The purpose of this study was to assess the clinical effect of a mobile application supporting home-based rehabilitation for the patients after arthroscopic rotator cuff repair. The investigators hypothesized the clinical results of the patients using a mobile application (APP) to support the home-based rehabilitation were comparable to the patients receiving the supervised rehabilitation.
This prospective randomized case-control study was approved by the institutional review board of the Kaohsiung Veteran General Hospital (IRB No. KSVGH18-CT12-15) prior to enroll any patients. Patients were recruited if they had a small to medium-sized full-thickness rotator cuff tear or, a Lafosse type II or III subscapularis tear diagnosed and then repaired under shoulder arthroscope. After the surgery, patients were randomized either to the home-based rehabilitation (the home group) or the hospital supervised rehabilitation (the supervised group).
In the home group, patients self-managed rehabilitation exercise without supervision. Rehabilitation were supportive with the APP. Patient could communicate with the physician via the APP. In the supervised group, patients attended one-on-one instructions with therapists and exercised under supervision at hospital.
Patients' characters were recorded. Peri-operative factors associated with rotator cuff healing were assessed. The active ROM (forward elevation, abduction, external and internal rotation), the visual analogue scale (VAS) pain scores, the American shoulder and elbow surgeon shoulder (ASES) scores and the modified Constant scores were recorded pre-operatively and post-operatively 3, 6, 12 and 24 months. The isometric shoulder strength was assessed with the hand-held dynamometer. The compliance of post-operative rehabilitation was evaluated not only from patients' self-reported logs but also by physicians at post-operatively 6, 12 and 24 weeks. Tendon integrity was evaluated with MRI scan at least 6 months after the index surgery. In the pilot study, we found a mean difference of 4 points and a standard deviation of 5.5 points in the modified Constant scores. Power analysis revealed a total sample size of 62 patients (31 patients in each group) would achieve a statistical power of 0.8 with a two-tailed level of 0.05 to detect significant differences. Statistical level of significance was defined as p\<0.05.
patients had a small to medium-sized (less than 3 cm) full-thickness rotator cuff tear or, a Lafosse type II or III subscapularis tear diagnosed and repaired by shoulder arthroscope
patients were willing to consent to post-operative rehabilitation randomization and commit to the two-year clinical follow-up period.
pre-operative shoulder stiffness (defined as passive forward elevation less than 100 degrees and external rotation loss over 50% comparing to the contralateral side)
an intra-operative irreparable cuff tear
a prior ipsilateral shoulder surgery
a history of systemic auto-immune disease or septic arthritis of the ipsilateral shoulder
Parallel
Home-based rehabilitation supporting with the mobile application
BehavioralFor patients with mobile application supportive rehabilitation, patients managed rehabilitation exercise by themselves after the surgery without supervision. Rehabilitation protocol and exercise instruction video were available in the application. Patient could communicate with the physician and therapist via the application.
Supervised rehabilitation by the therapist
BehavioralFor patients with therapist supervised rehabilitation, patients attended one-on-one instructions with a therapist (once a week at post-operative 2nd\~12th week and once two weeks at post-operative 13th\~24th week; totally 16 sessions in the 6-month rehabilitation program) and exercised under supervision at hospital. Subjects would receive additional sessions based on the rehabilitation progress. Subjects could cancel scheduled sessions by personal reasons. We provided telephone consultation without APP communication for subjects in the supervised group.
The modified Constant scores
The Constant scores (the total score - 100 maximal points) included both physical examination findings of motion and strength (65 points) and patient-reported subjective evaluation of shoulder function (35 points) to analyze the function of normal and diseased shoulders. The scale consisted of several sections: pain (15 points), patient-reported function with activities of daily living (20 points), range of motion (40 points), and strength testing (25 points). Finally, the scores was normalized to the age and sex of the subject as the modified Constant scores. A higher score indicates better shoulder function.
