Paediatric school patients aged between 7 and 16 years with subacute or chronic spinal cord injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Participants will be randomly assigned to either the intervention group or the control group
using a simple randomisation technique. A computer-generated list of random numbers will
determine treatmen
Sponsors
Inrobics Social Robotics, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 7 and 16 years old 2. Clinically stable 3. Diagnosis of spinal cord injury below C6 in cases of AIS (ASIA Impairment Scale) severity A or B, or any level of incomplete spinal cord injury that allows reach with the upper limbs 4. Independent sitting (including technical aids such as belts, wedges, trunk supports, etc) 5. Parents, guardians or family members must have signed the corresponding informed consent form
Exclusion criteria
Exclusion criteria: 1. Unstable orthopaedic injuries such as unconsolidated fractures or unstable osteosynthesis systems in the upper limbs 2. Suffering from severe pain, joint stiffness and/or severe spasticity in the upper limbs 3. Severe bronchopneumopathy and/or heart disease requiring monitoring during exercise or a history of abnormal response to physical exertion prior to spinal cord injury 4. Severe visual impairments, cognitive impairment and/or incapacitating psychiatric illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 sys | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Spain
Contacts
Public ContactFuensanta García
Outcome results
None listed