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