The effects of inspiratory muscle training on cardiorespiratory functions in juvenile idiopathic arthritis: A randomized controlled trial.

INTRODUCTION: Although inspiratory muscle training (IMT) has proven effective in adult rheumatic diseases, its impact on juvenile idiopathic arthritis (JIA) remains unexplored. The present study aimed to investigate the effects of IMT in children with JIA. METHODS: Thirty-three children (13-18 years) with JIA were divided into two groups as exercise (n = 17) and control (n = 16). The exercise group performed IMT at home daily for 8 weeks. The initial IMT load was set as 60% of maximal inspiratory pressure (PImax ) and increased by %10 of the initial load every 2 weeks. The control group received no additional intervention. Forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1 ), FVC/FEV1 , PImax , and maximal expiratory pressure (PEmax ) were evaluated. Peak oxygen consumption (VO2max ), metabolic equivalents (METs), and maximal heart rate were measured with cardiopulmonary exercise test. Functional capacity and quality of life were assessed with 6-min walk distance and Pediatric Quality of Life Inventory 3.0 Arthritis Module. All participants were evaluated at baseline and post-treatment. RESULTS: FVC ( ↑ 0.20 (95% CI: 0.07/0.32) liters), FEV1 ( ↑ 0.14 (95% CI: 0.02/0.25) liters), PImax (↑19.11 (95% CI: 9.52/28.71) cmH2 O), PEmax (↑12.41 (95% CI: 3.09/21.72) cmH2 O), VO2peak (↑158.29 (95% CI: 63.85/252.73) ml/min), and METs (↑0.92 (95% CI: 0.34/1.49) [ml/kg/min]) significantly improved only in the exercise group (p < .05). The difference over time in FVC, FEV1 , PImax , VO2peak , and METs were significantly higher in exercise group compared to control group (p < .05). CONCLUSIONS: IMT seems to be an effective option for improving respiratory functions and aerobic exercise capacity in JIA.

The Effects of 2 Different Soft Tissue Mobilization Techniques on Delayed Onset Muscle Soreness in Male Recreational Athletes: A Single-Blinded Randomized Controlled Trial.

CONTEXT: Soft tissue mobilization is frequently employed for delayed onset muscle soreness (DOMS) management. Foam roller and percussive massage are 2 popular soft tissue mobilization methods preferred by various professionals. However, their effects on DOMS symptoms are controversial and there are no studies comparing these 2 methods. The aim of the present study was to compare the acute effects of soft tissue mobilization with a foam roller or a percussive massage device on DOMS in young male recreational athletes. DESIGN: A parallel, single-blinded, randomized controlled trial. METHODS: Thirty-six participants (median [interquartile range 25/75]; age: 20.0 [19.3/21.0] y) were randomly allocated to percussive massage group (n = 12), foam roller group (n = 12), and control group (n = 12). First, a fatigue protocol targeting quadriceps femoris was performed. Then, participants received soft tissue mobilization with foam roller/percussive massage or rested for 10 minutes according to their groups. Pain and fatigue were evaluated by a visual analog scale, and the skin surface temperature of over the quadriceps femoris was measured with thermal camera imaging. Evaluations were performed at baseline, following fatigue protocol, at 24th hour, and at 48th hour. Changes from the baseline at 24th and 48th hours were compared between groups. RESULTS: No significant between-group differences were observed at the assessments performed at 24th or 48th hour regarding the changes from baseline in pain (P value for 24th hour = .905, P value for 48th hour = .733), fatigue (P value for 24th hour = .895, P value for 48th hour = .606), or skin surface temperature measurements (P values for 24th hour = between .300 and .925, P values for 48th hour = between .311 and .750). CONCLUSIONS: Soft tissue mobilizations applied with foam roller or percussive massage device do not seem to be superior to passive resting in alleviating DOMS symptoms in recreational athletes.

Assessing fatigue and related factors in adolescents with familial Mediterranean fever (FMF): psychometric properties of the PedsQL Multidimensional Fatigue Scale.

