Abstract
Background
Chronic immune-mediated neuropathies are clinically heterogeneous and require regular, objective, and multidimensional monitoring to individualize treatment. However, established outcome measures are insufficient regarding measurement quality criteria or functional relevance. Wearables such as data gloves might be helpful, allowing repeated quantification of complex everyday life-relevant motor function of the hand. This proof-of-concept study therefore aimed to evaluate validity and test-retest reliability of a data glove, as well as its ability to identify and monitor patients with hand motor impairment.
Methods
25 patients with chronic inflammatory demyelinating polyneuropathy or multifocal motor neuropathy were followed-up for at time points during maintenance therapy with intravenous immunoglobulin. 14 of them showed clinically relevant hand motor impairment. We examined the patients’ hand function using a data glove which quantifies the range of motion (ROM) of the hand based on three different movement patterns. In addition, clinical outcome parameters (grip strength measurement, MRC Sum Score, INCAT disability score), nerve conduction studies (NCS), and high-resolution ultrasound (HRUS) were performed, and patient-reported outcome measures (PROMs) like the R-ODS were assessed. We calculated correlation coefficients, performed Receiver operating characteristic-, as well as correlation analyses for the glove data and clinical outcome parameters. Longitudinal analyses were based on a Linear Mixed Model.
Results
We found good to excellent test-retest reliability for the ROM in all glove movement patterns (Intraclass correlation coefficients = 0.83–0.94), underlining the ability to capture clinical stability. Moreover, the glove revealed sufficient sensitivity and specificity in recognizing hand motor impairment (area under the curve (AUC): 0.714–0.780) and was superior to NCS and HRUS (AUC: 0.552/0.701). Additionally, the data glove proofed to be a valid tool, as we demonstrated moderate to strong, significant correlations between the glove and established clinical parameters (esp. Vigorimeter), as well as PROMs (esp. R-ODS).
Conclusions
This data glove allowed for a non-invasive assessment of the hand motor function and yielded investigator-independent results that reliably reflected individual functional deficits with relevance to everyday life. Further studies should examine the ability to predict clinically meaningful response to immunomodulatory treatment as well as to support and monitor rehabilitation progress, also including other neurological diseases.