The modified Constant scores
The Constant scores (the total score - 100 maximal points) included both physical examination findings of motion and strength (65 points) and patient-reported subjective evaluation of shoulder function (35 points) to analyze the function of normal and diseased shoulders. The scale consisted of several sections: pain (15 points), patient-reported function with activities of daily living (20 points), range of motion (40 points), and strength testing (25 points). Finally, the scores was normalized to the age and sex of the subject as the modified Constant scores. A higher score indicates better shoulder function.
The American shoulder and elbow surgeon shoulder (ASES) scores
The ASES score contains a physician-rated and patient-rated section. The pain visual analog scale (VAS) and 10 functional questions are used to tabulate the reported ASES score. The total score - 100 maximum points - is weighted 50% for pain and 50% for function. The pain score (maximum 50 points) is calculated by subtracting the VAS from 10 and multiplying by five. The functional score is calculated from 10 questions(a scale from 0 to 3) for a maximal score of 50 points. The pain and functional portions are then summed to obtain the final ASES score. A higher score represent better function.
The American shoulder and elbow surgeon shoulder (ASES) scores
The ASES score contains a physician-rated and patient-rated section. The pain visual analog scale (VAS) and 10 functional questions are used to tabulate the reported ASES score. The total score - 100 maximum points - is weighted 50% for pain and 50% for function. The pain score (maximum 50 points) is calculated by subtracting the VAS from 10 and multiplying by five. The functional score is calculated from 10 questions(a scale from 0 to 3) for a maximal score of 50 points. The pain and functional portions are then summed to obtain the final ASES score. A higher score represent better function.
The degree of active range of motion (ROM) of shoulder joint
Regarding evaluation of the degree of active shoulder ROM, the angle for forward flexion, abduction, external rotation with the arm at the side was measured with a goniometer. Internal rotation was recorded by the maximal height achieved with the ipsilateral thumb when attempting to reach behind the back (ipsilateral thumb to the point of anatomic landmarks：0 points=lateral aspect of thigh, 2 points=behind buttock, 4 points=sacroiliac joint, 6 points=waist, 8 points=12th thoracic vertebrae, 10 points=inter-scapular level).
The degree of active range of motion (ROM) of shoulder joint
Regarding evaluation of the degree of active shoulder ROM, the angle for forward flexion, abduction, external rotation with the arm at the side was measured with a goniometer. Internal rotation was recorded by the maximal height achieved with the ipsilateral thumb when attempting to reach behind the back (ipsilateral thumb to the point of anatomic landmarks：0 points=lateral aspect of thigh, 2 points=behind buttock, 4 points=sacroiliac joint, 6 points=waist, 8 points=12th thoracic vertebrae, 10 points=inter-scapular level).
The grade of compliance of post-operative rehabilitation
The compliance of post-operative rehabilitation was evaluated not only from patients' self-reported logs but also by physicians at post-operatively 6 weeks. For patients, the log recorded the grade of home-exercise frequency as "high" (exercise 5-7 days per week), "intermediate" (exercise 2-4 days per week) and "low" (exercise 0-1 day per week). In the clinics, physicians questioned patients about the rehab-principle, activity, and frequency to assess of the compliance of doing home-exercise in three grades (high, intermediate, and low).
The grade of compliance of post-operative rehabilitation
The compliance of post-operative rehabilitation was evaluated not only from patients' self-reported logs but also by physicians at post-operatively 12 weeks. For patients, the log recorded the grade of home-exercise frequency as "high" (exercise 5-7 days per week), "intermediate" (exercise 2-4 days per week) and "low" (exercise 0-1 day per week). In the clinics, physicians questioned patients about the rehab-principle, activity, and frequency to assess of the compliance of doing home-exercise in three grades (high, intermediate, and low).
The grade of compliance of post-operative rehabilitation
The compliance of post-operative rehabilitation was evaluated not only from patients' self-reported logs but also by physicians at post-operatively 24 weeks. For patients, the log recorded the grade of home-exercise frequency as "high" (exercise 5-7 days per week), "intermediate" (exercise 2-4 days per week) and "low" (exercise 0-1 day per week). In the clinics, physicians questioned patients about the rehab-principle, activity, and frequency to assess of the compliance of doing home-exercise in three grades (high, intermediate, and low).
Click on the lead sponsor to view all of their trials.
