JMIR Publications

ABSTRACT

Background:

Functional rehabilitation is commonly used for patients with chronic ankle instability (CAI). Digital training systems have become increasingly popular in postoperative rehabilitation; however, their effectiveness for CAI patients after modified Brostrom surgery is uncertain.

Objective:

This trial aimed to evaluate whether individually tailored physiotherapeutic ankle-specific training (PAST) delivered via a digital training system is noninferior to conventional face-to-face physiotherapy for CAI patients following modified Brostrom surgery in ChinA two-arm, single-assessor blinded, randomized controlled trial was conducted at Huashan Hospital from January 2022 to January 2024, enrolling 84 patients. Participants were randomly allocated to either the digital training system group (DT group, n=42), receiving a 12-week individualized PAST program via digital system, or the conventional face-to-face training group (PT group, n=42), undergoing standard physiotherapy for 12 weeks. Assessments occurred at baseline, 12 weeks, and 24 weeks postoperatively. Primary outcomes were two subscales of the Foot and Ankle Ability Measure (FAAM). Secondary outcomes included balance tests (Time-in-Balance Test, Foot-Lift Test, Star Excursion Balance Test), functional tests (ankle dorsiflexion range of motion, Side-Hop Test, Figure-8 Hop Test), and quality of life assessed by the FAAM scale. Statistical analyses included inferential statistics and bootstrapping for incremental cost-effectiveness ratio (ICER).a.

Methods:

A two-arm, single-assessor blinded, randomized controlled trial was conducted at Huashan Hospital from January 2022 to January 2024, enrolling 84 patients. Participants were randomly allocated to either the digital training system group (DT group, n=42), receiving a 12-week individualized PAST program via digital system, or the conventional face-to-face training group (PT group, n=42), undergoing standard physiotherapy for 12 weeks. Assessments occurred at baseline, 12 weeks, and 24 weeks postoperatively. Primary outcomes were two subscales of the Foot and Ankle Ability Measure (FAAM). Secondary outcomes included balance tests (Time-in-Balance Test, Foot-Lift Test, Star Excursion Balance Test), functional tests (ankle dorsiflexion range of motion, Side-Hop Test, Figure-8 Hop Test), and quality of life assessed by the FAAM scale. Statistical analyses included inferential statistics and bootstrapping for incremental cost-effectiveness ratio (ICER).

Results:

Baseline demographic and clinical characteristics were similar between groups, except for the Foot-Lift Test. At the 24-week follow-up, the between-group differences for FAAM improvements, adjusted for baseline values, indicated noninferiority with near-zero differences: FAAM-activities of daily living (FAAM-ADL), 0.36 (95% CI: -1.01 to 1.72); FAAM-sport (FAAM-S), 1.67 (95% CI: -0.61 to 3.96). Secondary outcome measures (Time-in-Balance Test, ankle dorsiflexion range of motion, Side-Hop Test) also showed no significant differences. The average intervention costs per patient were lower in the DT group (53,551.36 CNY) compared to the PT group (59,372.04 CNY), with incremental costs of -14,450.57 CNY, leading to ICER values of -16,396.25 for FAAM-ADL and -114,130.78 for FAAM-S.

Conclusions:

Individually tailored PAST delivered via a digital training system is noninferior and more cost-effective compared to conventional face-to-face training, supporting its use as a reliable rehabilitation alternative for CAI patients following modified Brostrom surgery.

Conclusions:

Individually tailored PAST delivered via a digital training system is noninferior and more cost-effective compared to conventional face-to-face training, supporting its use as a reliable rehabilitation alternative for CAI patients following modified Brostrom surgery. Clinical Trial: Chinese Clinical Trial Registry (Number: ChiCTR2300075292)