Improving patient outcomes in acute and subacute stroke using a wearable device-assisted rehabilitation system: a randomized controlled trial.

Objective: Multidisciplinary rehabilitation facilitates post-stroke functional recovery, but is associated with resource and accessibility barriers. This study evaluated the combination of a wearable device-assisted system (WEAR) and conventional therapy for post-stroke rehabilitation.

Methods: This randomized, controlled, parallel group, clinical trial was conducted at two rehabilitation centers. A WEAR system was developed featuring sensors and application program-embedded smartphones. Stroke patients within 12 weeks of onset and modified Rankin Scale (mRS) scores of 2 to 4 were randomized into a wearable group (WG, WEAR + conventional rehabilitation) or control group (CG, conventional rehabilitation) for 90 days. The primary outcome was mRS score changes within 90 days.

Results: Among 127 stroke patients enrolled (76 men [59.8%]; mean age: 57.5 years), 63 and 64 patients were randomized to WG and CG, respectively. Both groups showed significant improvements in mRS scores. Between-group repeated measures analysis adjusted for sex, age and number of rehabilitation sessions showed greater improvement in mRS scores within 90 days in the WG than in the CG (estimate: 0.73).

Conclusions: This combined WEAR and conventional rehabilitation approach may improve post-stroke functional recovery compared with conventional rehabilitation alone. The WEAR system permits remote monitoring and recording of rehabilitation in various settings.This clinical trial was retrospectively registered at www.clinicaltrials.gov with the Unique Identifier NCT04997408.