BACKGROUND: Fatigue is a common problem in pediatric rheumatic diseases and is associated with poor quality of life. However, no validated methods are available to measure fatigue in adolescents with familial Mediterranean fever (FMF). The aim of the study was to establish validity and reliability for the child self-report PedsQL Multidimensional Fatigue Scale (PedsQL-MFS) and to investigate the effects of physical characteristics, diseaserelated characteristics, sleep quality/duration, and the amount of physical activity on fatigue in adolescents with FMF. METHODS: Seventy-one adolescents with FMF (13-18 years) were included. Children were examined regarding physical- and disease-related characteristics and completed patient-reported outcome measures (PROMs) regarding sleep quality/duration, physical activity levels, and fatigue. PedsQL-MFS was re-completed within the following 7-14 days. RESULTS: PedsQL-MFS demonstrated excellent test-retest reliability (ICC in 95% CI: 0.877-0.958) and internal consistency (Cronbach`s α: 0.928). All items contributed to the total score (item-total correlation > 0.3). PedsQLMFS scores were significantly correlated to fatigue (r: -0.666, p < 0.001), physical activity (r: 0.373, p < 0.001), sleep quality (rs: 0.678, p < 0.001), and sleep duration (r: 0.473, p < 0.001). Being female, having attacks in the last six months, a sleep duration of less than seven hours, and engaging in less physical activity resulted in higher fatigue. CONCLUSIONS: PedsQL-MFS seems to be feasible for assessing fatigue in adolescents with FMF. Sex, recent attacks, sleep, and physical activity should be taken into consideration in the fatigue management of patients with FMF.

Systemic Sclerosis Quality of Life Questionnaire (SScQoL): translation into Turkish and assessing its psychometric properties.

BACKGROUND: Systemic sclerosis (SSc) is a chronic autoimmune disease that affects the connective tissues and leads to physical, emotional, and social challenges for patients. Evaluating health-related quality of life (HRQoL) with a disease-specific tool may be preferable for improving patient care and treatment outcomes. The aim of this study was to translate the Systemic Sclerosis Quality of Life Questionnaire (SScQoL) into Turkish and to investigate its psychometric properties. METHODS: Eighty-six patients with SSc (mean age 51.8 ± 11.7 years, 80 females) participated in the study. Convergent validity was explored by correlation analyses between Turkish SScQoL and Short-Form 36 (SF-36), European Quality of Life Survey-5 Dimensions (EQ-5D), EQ-5D Visual Analog Scale (EQ-VAS), and Scleroderma Health Assessment Questionnaire (SHAQ). Cronbach's alpha was calculated to test internal consistency. Turkish SScQoL was readministered after 7-14 days to fifty-eight patients for determining test re-test reliability. Intraclass correlation coefficients in 95% confidence interval (ICCs [95%CI]) were calculated to examine the agreement between two assessments. Values greater than 15% and an absolute skewness value < 1 were recognized as the presence of a floor or ceiling effect. RESULTS: SScQoL correlated significantly with SF-36 subdomains (r = -0.347 to -0.618, p < 0.01), EQ-5D (r = -0.535, p < 0.01), EQ-VAS (r = -0.636, p < 0.01), and SHAQ global score (r = 0.521, p < 0.01). SScQoL demonstrated excellent internal consistency (Cronbach's alpha = 0.917), and good to excellent test-retest reliability (ICC [95%CI] = 0.85 [0.76-0.91]). No floor/ceiling effects were observed. CONCLUSION: The Turkish version of SScQoL seems to have adequate psychometric properties and can be used to evaluate HRQoL in clinical and research settings. Key points • Turkish version of SScQoL is a valid and reliable tool for measuring health-related quality of life of patients with systemic sclerosis. • SScQoL is the only diseases-specific quality of life measurement for systemic sclerosis available in Turkish. • Patients with limited and diffuse SSc seem to be similar in terms of self-reported health-related quality of life.

Assessing dyspnea-related kinesiophobia in patients with systemic sclerosis (SSc): validity and reliability of Turkish Breathlessness Beliefs Questionnaire for SSc.

