## 2 Protocol Description
### Deployment and Clinical Validation  
This phase covers the actual hardware and software deployment, and all the tasks leading to the clinical validation process. The associated flowchart is shown in Figure 3.  
Figure 4: Algorithmic system modules for automatic human functional assessment in the EYEFUL system. Figure 3: Protocol flowchart: algorithmic development and technical validation (Section 2.7) and deployment and clinical validation (Section 2.8). The system deployment in the assessment space will be the responsibility of the engineering group. They will install and configure the sensor, communication, and processing equipment in the space where the people will carry out the selected ADLs, and to verify its correct functioning. Once the hardware is deployed and verified, a full installation of all the integrated algorithmic modules will be performed, also checking their correct operation. A user control interface will be designed and implemented. It is necessary to integrate all the information from the different sensors in a single interface, which allows the handling by the clinical staff during the recording and data capture phases, and also during the assessment system operation. The clinicians will specify how they want the user control interface, and the engineers will make the necessary modifications. To carry out the clinical validation process of the system following this protocol, it is necessary to have cohorts of people with different characteristics. In the case of the EYEFUL system, we will require people with and without dependence. The inclusion criteria for the group of people without dependence, who will form the control group, are as follows:  
1. Be over 18 years of age. 2. Have no recognized degree of dependence. 3. Accept and sign the informed consent form. The inclusion criteria for the group of people with dependence, who will form the experimental group, are the following:  
1. To be over 18 years of age. 2. To have a recognized degree of dependence (from degree I, level 1 to degree II, level 2). 3. To be able to walk independently, with or without support products (canes, crutches, walkers, etc.) 4. To accept and sign the informed consent form. Exclusion criteria for the study are specified as:  
1. Having a cognitive, physical, or sensory deficit that impedes the understanding of questionnaires or the performance of the tests. 2. Wheelchair users. A sample of the control group will be required for the training of the system. The control group will be obtained by proximity to the research team and the university environment, for convenience and for matching purposes. All subjects will be informed and must sign the informed consent form approved by the Ethics Committee before participating in the study. This phase also includes the recordings for the users of both the control and dependence groups, which implies intensive work in users' recruitment, recording sessions scheduling, and labeling. The labeling process is a specialized task that requires the use of specific annotation applications and will be carried out by the occupational therapy group, as they specialize in administering standardized observational tests that assess functional limitation. It is a time-consuming task, but it is crucial in the training and evaluation phase of the systems from a technical standpoint and in the final clinical validation. We have identified the ELAN annotation application [33] as a suitable tool for this task, as it allows the temporal labeling of multimedia sequences (specifically audio and video streams), that can be applied to any system within this protocol scope. Once the verification, analytical validation and technical validation of the data generated by the system have been completed, the clinical validation will be carried out, i.e., it will be demonstrated whether the system acceptably identifies, measures, or predicts the level of dependence.