The diagnostic levels of evidence of instrumented devices for measuring viscoelastic joint properties and spasticity: a systematic review

BACKGROUND: Many diagnostic robotic devices have been developed to quantify viscoelastic properties and spasticity of patients with upper motor neuron lesions. However, in clinical practice, subjective and nonvalid clinical scales are still commonly used. To understand the limited use of diagnostic robotic devices assessing viscoelastic joint properties and spasticity in clinical practice, we evaluate the diagnostic level of evidence of studies on these devices. METHOD: A systematic literature review was performed using multiple databases. Two of the authors independently screened all articles. Studies investigating human subjects diagnosed with stroke or cerebral palsy, measured with a mechanical device to assess viscoelastic joint properties and/or spasticity of an extremity. All articles were assigned a diagnostic level of evidence, which was established with a classification strategy based on the number of participants and the design of the study, from a Level 0 (less than 10 subjects) to a Level IV, reporting the long-term clinical consequences in daily care. RESULTS: Fifty-nine articles were included. Most studies measured the upper limb (64%) in stroke patients (81%). The highest level of evidence found was Level IIa (53%); these studies correlated the test values of the robotic device with a clinical test or within subgroups. Level 0 (30%) and Level I (17%; determining the range of values of the robotic test) were also common. None of the studies tested their device for diagnostic accuracy (Level III), clinical added value (Level IV). CONCLUSION: The diagnostic evidence needed for implementing robotic devices in clinical practice is lacking. Our findings indicate that more effort should be invested in studying diagnostic accuracy (Level III) or added value for clinical care (Level IV); only these studies can provide clinicians with evidence that robotic devices have added value above the currently-used clinical scales.