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Table 7 The classification of clinical trials of rehabilitation robots used in this review

From: A survey on robotic devices for upper limb rehabilitation

Term Description
Category 0 Initial feasibility studies: Trials performed with low number of healthy volunteers, often using the prototype of a device, in order to evaluate its safety and clinical feasibility.
Category I Pilot Consideration-of-Concept studies: Clinical trials aimed at testing device safety, clinical feasibility and potential benefit. They are performed in a small population of subjects suffering from the target disease. There is either no control group in the trial, or healthy subjects are used as control.
Category II Development-of-Concept studies: Clinical studies aiming at verification of device efficacy. Include a standardized description of the intervention, a control group, randomization and blinded outcome assessment.
Category III/IV Demonstration-of-Concept-Studies/Proof-of-Concept studies: Further evaluation of the device efficacy. Similar to category II, however, usually these are multicentered studies with high number of participants.
  1. This classification is based on guidelines provided by Lo [198] and supplemented by Category 0.