Home-Based Exergame Motor-Cognitive Rehabilitation for Traumatic Brain Injury

A validated screening tool used to assess global cognitive functioning. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.

A validated neuropsychological test used to assess information processing speed, attention, and visual scanning. Participants are required to match symbols with corresponding numbers according to a reference key within 90 seconds. The score consists of the number of correct symbol-digit pairings completed in 90 seconds, with higher scores indicating better cognitive performance and faster processing speed.

A validated neuropsychological test used to assess verbal learning and memory. A list of words is read aloud over five consecutive trials, and after each presentation participants are asked to freely recall as many words as possible. The score consists of the total number of correctly recalled words across the five learning trials, with higher scores indicating better verbal learning and memory performance.

A validated neuropsychological test used to assess visuospatial learning and memory. Participants are shown a display containing six geometric figures for 10 seconds and are then asked to reproduce them from memory. This procedure is repeated over three learning trials. The score consists of the total number of points obtained across the three recall trials, based on the accuracy and location of the reproduced figures, with higher scores indicating better visuospatial learning and memory performance.

A validated self-report questionnaire used to assess symptoms of anxiety and depression in medical and rehabilitation settings. The scale consists of 14 items, divided into two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D), each comprising 7 items. Scores for each subscale range from 0 to 21, with higher scores indicating greater levels of anxiety or depressive symptoms. The total HADS score ranges from 0 to 42.

A validated clinical scale used to assess functional balance. The assessment consists of 14 functional tasks involving sitting, standing, transfers, reaching, turning, and single-leg stance. Each item is scored from 0 to 4, with a total score ranging from 0 to 56. Higher scores indicate better balance performance. Kinematic data will be recorded by an inertial sensor on lower back.

A validated test used to assess walking capacity and endurance. Participants are instructed to walk as far as possible along a 30-meter corridor for 6 minutes, with rest periods and walking aids allowed if necessary. The outcome measure is the total distance walked in 6 minutes, with greater distances indicating better walking capacity and endurance. Kinematic data will be recorded by three inertial sensors on lower back and feet.

A validated measure of functional mobility and dynamic balance that assesses the time required for a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. The test is administered under both single-task and cognitive dual-task conditions. In the dual-task condition (TUG-DT), participants perform the TUG while simultaneously completing a cognitive task consisting of generating alternating letters of the alphabet during walking. Outcome measures include completion time (seconds), and the Dual-Task Cost (DTC) for motor and cognitive performance, calculated as the percentage change between single-task and dual-task conditions. Lower completion times and lower DTC values indicate better functional mobility and dual-task ability. Kinematic data will be recorded by an inertial sensor on lower back.

A validated self-report measure of health-related quality of life, used for clinical and economic appraisal.

The questionnaire assesses five dimensions of health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity ranging from no problems to extreme problems. Responses are converted into a health utility index score, with higher scores indicating better perceived health status. The instrument also includes a Visual Analogue Scale (EQ VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health), on which participants rate their overall health.

A validated, disease-specific self-report questionnaire designed to assess health-related quality of life in individuals with traumatic brain injury (TBI). The instrument evaluates six domains: cognition, self, daily life and autonomy, social relationships, emotions, and physical problems. Items are rated on a 5-point scale, and responses are combined to generate a total score ranging from 0 to 100, with higher scores indicating better perceived quality of life after brain injury.

A validated questionnaire used to assess community integration following acquired brain injury. The instrument evaluates participation in three domains: home integration, social integration, and productive activities (e.g., work, education, or volunteering). Scores from individual items are summed to generate a total score, typically ranging from 0 to 29, with higher scores indicating greater independence and community participation.

Caregiver Burden Inventory (CBI): A validated self-report questionnaire used to assess the multidimensional burden experienced by caregivers. The instrument consists of 24 items grouped into five domains: time-dependence burden, developmental burden, physical burden, social burden, and emotional burden. Each item is rated on a 5-point scale (0-4), yielding a total score ranging from 0 to 96, with higher scores indicating greater caregiver burden. The CBI is widely used to evaluate the impact of caregiving responsibilities on caregivers' well-being and daily functioning.

Organized reporting of adverse events occurring during the study