Development of a single device to quantify motor impairments of the elbow: proof of concept.

BACKGROUND: For patients with post-stroke upper limb impairments, the currently available clinical measurement instruments are inadequate for reliable quantification of multiple impairments, such as muscle weakness, abnormal synergy, changes in elastic joint properties and spasticity. Robotic devices to date have successfully achieved precise and accurate quantification but are often limited to the measurement of one or two impairments. Our primary aim is to develop a robotic device that can effectively quantify four main motor impairments of the elbow. METHODS: The robotic device, Shoulder Elbow Perturbator, is a one-degree-of-freedom device that can simultaneously manipulate the elbow joint and support the (partial) weight of the human arm. Upper limb impairments of the elbow were quantified based on four experiments on the paretic arm in ten stroke patients (mean age 65 ± 10 yrs, 9 males, post-stroke) and the non-dominant arm in 20 healthy controls (mean age 65 ± 14 yrs, 6 males). The maximum strength of elbow flexor and elbow extensor muscles was measured isometrically at 90-degree elbow flexion. The maximal active extension angle of the elbow was measured under different arm weight support levels to assess abnormal synergy. Torque resistance was analyzed during a slow (6°/s) passive elbow rotation, where the elbow moved from the maximal flexion to maximal extension angle and back, to assess elastic joint properties. The torque profile was evaluated during fast (100°/s) passive extension rotation of the elbow to estimate spasticity. RESULTS: The ten chronic stroke patients successfully completed the measurement protocol. The results showed impairment values outside the 10th and 90th percentile reference intervals of healthy controls. Individual patient profiles were determined and illustrated in a radar figure, to support clinicians in developing targeted treatment plans. CONCLUSION: The Shoulder Elbow Perturbator can effectively quantify the four most important impairments of the elbow in stroke patients and distinguish impairment scores of patients from healthy controls. These results are promising for objective and complete quantification of motor impairments of the elbow and monitoring patient prognosis. Our newly developed Shoulder Elbow Perturbator can therefore in the future be employed to evaluate treatment effects by comparing pre- and post-treatment assessments.

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.