Actively Recruiting
The Effect of Self-rehabilitation Using Communication APP After Arthroscopic Surgery for Rotator Cuff Tear
Led by Kaohsiung Veterans General Hospital. · Updated on 2021-11-02
60
Participants Needed
1
Research Sites
405 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Self-rehabilitation Using Communication APP After Arthroscopic Surgery for Rotator Cuff Tear
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients have a small to medium-sized (less than 3 cm) full-thickness rotator cuff tear or a Lafosse type II or III subscapularis tear repaired by shoulder arthroscopy
- Patients agree to post-operative rehabilitation randomization
- Patients commit to a two-year clinical follow-up period
You will not qualify if you...
- Pre-operative shoulder stiffness defined as passive forward elevation less than 100 degrees and external rotation loss over 50% compared to the opposite side
- Irreparable cuff tear found during surgery
- Previous surgery on the same shoulder
- History of systemic autoimmune disease or septic arthritis of the affected shoulder
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kaohsiung Veterns General Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
Research Team
F
Futing Huang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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