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Digital Physiotherapeutic Ankle-Specific Training System for Patients With Chronic Ankle Instability Following
Xiang Geng1, Yilin Jin1,2, Xu Wang1
1Department of Orthopedic Surgery, Huashan Hospital, Fudan University, No. 12, Middle Wulumuqi Road, Shanghai, 200040, China.
Background:
Functional rehabilitation is commonly used for patients with chronic ankle instability (CAI). Digital training (DT) systems have become increasingly popular in postoperative rehabilitation; however, their effectiveness for CAI patients after modified Brostrom surgery (MBS) is uncertain. Furthermore, specialized physiotherapy resources for CAI are limited in some regions, highlighting the need for effective digital home-based rehabilitation alternatives.
Objective:
This trial aimed to evaluate whether individually tailored physiotherapeutic ankle-specific training (PAST) delivered via a DT system is noninferior to conventional face-to-face physiotherapy in clinical outcomes and to compare their cost-effectiveness in CAI patients following MBS in China.
Methods:
We conducted a 2-arm, single-blinded (assessor), noninferiority randomized controlled trial at a tertiary hospital in Shanghai, China, from January 2022 to January 2024. A total of 84 postsurgery CAI patients were randomly assigned to a DT group (n=42), which received a 12-week individualized PAST program via a digital system, or a physiotherapy group (n=42), which received standard face-to-face physiotherapy for 12 weeks. Assessments were performed at baseline, 12 weeks, and 24 weeks postoperatively. The primary outcomes were 2 subscales of the Foot and Ankle Ability Measure, with a noninferiority margin of 8 points for Foot and Ankle Ability Measure-Activities of Daily Living (FAAM-ADL) and 9 points for Foot and Ankle Ability Measure-Sports (FAAM-S). Secondary outcomes included balance tests (time-in-balance, foot-lift, and star excursion balance), functional tests (ankle dorsiflexion range of motion, side-hop, and figure-8 hop), and quality of life (FAAM questionnaire). We also collected intervention costs to evaluate cost-effectiveness. Statistical analyses included between-group comparisons of outcomes and nonparametric bootstrapping to calculate incremental cost-effectiveness ratios.
Results:
Baseline characteristics were similar between groups (except for a difference in foot-lift test performance). By the 24-week follow-up, improvements in the primary outcomes were comparable between the DT and physiotherapy groups, with adjusted between-group differences of 0.36 (95% CI -1.01 to 1.72) for FAAM-ADL and 1.67 (95% CI -0.61 to 3.96) for FAAM-S. These differences fell within the predefined noninferiority margins, demonstrating noninferiority of the digital program. No significant between-group differences were observed in secondary outcomes (all P>.05). The average cost per patient was lower in the DT group (CNY 53,551; an exchange rate of US $1=CNY 7 was applied) than in the physiotherapy group (CNY 59,372), yielding an incremental cost of CNY -14,451 in favor of the digital intervention. The bootstrapped incremental cost-effectiveness ratios were CNY -16,396 for FAAM-ADL and CNY -114,131 for FAAM-S, indicating that DT was more cost-effective.
Conclusions:
Individually tailored PAST delivered via a DT system was found to be clinically noninferior to conventional face-to-face physiotherapy and more cost-effective, supporting its use as a viable rehabilitation alternative for CAI patients after MBS.
