Robotics- and AI-based hospital and home rehabilitation for children with spinal cord injury

Approved 24/09/2025, Ethics Committee for Clinical Research with Medicines at the Toledo University Hospital Complex (Av. del Río Guadiana, Toledo, 45007, Spain; +34 (0)925269200 extension: 48557; ceic-chto-secretario@sescam.jccm.es), ref: 2263

Assessments are conducted at four timepoints: T0 (baseline evaluation), T1 (post-clinical intervention), T2 (post-virtual intervention), and T3 (3-month follow-up)

Efficacy Measures:
1. PENN Spasm Frequency Scale: Assesses the frequency and severity of muscle spasms, providing a quantitative evaluation of spasticity (T0)
2. Electronic Spinal Cord Independence Measure (e-SCIM-III): Evaluates functional independence in patients with spinal cord injury (SCI) (T0, T1, T2, T3)

Emotional State:
1. Children’s Depression Inventory (CDI): Administered to participants under 16 years of age (T0, T1, T2, T3)
2. State-Trait Anxiety Inventory for Children (STAIC): Administered to participants aged 9–15 years (T0, T1, T2, T3)

Perceived Health and Mental Workload:
1. EQoL-5D-Y5L: Assesses perceived quality of life. (T0, T1, T2, T3)
2. Pain (VAS): Pain intensity is measured using the Visual Analogue Scale with emoticons suitable for children and adolescents (T0, T1, T2, T3)
3. NASA-TLX: Evaluates perceived mental workload and fatigue associated with the training tasks (T1, T2)

Cognitive Scales:
1. Digit Span (WISC-V subtest): Evaluates attention and working memory in participants under 16 years (T0, T1, T2, T3)
2. Face Perception Test: Assesses perceptual and attentional skills in participants under 16 years (T0, T1, T2, T3)
3. Executive Function Inventory (EFI): Completed by parents for children over 6 years to assess executive functioning in daily life (T0, T1, T2, T3)

Functional Scales:
1. Edinburgh Handedness Inventory: Determines hand dominance in participants over 3 years (T0)
2. Box and Block Test: Assesses gross manual dexterity in participants over 6 years (T0, T1, T2, T3)
3. Jebsen–Taylor Hand Function Test: Evaluates hand function and coordination in participants over 6 years (T0, T1, T2, T3)

Motor Assessment:
1. Upper Limb Kinematic Evaluation: Quantifies movement precision and quality during activities of daily living (ADLs) using the assistive social robotics system (see Annex 3) (T0, T2, T3)

Assessments are conducted at four timepoints: T0 (baseline evaluation), T1 (post-clinical intervention), T2 (post-virtual intervention), and T3 (3-month follow-up)

Usability Measures:
1. QUEST 2.0 (Quebec User Evaluation of Satisfaction with Assistive Technology): Assesses user satisfaction with the assistive device (T1, T2)
2. IPAQ Questionnaire: Measures time spent performing different physical activities in children and adolescents (T0, T1, T2, T3)
3. Hopkins Scale: Evaluates engagement in the training program for both adult and paediatric participants (T1, T2)

Device-Recorded Parameters:
1. All kinematic and physiological parameters are recorded using the Inrobics Rehab system and R software (version 4.3.1 for Ubuntu)
2. Range of Motion: Goniometric data capturing joint mobility (T1, T2)
3. Accuracy Rate: Quantifies successful task completion (T1, T2)
4. Trunk and Neck Deviation: Monitors postural deviations during training (T1, T2)
5. % Heart Rate Reserve (%HRR): Determines exercise intensity during sessions (T1, T2)
6. Motor Precision: Assesses the accuracy of reproduced target postures (T1, T2)
7. Reaction Time: Measures the latency between stimulus onset and movement initiation (T1, T2)
8. Engagement: Indicates the level of active participation throughout the task (T1, T2)
9. Performance by Activity Type: Evaluates execution across different motor games (e.g., dance, don’t stop, symbolic), combining metrics such as reaction time, memory rate, accuracy rate, learning rate, and execution speed (T1, T2)

User Satisfaction:
1. Self-Assessment Manikin (SAM): A pictorial, non-verbal scale assessing pleasure, arousal, and dominance associated with affective responses to stimuli (T1, T2)