Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation

This outcome measure is designed to systematically document and analyze any malfunctions of the DESC-Glove device throughout the study. All malfunctions will be recorded in detail, including the frequency and type of malfunction. Each issue will be categorized based on the nature of the malfunction, such as hardware failures (e.g., sensor or vibration issues), software, or connectivity problems. This data will be used to assess the overall reliability and functionality of the device, guiding future improvements and treatment efficacy.

This outcome measure aims to document the number of participants who withdraw from the study specifically due to issues related to the device.

The Box and Blocks Test is a clinical assessment used to measure manual dexterity and upper limb function. During the test, participants transfer as many small blocks as possible from one compartment of a box to another within 60 seconds. The score is based on the number of blocks successfully moved, reflecting hand coordination and fine motor skills. The test is conducted under three conditions: (a) with the DESC-Glove providing vibratory feedback, (b) with the DESC-Glove not providing vibrations, and (c) without the DESC-Glove altogether

The Frenchay Arm Test (FAT) is an assessment tool designed to measure upper extremity proximal motor control and dexterity during activities of daily living (ADL) in patients with neurological impairments. It focuses on evaluating activity limitations specific to the upper extremities. Each of the test's five items is scored as either a pass (1) or fail (0), with total scores ranging from 0 to 5.

The Thumb Localizing Test is an assessment used to evaluate proprioception and sensory awareness in the hand. During the test, the examiner places the participant's thumb in various positions, either passively or with minimal resistance, while the participant's eyes are closed. The participant is then asked to replicate the position of their thumb with their opposite hand or to indicate the position of their thumb using verbal or tactile cues. It ranges from 0 (normal) to 3 (severely impaired).

The 5-level EQ-5D is a standardized instrument used to measure health-related quality of life. It consists of a descriptive system and a visual analogue scale (VAS). The descriptive system evaluates five dimensions of health - mobility, self-care, usual activities, pain/discomfort and anxiety/depression - each with five levels of severity. The result is calculated by assigning a numerical value to each response level and summing these values across the five items.

The Pick and Lift Test (PLT) assesses the ability of participants to lift a sensorized object using a bi-digit grip with their thumb and index finger. During the test, participants repeatedly lift the object while the levels of force applied during the manipulation tasks are recorded. The PLT is conducted under three conditions: (a) with the DESC-Glove providing vibratory feedback, (b) with the DESC-Glove not providing vibrations, and (c) without the DESC-Glove altogether. This design allows for an evaluation of the impact of vibratory feedback on force application and manipulation skills.

Such a system is not intended as a clinical validation tool but rather as a means of data acquisition to extract metrics considered standard in the scientific literature regarding motor coordination in manipulation.

The Pick and Place Test (PPT) with a fragile object involves performing a series of movements to transfer a fragile item from one side of a barrier to the other. This object walls collapse when the gripping force applied to these walls exceeds a certain threshold. It measures the participant's ability to regulate grip strength and dexterity.

Such a system is not intended as a clinical validation tool but rather as a means of data acquisition to extract metrics considered standard in the scientific literature regarding motor coordination in manipulation.

The system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability. A SUS score can range from 0 to 100, with higher scores indicating better usability. This questionnaire will be evaluated exclusively within the experimental group.

The Gradibility Questionnaire has been specifically designed to provide a thorough assessment of user experiences. It consists of 13 items that evaluate the usability, acceptability, and satisfaction of users testing the device. This questionnaire will be evaluated exclusively within the experimental group.

The Technology Acceptance Model is designed to identify the determinants influencing the acceptance of Robotic and Allied Technology. It comprises four sections: perceived usefulness, ease of use, compatibility, and intention to use. Each question utilizes a 7-point Likert scale, ranging from 1 (worst) to 7 (best). The scoring for each section is calculated as the average of the responses, with scores ranging from 1 (worst) to 7 (best). This questionnaire will be evaluated exclusively within the experimental group.