Co-Designed Digital Device for Tracking Rehabilitation Dosage in a Clinical Environment After Stroke: Mixed Methods Validity and Feasibility Study.

Abstract

Background: In 2023, the National Clinical Guidelines for Stroke revised the recommended daily multidisciplinary therapy dose from 45 minutes per therapy to 3 hours of therapy overall. To monitor the achievement of these guidelines, there is a need for accurate measurement. This study introduces a novel co-designed digital dosage tracking system that uses Near Field Communication technology to log rehabilitation activities and demonstrates its feasibility and accuracy in a clinical setting through comparison with the current clinical method of manual recording.

Objective: This study aimed to assess the validity, feasibility, and usability of a novel co-designed digital tracker using Near Field Communication technology to automatically log rehabilitation dosage in people with stroke history, providing an objective and low-burden solution for clinical environments.

Methods: This pilot mixed methods study included 2 phases. Phase 1 involved a usability trial with 9 participants conducted at a university research center, assessing usability with the System Usability Scale (SUS) and Intrinsic Motivation Inventory (IMI). Phase 2 consisted of a clinical trial in a National Health Service stroke ward with 15 inpatients, comparing the digital tracker with manual therapist recordings for validity and feasibility using paired t tests, Cohen d, and Bland-Altman plots. An acceptable discrepancy range was set at ±5%-10%.

Results: The digital tracker demonstrated high usability with a mean SUS score of 91.43 (SD 9.53) and strong user satisfaction (IMI score 6.29/7, SD 1.50). Clinical trial results showed a strong agreement between the digital and manual methods (t206=-1.60; P=.11; Cohen d=-0.06), with a small mean time discrepancy of 1.23 (SD 11.01) minutes across 207 activities. The Bland-Altman plot indicated good accuracy and consistency between methods, with limits of agreement within the clinically acceptable range.

Conclusions: The co-designed digital tracker has been shown to agree with a manual method for recording rehabilitation dosage. This development presents the opportunity for objective, automated, and low-burden recording of rehabilitation dose to support prescription, monitoring, and research.