INTRODUCTION/OBJECTIVE: The respiratory system is often affected by systemic sclerosis (SSc), a connective tissue disease characterized by fibrosis, vasculopathy, and inflammation. As a result, especially exertional dyspnea may occur in SSc patients. Evaluation of attitudes towards dyspnea is important in terms of preventing negative consequences such as kinesiophobia. However, no validated tool is available for assessing dyspnea-related kinesiophobia for patients with SSc. The aim of the present study was to perform the Turkish validation of the Breathlessness Beliefs Questionnaire for SSc (BBQ-SSc), which was adapted from the Tampa Kinesiophobia Scale, and to investigate its relationships with physical and clinical characteristics. METHOD: Fifty patients with SSc (47 females) were included in the study. The patients were evaluated regarding pulmonary function tests, respiratory muscle strength, patient-reported dyspnea, quality of life related to respiratory problems, mood, and fatigue. The patients were re-evaluated 1 week later for the test-retest reliability of the BBQ-SSc. RESULTS: Internal consistency (Cronbach's alpha: 0.862) and test-retest validity (ICC: 0.831; 95% CI: 0.702-0.907) of the 12-item Turkish BBQ-SSc were found to be good. Principal component analysis confirmed the two-dimensional structure of the questionnaire. The scores of the questionnaire were associated with duration of illness, patient-reported dyspnea, quality of life related to respiratory problems, mood, and fatigue (p < 0.05). CONCLUSIONS: According to our results, the 12-item Turkish BBQ-SSc is a reliable and valid tool to assess dyspnea-related kinesiophobia in SSc patients. Key Points • There are no structured tools available for assessing dyspnea-related kinesiophobia in patients with systemic sclerosis (SSc) • The 12-item Turkish Breathlessness Beliefs Questionnaire for SSc (BBQ-SSc) is a reliable and valid tool to assess dyspnea-related kinesiophobia in SSc patients.

Investigating performance-based hand functions in patients with systemic sclerosis.

OBJECTIVE: Systemic sclerosis (SSc) is a connective tissue disorder characterized by collagen deposits in various organs. Skin involvement is one of the most common symptoms and along with vascular damage, may deteriorate hand functions. However, the status of hand functions has generally been investigated using patient-reported measures in patients with SSc. The aim of the present study was to investigate performance-based hand functions in patients with SSc using the Sollerman Hand Function Test (SHFT). METHODS: A total of 39 patients with SSc (33 females) were included in the study. Twenty-four patients were classified as limited cutaneous SSc (lcSSc), while 15 patients were classified as diffuse cutaneous SSc (dcSSc). Hand-related physical characteristics were evaluated using the Modified Hand Mobility in Scleroderma Test, grip strength, and pinch strengths. The Duruoz Hand Index (Cochin Hand Functional Disability Scale), Disability of Arm, Shoulder, and Hand Questionnaire, Health Assessment Questionnaire, and Scleroderma Health Assessment Questionnaire were used as patient-reported measures. Performance-based hand functions were evaluated using SHFT. RESULTS: No significant differences were observed between lcSSc and dcSSc subtypes regarding performance-based and patient-reported hand functions (p > 0.05). SHFT scores significantly correlated with hand-related physical characteristics and patient-reported hand functions (p < 0.05). The highest correlation was determined between SHFT and the Duruoz Hand Index (rho: -0.652, p < 0.001). CONCLUSION: According to our results, performance-based hand functions seem not to be affected by disease subtype. Performance-based hand functions may partially be captured by the patient-reported outcomes, especially the Duruoz Hand Index, in patients with SSc.

The effects of Pilates training on respiratory muscle strength in patients with ankylosing spondylitis.

BACKGROUND: Reduction in flexibility and mobility are important factors that lead to impairments in quality of life, reduction of exercise tolerance, and a decreased pulmonary capacity with the progression of Ankylosing Spondylitis (AS). AIM: The purpose of this study was to investigate the effects of Pilates exercises on mobility, quality of life, and respiratory muscle strength in patients with AS. METHODS: Forty patients with AS were randomly divided into two groups as Pilates group and the control group. The Pilates group performed Pilates exercises in supervised group sessions and the control group performed conventional exercises at home three days a week for eight weeks. The main outcome measure was respiratory muscle strength. Secondary outcome measures were forced vital capacity (FVC), forced expiratory volume in one second (FEV1) FEV1/FVC ratio, chest expansion, Bath indices (BASDAI, BASMI), Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) and six-minute walk test (6MWT). All participants were assessed by a blind assessor at baseline and the end of eight weeks. RESULTS: Thirty-six AS patients (n = 19 in the Pilates group, n = 17 in the control group) completed the study. Respiratory muscle strength, FEV1/FVC, chest expansion, BASDAI, BASMI, ASQoL, and 6MWT significantly improved at the 8th week (p < .05) in the Pilates group, while inspiratory muscle strength, FEV1/FVC, chest expansion, and 6MWT showed significant improvements in the control group at 8th week compared to baseline (p < .05). No significant between-group differences were observed when the change over time values were compared (Δ). CONCLUSION: Both Pilates and home exercises seem to be effective for improving respiratory parameters and functional status in patients with AS. Pilates exercises without using any equipment and additional exercises is found to be useful for improving respiratory functions and disease-related symptoms.

