The Effect of Self-rehabilitation Using Communication APP After Arthroscopic Surgery for Rotator Cuff Tear
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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