The Effect of Self-rehabilitation Using Communication APP After Arthroscopic Surgery for Rotator Cuff Tear

Sponsor
Kaohsiung Veterans General Hospital.
Study ID
NCT05102968
Status
Recruiting
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Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Home-based rehabilitation supporting with the mobile application — BEHAVIORAL
    For 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 — BEHAVIORAL
    For 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.

Study Details

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.

Key Dates

First listed
Nov 2, 2021
Start date
Mar 22, 2019
Status verified
Oct 2021
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rehabilitation with mobile application
    Patients self-managed rehab exercise with a supportive mobile application
  • Active Comparator: Rehabilitation under supervision
    Patients received supervised physical therapy

Primary Outcome Measure

The modified Constant scores [ Time Frame: post-op 6 months ]

Central Contacts

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