Validity and reliability of performance tests as balance measures in patients with total knee arthroplasty.

PURPOSE: This study aimed to investigate validity and reliability of the Timed Up and Go Test (TUG), 10 Meter Walk Test (10MWT), Single Leg Stance Test (SLST), 2 Minute Walk Test (2MWT), and Five Times Sit-to-Stand Test (5xSST) for evaluating balance in patients with total knee arthroplasty (TKA). MATERIALS AND METHODS: This cross-sectional study included 41 participants who had undergone TKA 6 months before the study due to osteoarthritis. Participants performed the TUG, 10MWT, SLST, 5xSST, and 2MWT. Each of the tests was performed twice, with a 1-day interval between tests. Intraclass correlation coefficient (ICC) models were used to determine the test-retest reliability. The level of correlations between performance tests and Berg Balance Scale and Fall Efficacy Scale-International were used to establish concurrent and convergent validity of the performance tests, respectively. RESULTS: The mean age of the subjects was 64.07 ± 10.57 years. All tests showed excellent reliability (ICC > 0.94), excluding SLST that demonstrated good test-retest reliability (ICC = 0.72). All of the tests (SLST, 10MWT, 5xSST, 2MWT, TUG) were found to have good validity (rho > 0.704). CONCLUSIONS: According to these results, TUG, 10MWT, SLST, 5xSST, and 2MWT are reliable and valid outcome measures in patients with TKA, and could be used to assess balance after TKA surgery.

Test-retest reliability and validity of the 6 minute stepper test to evaluate functional exercise capacity in patients with ankylosing spondylitis.

OBJECTIVES: The 6-minute stepper test (6MST) is a submaximal test that requires little space to assess exercise capacity compared to the 6-minute walk test (6MWT). The study aims to investigate the test-retest reliability and convergent validity of 6MST and to compare physiological responses, dyspnea, fatigue perception with 6MST and 6MWT in patients with ankylosing spondylitis (AS). METHODS: To test the convergent validity of 6MST, 65 patients performed both 6MWT and 6MST on the first day and correlation between two tests were assessed with Pearson correlation test. In order to investigate the test-retest reliability of the 6MST, 32 of the 65 patients performed 6MST one week later and intraclass correlation coefficients (ICC) were calculated. Dyspnea and fatigue perception were analyzed with using Wilcoxon signed-rank test, physiological responses were analyzed using paired sample t-test. RESULTS: Excellent test-retest reliability was observed for 6MST (ICC: 0.988). There was a significant correlation between 6MST and 6MWT (r: 0.725, p < 0.001). Dyspnea and leg fatigue perception were significantly higher in 6MST (p < 0.05). Physiological responses and fatigue perception were similar in both 6MST and 6MWT (p > 0.05). CONCLUSION: This study demonstrated that the 6MST is reliable and valid method to evaluate exercise capacity in patients with AS. 6MST can be used to evaluate exercise capacity of patients with AS.

Association of Core Muscle Endurance Times With Balance, Fatigue, Physical Activity Level, and Kyphosis Angle in Patients With Ankylosing Spondylitis.

