Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair

domain : pain, function

• Pain is measured using a Visual Analog Scale (VAS) rated out of 10 points and then converted to a 50-point scale.
• Function is assessed through a questionnaire consisting of 10 items, each scored from 0 to 3, with a total raw score of 30. This total is converted to a 50-point scale.

This results in a final combined score ranging from 0 to 100, with higher scores indicating better shoulder function.

The scoring system ranges from 0 to 100 points, with higher scores indicating better shoulder function. It includes the following components: pain (15 points), activities of daily living (20 points), active range of motion (ROM) (40 points), and muscle strength (25 points). Muscle strength is measured by assessing force in 90-degree shoulder abduction and then converted into a score.

The scale ranges from 0 to 100 points, with higher scores indicating better function. It is composed of the following components: pain (30 points), function (40 points), activities of daily living (10 points), muscle strength (20 points), and satisfaction (10 points).

The score ranges from 0 to 12 points, with higher scores indicating better function. It is an outcome measure consisting of 12 yes/no questions related to function. Each "yes" response is scored as 1 point, and the total number of "yes" answers is summed to calculate the final score. This tool provides a simple patient-reported outcome to briefly assess the ability to perform daily activities.

Evaluated during rest and activity. Pain is assessed using an 11-point scale (0-10 points) evaluating overall shoulder pain over the past 7 days. A lower score indicates an improvement in pain.

A. Forward flexion (0-180 degrees), abduction (0-180 degrees), and external rotation at the side with the upper arm beside the torso (0-90 degrees) are measured using a goniometer to record the maximum angles. Higher values indicate better shoulder mobility.

B. Internal rotation at the back: When the arm is placed behind the back, the level of the spine reached by the tip of the thumb is measured and scored accordingly (thoracic vertebrae T1-T12 = 1-12 points; lumbar vertebrae L1-L5 = 13-17 points; buttock = 18 points). Higher scores indicate better shoulder mobility.

A. Forward flexion (0-180 degrees), abduction (0-180 degrees), and external rotation at the side with the upper arm beside the torso (0-90 degrees) are measured using a goniometer to record the maximum angles. Higher values indicate better shoulder mobility.

B. Internal rotation at the back: When the arm is placed behind the back, the level of the spine reached by the tip of the thumb is measured and scored accordingly (thoracic vertebrae T1-T12 = 1-12 points; lumbar vertebrae L1-L5 = 13-17 points; buttock = 18 points). Higher scores indicate better shoulder mobility.

Isokinetic muscle strength is measured for each movement following a standardized protocol using an isokinetic dynamometer (HUMAN NORM; exercise testing and evaluation device; classification number A30130.01, Class 2 medical device). During the test, the subject sits on a chair with the trunk fixed to the dynamometer. The subject holds the handle on the opposite side of the dynamometer. Higher values indicate better muscle strength.

Internal and external rotation: The arm is abducted to 45 degrees in the scapular plane with the elbow flexed to 90 degrees. External rotation range of motion is set at 65 degrees and internal rotation at 25 degrees. Measurements are taken at an angular velocity of 60 degrees per second for 4 repetitions (strength) and 180 degrees per second for 10 repetitions (muscular endurance), recording peak torque in pounds.

Using a hand-held dynamometer (FGN-20B, SHIMPO, JAPAN), the maximum force (in pounds) is collected and measured in the internal rotation (at side), external rotation (at side), and scaption positions.

The overall change assessment scale ranges from -5 (much worse) to 5 (much improved) points, evaluating the patient's perception of overall functional recovery and satisfaction with their general condition. Compared to pre-surgery, a change of 2 points or more at the end of intervention (T3), and similarly from T3 to the end of follow-up (T4), is interpreted as the minimum clinically important difference.

The scale consists of 9 items describing situations that hinder exercise. It uses a 0% (not confident at all) to 100% (extremely confident) scale, with intervals of 10%, assessing the patient's confidence in being able to exercise for 20 minutes, three times a week in each situation. Scores are interpreted as follows: 0-20% = not confident at all, 20-40% = slightly confident, 40-60% = moderately confident, 60-80% = very confident, and 80-100% = extremely confident.

The assessment evaluates difficulties experienced over the past 30 days and consists of 36 items covering six core domains: cognition, mobility, self-care, interpersonal relationships, activities of daily living, and social participation. Each item is rated on a 5-point Likert scale from "no difficulty at all (0 points)" to "extreme difficulty or impossible (4 points)." The total score is calculated by summing all domain scores, ranging from 0 to 100 points. Higher scores indicate greater functional difficulty and a higher level of disability, while lower scores represent better function and lower disability.

Health literacy is assessed by measuring the ability to search for, understand, evaluate, and utilize health information. Scores range from a minimum of 8 to a maximum of 40 points, with higher scores indicating better literacy. A score of 24 or below (criteria may vary by study) suggests a high likelihood of difficulty in searching for and using health information on the internet.

It consists of 10 items designed to evaluate the usability of the system, with a score range from 0 to 100. Higher scores indicate that the system is easier and more convenient to use.

A survey is conducted to assess overall mobile app satisfaction, perceived usefulness, perceived ease of use (PEOU), attitude toward using technology, and behavioral intention to use.

A Likert scale (1-5 points) is used, with higher scores interpreted as indicating a greater likelihood of technology acceptance.

This investigates the occurrence and frequency of any additional external treatments the patient received aside from the intervention provided by the institution (including visits to other hospitals, imaging tests, physical therapy, injections/procedures, medications, etc.) and collects perceived benefit scores (0-10 points).

This monitoring helps identify protocol violations and evaluates additional medical and economic burdens between the two groups, potentially revealing cost advantages.