Home-Based Digital Exercise Program for Patients After Open Repair of Acute Achilles Tendon Rupture: Noninferiority Randomized Controlled Trial.

Background: Achilles tendon rupture significantly affects patient mobility and quality of life. Postoperative rehabilitation is critical to regain ankle function, strength, and return to activity. Home-based digital rehabilitation has emerged as an accessible alternative to traditional clinic-based physiotherapy; however, high-quality evidence comparing these approaches after Achilles tendon repair remains scarce. Objective: This randomized controlled trial aimed to evaluate whether a home-based digital exercise program (DEP) is noninferior to clinic-based face-to-face physiotherapy for restoring ankle range of motion (ROM), strength, patient-reported outcomes, and cost-effectiveness following open Achilles tendon repair. Methods: Between August 2020 and June 2023, 200 adult patients (mean age 36.5, SD 5.0 years; n=135, 67.5% male) undergoing open Achilles tendon repair at 2 trauma centers were randomly assigned (1:1) to either a 12-week home-based DEP group (n=100) or traditional 12-week clinic-based physiotherapy (CP group, n=100) in Shanghai. The digital program was delivered through an online app, providing instructional videos, real-time telecommunication, daily exercise tasks, and monitoring of adherence. The clinic-based group received weekly physiotherapist-supervised sessions. The primary outcome was ankle ROM at 12 weeks postoperatively. Secondary outcomes included plantarflexion strength at 0° and 12°, heel-rise index and height, Achilles Tendon Total Rupture Score (ATRS), Victorian Institute of Sport Assessment-Achilles scores, adherence, patient satisfaction, cost-effectiveness, and adverse events assessed at 6, 12, and 24 weeks. Mixed-effects models were applied for intention-to-treat analyses, and sensitivity analyses were performed in the per-protocol population. Results: At 12 weeks postoperatively, the DEP group was noninferior to the CP group for ankle ROM: mean difference (DEP-CP=-0.08°) with a 1-sided 95% CI lower bound of -2.16°, exceeding the noninferiority margin of -5° (P<.001). Secondary clinical outcomes at 12 weeks showed no material between-group differences, and after Holm-Bonferroni adjustment for multiplicity across secondary endpoints, no comparison reached statistical significance. Standardized effects at 12 weeks were trivial to small (|Cohen d|≤0.16). Patients rated DEP higher for convenience and ease of access in unadjusted analyses, but these did not remain significant after multiplicity correction (adjusted P=.08). DEP significantly reduced total rehabilitation costs vs CP (CNY 59,260.77 vs 68,432.80), with economic analyses favoring DEP. Adverse events were comparable between groups (DEP: 18, 18% patients and CP: 22, 22% patients; P>.05). The exchange rate used in this study was 1 US $=6.90 Chinese Yuan. Conclusions: The home-based DEP following Achilles tendon repair provided comparable clinical outcomes to traditional physiotherapy while significantly improving cost-effectiveness. These findings support the broader adoption of tele-supervised digital rehabilitation as a safe and effective alternative.