BACKGROUND/OBJECTIVE: Core muscle endurance (CME), which is the ability of sustaining the activity of trunk muscles, has been shown to be lower in patients with ankylosing spondylitis (AS). The aim was to investigate the possible relationship between CME times and balance, fatigue, physical activity (PA) level, and thoracic kyphosis angle. METHODS: Fifty-one patients with AS with a mean age of 41.0 years (interquartile range, 25/75 years; 29.0/51.0 years) were included in the study. Core muscle endurance times were assessed by using trunk extension, trunk flexion, and side bridge tests. Overall stability index, anteroposterior stability index, mediolateral stability index, and limits of stability were evaluated with the Biodex Balance System. Fatigue and PA levels were surveyed using Fatigue Severity Scale and International Physical Activity Questionnaire, respectively. Thoracic kyphosis angle was measured by using a digital inclinometer. Additionally, CME times were compared for "high-fatigue" versus "low-fatigue" and as "low PA" versus "moderate/high PA" groups. Spearman correlation coefficients and Mann-Whitney U test were used for statistical analysis. RESULTS: Significant correlations were detected between overall stability index, anteroposterior stability index, Fatigue Severity Scale, International Physical Activity Questionnaire, and all CME tests (p < 0.05) and between mediolateral stability index and side bridge test (p < 0.05). Limits of stability correlated only with side bridge test (p < 0.05). Core muscle endurance significantly differed between high-fatigue and low-fatigue groups (p < 0.05), except trunk flexor test (p > 0.05). No significant differences were observed between low PA and moderate/high PA groups (p > 0.05), except side bridge test (p < 0.05). CONCLUSIONS: Core muscle endurance times seem to be related to PA level, fatigue, and balance but not with thoracic kyphosis angle. Assessing CME in patients with AS might help in planning individualized exercise programs.

Validity and reliability of a smartphone goniometer application for measuring hip range of motions.

BACKGROUND: Mobile applications which are designed to assess the range of motion (ROM) are widely used. OBJECTIVE: The aim of this cross-sectional observational study was to determine the inter-observer and intra-observer reliability of a smartphone application "PT Goniometer" (PTG) and determine the correlation between PTG and universal goniometer (UG) regarding active ROMs of the hip in healthy participants. METHODS: Thirty-four healthy young participants were included in the study. Two physiotherapists performed active hip flexion, abduction, internal rotation and external rotation ROM measurements of dominant legs of the participants by using PTG and UG. Intraclass correlation coefficients (ICC) were calculated to determine the intra-observer and inter-observer reliability. Level of correlations between PTG and UG were used to establish concurrent validity of PTG. RESULTS: The PTG demonstrated excellent inter-observer and intra-observer reliability (ICC > 0.90) for all measured hip movements. The minimum detectable change (MDC95) was ranged from 3.29° to 5.1° for the intra-observer reliability, and from 2.55° to 3.21° for the inter-observer reliability. Additionally, the concurrent validity was found excellent (r = 0.91-0.93). CONCLUSION: The results of the present study suggest that PTG is a valid and reliable mobile technology for measuring hip ROMs.

Investigating the lower extremity-related anaerobic exercise capacity and functional status in adult patients with familial Mediterranean fever.

OBJECTIVES: No studies examined the lower extremity-related anaerobic exercise capacity or functional status in adult patients with FMF. METHODS: Twenty-four patients with FMF (12 males) and 24 age-sex-matched healthy controls (13 males) were included in the study. Lower extremity-related anaerobic exercise capacity was assessed by using Wingate Anaerobic Test. Lower extremity-related functional status was examined by using 9-Step Stair Climb Test, 10-Repetition Chair Stand Test, and Six-Minute Walking Distance. Muscle strength of hip flexors, hip extensors, knee flexors, and knee extensors were evaluated by using a hand-held dynamometer. RESULTS: Patients with FMF had significantly poorer results in all anaerobic exercise capacity parameters and functional status assessments (P < 0.05), except muscle strength measurements (P > 0.05). Both average and peak anaerobic exercise capacities correlated significantly with all muscle strength measurements, 9-Step Stair Climb Test, 10-Repetition Chair Stand Test times, and Six-Minute Walk Distances (P < 0.05) in patients with FMF. CONCLUSION: Lower extremity-related anaerobic exercise capacity and functional status seem to be diminished in adult patients with FMF. Evaluating these parameters may be beneficial for planning more appropriate and individualized treatment regimens such as patient education and exercise counselling for patients with FMF.

Is the international physical activity questionnaire (IPAQ) a valid assessment tool for measuring physical activity of patients with axial spondyloartritis?

