleep in clinical populations. The questionnaire has seven subcategories with a total of 19 self-reported items. The questionnaire’s seven subcategories, such sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction [51]. The questions will be scored from 0 to 3; higher scores show the presence of acute sleep disturbances. Based on the results of a validation study, the scale has suggested a cutoff score of 5 [51]. The PSQI has an excellent test-retest reliability with a correlation coefficient of 0.77 [52].
3). Instrumental Activities of Daily Living Scale (IADL): this test is used to evaluate the independent living skills [53]. This scale includes eight domains that measure function. Considering that some of these domain items pertain to food preparation, housekeeping, and laundering, women will be scored on all of these items, whereas men will be scored on everything else. All participants will be scored according to their highest level of functioning in each of the eight categories. The score summary for women will range from 0 (low function, dependent) to 8 (high function, independent), whereas men will be scored from 0 to 5 [54].
We will also record the number of sessions that each participant attends and the reason for absence. Meanwhile, the occurrence of adverse events about interventions and sessions at home will be measured.