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. |