临床试验雷达

Mean Improvement Index

The Mean Improvement Index is a metric that assesses the changes in WM span during training; and reflects near-transfer effect of WM Training on trained WM tasks. A Mean Improvement Index of ≥14 has been reported as an improvement cut-off value. The Mean Improvement Index is a built-in compliance/progress measure, calculated by subtracting the Start Index (results of day 2 and 3 of training) from the Max Index (results from the two best training days). Higher Improvement Index scores indicate greater compliance and progress with CWMT.

5 weeks

Executive functions

The cognitive battery will be performed using the Q-interactive digital platform and the TD Pilot (eye-tracking) as response modality. Four tests from the Wechsler Intelligence Scale for Children - 5th Edition (WISC-V) are used, including Matrix Reasoning (fluid intelligence and abstract problem-solving), Figure Weights (fluid reasoning and quantitative reasoning), Visual Puzzles (visual-spatial reasoning and mental flexibility), and Picture Span (visual working memory). These four tests yield raw scores based on the number of correct responses; these raw scores are then converted into standardized scaled scores (with a mean of 10 and a standard deviation of 3) using normative data for interpretation. The higher the score, the better the cognitive performance. WISC-V tests will be assessed at three time points during the study: (1) at baseline, (2)at post-intervention, (3) at 3-month follow-up.

through study completion, an average of 5 months

Language comprehension

The Computer-Based Instrument for Low Motor Language Testing (C-BiLLT) is used to assess language comprehension. C-BiLLT is specifically designed to assess language comprehension in non-verbal children with CP and complex communication needs, supporting the use of eye-tracking. The computer test consists of 86 items that are presented over two parts. Part I - measures a child's understanding of noun and verb phrases of animals, objects and people. Part II - the examiner presents 56 spoken sentences with increasing complexity of grammatical structures. For all items in this section, visual feedback regarding the selected response is shown to the child by a red square appearing around their chosen photograph. Scoring is based on the total number of correct responses, yielding a raw score that is subsequently converted into a standardized score using normative data.

through study completion, an average of 5 months

Heart Rate Variability (HRV) - time-domain

HRV will be collected using the Bittium Faros 360° Holter ECG device at 1000 Hz sampling rate, placed on a chest-strap during 5-min rest and during the performance of the neuropsychological assessments. HRV data will be first sequenced based on the start/end time of the neuropsychological task the investigators are interested in. The automatic threshold algorithm (Kubios HRV) will be applied to denoise the signal. Time-domain and frequency-domain parameters will be exported for statistical analysis using the Kubios Premium Software. Time-domain: The root mean square of successive differences (RMSSD) is measured in milliseconds (ms) and is calculated as the square root of the mean of the squared differences between adjacent normal-to-normal (NN) intervals. Although normative values vary by population, RMSSD typically ranges from around 20 to over 100 ms; with higher RMSSD indicating greater parasympathetic (vagal) activity, which is associated with better autonomic regulation.

through study completion, an average of 5 months

Heart Rate Variability (HRV) - frequency-domain

HRV will be collected using the Bittium Faros 360° Holter ECG device at 1000 Hz sampling rate, placed on a chest-strap during 5-min rest and during the performance of the neuropsychological assessments. HRV data will be first sequenced based on the start/end time of the neuropsychological task the investigators are interested in. The automatic threshold algorithm (Kubios HRV) will be applied to denoise the signal. Time-domain and frequency-domain parameters will be exported for statistical analysis using the Kubios Premium Software. Frequency-domain: The high-frequency (HF, frequency-domain) band is determined by performing spectral analysis to quantify the power within the 0.15-0.40 Hz range, reported in normalized units. A higher HF value generally indicates increased parasympathetic (vagal) activity, reflecting a healthier autonomic balance and better stress regulation.

through study completion, an average of 5 months

Heart Rate Variability (HRV) - stress index

The Kubios Premium Software automatically generates the Stress Index, SNS Index, and PNS Index based on the ECG signal. The Stress Index is a dimensionless measure reflecting overall autonomic stress levels, where higher values indicate greater stress.

through study completion, an average of 5 months

Heart Rate Variability (HRV) - SNS index

The SNS Index (Sympathetic Nervous System Index) is dimensionless and quantifies sympathetic activation-higher scores suggest increased sympathetic drive associated with stress responses. The higher the SNS index, the higher the stress response. SNS index does not have minimum and maximum values; it provides relative measures for comparing autonomic function across participants in different contexts (example, during rest and during performance)

through study completion, an average of 5 months

Heart Rate Variability (HRV) - PNS Index

The PNS Index (Parasympathetic Nervous System Index) is dimensionless, with higher values representing greater parasympathetic (vagal) activity and a more balanced autonomic state. The higher the PNS index, the better the autonomic response toward stressors. PNS index does not have minimum and maximum values; it provides relative measures for comparing autonomic function across participants in different contexts (example, during rest and during performance).

through study completion, an average of 5 months

Executive functions in home and school setting

To assess participants' executive functions behavior in a home and school setting, the investigators will use the Behaviour Rating Inventory of Executive Function - 2nd edition (BRIEF-2). The scale provides three composite indices: Behaviour Regulation Index, Emotion Regulation Index and Cognitive Regulation Index, and one unitary Global Executive Composite. BRIEF-2 will be filled in by parents and teachers. Each score is reported as a T-score, with a normative mean of 50 and a standard deviation of 10. Typically, the T-scores range from 40 to 80, where higher scores indicate greater executive function difficulties.

through study completion, an average of 5 months

Eye movements

Eye movement data will consist of different parameters of fixations and saccades, including duration, count, latency, velocity, amplitude and direction. Data will be collected using two screen-based eye-trackers, Tobii X3-120 and Tobii PC-Eye Mini, and analysed using the Tobii Pro Lab software. Participants will play six eye-tracking games from the EyeGaze Learning Curve software, which the investigators successfully used in their previous eye-tracking projects.

through study completion, an average of 5 months

Augmentative and Alternative Communication (AAC) competencies

The Augmentative and Alternative Communication Profile (AAC Profile) assesses the participant's competencies across four key domains: operational, linguistic, social, and strategic. Speech-language therapists complete the profile using a rating scale that assigns numerical scores-often referred to as profile points or scores-to each domain. These scores reflect the participant's current level of AAC proficiency, with higher scores indicating better performance. Each domain is evaluated separately, allowing the investigators and clinicians to pinpoint areas of strength and those requiring further intervention, while an aggregate score can provide an overall picture of AAC competence.

through study completion, an average of 5 months