BACKGROUND: Determining the level of physical activity (PA) is an essential part of patient evaluation in axial spondylarthritis (axSpA). Subjective and objective methods are both frequently used methods for evaluating PA. Although subjective methods are cost-effective and easy to use, their accuracy for measuring PA is still questionable. OBJECTIVE: To investigate the concurrent criterion validity of a self-reported questionnaire (IPAQ-Short Form) when compared to an accelerometer (Actigraph wGT3X-BT) for measuring PA level in patients with axSpA. DESIGN: Cross-sectional design. METHODS: Fifty-eight patients with axSpA with a median age of 39.0 (IQR 25/75: 30.0/46.0) years were included in the study. An accelerometer (Actigraph wGT3X-BT) was attached to the waist of patients at their first visits and was removed at their second visits, seven days later. Patients were asked to complete the International Physical Activity Questionnaire Short Form (IPAQ) at their second visits. RESULTS: No significant correlations were determined between IPAQ and accelerometer (p > 0.05), except for the moderate PA (rho: 0.367, p < 0.05), and total PA (rho: 0.330, p < 0.05). It was also observed that IPAQ was underestimating energy expenditure for all types of PA. CONCLUSION: IPAQ might not be a valid tool for measuring PA level in patients with axSpA. Disease-specific subjective methods for determining the PA should be developed and validated for those patients.

Decreased exercise capacity, strength, physical activity level and quality of life in adult patients with familial Mediterranean fever

Background: Familial Mediterranean fever (FMF) is a systemic autoinflammatory disease that causes recurrent attacks of fever, polyserositis, arthritis or skin eruptions, resulting in pain in the abdomen, muscles, joints and chest. All of these might lead to a reduction in exercise capacity, muscle strength, physical activity level (PAL) and quality of life (QoL). Therefore, assesment of these parameters are important. The aim of this study was to assess exercise capacity, muscle strength, PAL, and QoL in patients with FMF as compared to controls. Materials and methods: A total of 40 subjects with FMF and 36 healthy control subjects participated in the study. The 6-minute walk test (6MWT) was used to assess exercise capacity. Muscle strength measurements for shoulder flexors, extensors and abductors, hip flexors, extensors and abductors, knee flexors and extensors, and ankle dorsiflexors were evaluated by hand-held dynamometer. PAL was assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). QoL was investigated by Nottingham Health Profile (NHP). Results: Significant differences were found between patients and healthy subjects for 6MWT (p = 0.003), muscle strength of ankle dorsiflexors (p = 0.001), hip flexors (p = 0.047), extensors (p = 0.003) and abductors (p = 0.004), total scores of IPAQ-SF (p = 0.004), and pain (p < 0.001), physical mobility (p < 0.001) and energy level (p = 0.026) subscales of NHP. However, there were no significant differences between groups for the shoulder flexion (p = 0.089), extension (p = 0.440) and abduction (p = 0.232), hand grip strength (p = 0.160) , and knee flexion (p = 0.744) and extension (p = 0.155) muscle strength and emotional reaction (p = 0.088), sleep (p = 0.070) and social isolation (p = 0.086) subsets of NHP. Conclusion: Subjects with FMF demonstrated lower exercise capacity, muscle strength, PAL and QoL than healthy peers. Therefore, it is important to evaluate and improve these parameters in patients with FMF.

Inter-rater reliability of modified hand mobility in scleroderma test.

AIM: Systemic sclerosis (SSc) is a chronic autoimmune disease of unknown etiology characterized by excessive collagen production, endothelial cell injury, microvascular obliteration, cutaneous fibrosis and progressive visceral disease. The hands are frequently involved during the progression of the disease, with symmetrical skin thickening as a prominent feature. Modified hand mobility in scleroderma (mHAMIS) test is a measurement method to assess hand mobility in patients with SSc. Knowing the inter-rater reliability of the instrument is important in order for the results from different examiners to be accurately interpreted. The aim of this study was to test inter-rater reliability of the mHAMIS test. METHOD: Hand mobility for both hands was assessed in 25 female patients with SSc by 2 physiotherapists who have different years of experience. Patients who had flexion contracture in at least 1 finger and undergone hand surgery in the last year due to any injuries, were excluded from the study since hand mobility was prevented. Inter-rater reliability was determined using intra-class correlation coefficients (ICCs). RESULT: The ICCs were excellent between raters for dominant and non-dominant hands. The values were 0.92 and 0.93, respectively. CONCLUSION: The inter-rater reliability of the mHAMIS was found to be excellent. This research contributes to the literature by proving that the test can be used without causing bias in clinical trials.