Skip to main content
OpenTrials
Completed

NCT Number: NCT06993389

AI-based Model for Rehabilitation Engagement and Motor Performance Evaluation in Pediatric Patients

What is the purpose of this study? This study wants to learn how the physiological signals and movement data can help researchers understand and predict how children with neuromotor impairments engage with rehabilitation.

Who can take part? 40 participants between 5 and 17 years old will take part. Half of them will be children with neurotypical development (control). The other half will be children with neuromotor impairments.

What will happen in the study? Children within the control group will take part in 1 rehabilitation session, while those with neuromotor impairments will take part in 2 to 3 rehabilitation sessions as part of the treatment plan already provided by their referring physicians.

During each session, researchers will collect: (i) physiological signals like heart activity (ECG), heart rate variability (HRV), and electrodermal activity (EDA); (ii) movement data; (iii) exergames scores and motor performance data; (iv) questionnaires filled out by therapists to understand how engaged the participant is.

Children will use one of two technology-assisted rehabilitation systems during their sessions: either the Lokomat (robotic exoskeleton that supports children with impairments in walking) or the GRAIL system (a treadmill system with motion tracking and extended reality).

Why is this study important? Researchers will use the data to understand and predict how each child responds to therapy and engage with it. These analyses will help therapists adjust rehabilitation settings in real-time, offering more personalized and effective care for children with neuromotor impairments.

Completed

Looking for future studies?

Notify Me

Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Scientific Institute IRCCS E.Medea

Bosisio Parini, LC, 23842, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged between 5 and 17 with typical development.
  • Subjects aged between 5 and 17 years with neuromotor impairments who are undergoing rehabilitation therapy using the Lokomat and GRAIL devices, according to the existing clinical plan.

Exclusion criteria

  • Uncooperative subjects.

Treatment and study plan

inapplicable

Other

Inapplicable

Primary outcomes

  1. Pediatric Rehabilitation Intervention Measure of Engagement - Observation (PRIME-O)

    Time frame: Baseline

    This validated self-reported questionnaire is intended to capture observable indicators of patient and therapist engagement in therapy sessions. It is composed of 10 items, divided into 3 sections. Section A (4 items) groups items exclusively related to the patient engagement evaluation, Section B (4 items) lists items exclusively devoted to therapists, Section C (2 items) contains items that evaluate the interaction between patient and therapist. Each item is proposed on a 5-points Likert scale, with minimum value 0 and maximum value 4. Higher values stand for higher engagement levels.

Secondary outcomes

  1. Service Provider-Rated Measure of Client Engagement (PRIME-SP)

    Time frame: Baseline

    This measure is intended to capture the therapist's observation of patient engagement. PRIME-SP is a validated self-reported questionnaire that is composed of three main parts: Part A, where the therapist can perform an overall evaluation of patient engagement according to a 5-point Likert scale (from 0 to 4, with higher values corresponding to positive engagement); Part B, where the therapist can perform a domain-dependent (affective, cognitive, behavioral domains) evaluation of patient engagement according to a 5-point Likert scale (from 0 to 4, with higher values corresponding to positive engagement); Part C, where the therapist can take free notes about factors and circumstances that he/she believes may have affected patient engagement in the session.

  2. Self-Assessment Manikin (SAM)

    Time frame: Baseline

    The Self-Assessment Manikin is a self-reported questionnaire that evaluates the emotional valence, arousal, and dominance of the subject in relation to a specific context. It is composed of 3 items, namely valence, arousal, and dominance, to which the therapist has to answer according to its feelings regarding the participant's emotional state. Each item is measured through a 9-point Likert scale, from 1 to 9, where:

    • valence: lower values stand for greater unpleasantness; higher values for higher pleasantness.
    • arousal: lower values stand for lower affective activation; higher values for higher affective activation.
    • dominance: lower values stand for lower control over the felt emotion; higher values for control over the felt emotion.
  3. Positive Affect and Negative Affect Scale (PANAS)

    Time frame: Baseline

    PANAS is a self-reported questionnaire that is used to assess the positive and negative affective states. It is composed of two distinct scales: Positive Affect (PA) and Negative Affect (NA), with 20 items in total. Each item is structured with a 5-point Likert scale, from 1 to 5. The items are the following: interested, distressed, excited, upset, strong, guilty, scared, hostile, enthusiastic, proud, irritable, alert, ashamed, inspired, nervous, determined, attentive, jittery, active, and afraid. For each item, higher values on the Likert scale represent higher agreement with that specific word describing different feelings and emotions. Higer values for the items interested, excited, strong, enthusiastic, proud, alert, inspired, determined, attentive, active represent higher levels of affective engagement; conversely, higher values for the items distressed, upset, guilty, scared, hostile, irritable, ashamed, nervous, jittery, afraid represent lower levels of affective engagement.

  4. Heart Rate (HR)

    Time frame: Baseline

    It measures the number of heartbeats per minute. It is computed as the average number of R-peaks that occur within a minute. A moderately elevated HR may indicate physical or emotional engagement. Extremely high or low values might reflect discomfort or disengagement. A slightly increased HR, compared to rest condition, is generally interpreted as a positive sign of engagement during active tasks.

  5. Root Mean Square of Successive Differences (RMSSD)

    Time frame: Baseline

    RMSSD is a measure of heart rate variability (HRV) that reflects short-term variations in the time between heartbeats. It is calculated as the square root of the mean squared differences between successive RR intervals (e.g., intervals between successive R-peaks). RMSSD is commonly associated with parasympathetic (rest-and-digest) activity. Higher RMSSD values are typically interpreted as positive, as they indicate a more regulated autonomic state and lower distress, potentially supporting better engagement.

  6. Low Frequency power of Heart Rate Variability (HRV LF)

    Time frame: Baseline

    HRV LF refers to the power of HRV in the low frequency range (typically 0.04-0.15 Hz). It is calculated using spectral analysis of RR intervals. Moderate LF values with respect to rest condition may suggest adaptive physiological arousal, but excessively high LF can reflect distress or discomfort.

  7. High Frequency power of Heart Rate Variability (HRV HF)

    Time frame: Baseline

    HRV HF is the high-frequency component of HRV (0.15-0.4 Hz), associated with parasympathetic nervous system activity and respiratory influences. It is calculated using spectral analysis of RR intervals. In the context of rehabilitation, higher HF values typically indicate calm, focused engagement and are thus seen as positive when participants are actively involved without distress.

  8. Average Skin Conductance Level (AvSCL)

    Time frame: Baseline

    AvSCL is the average level of the tonic (slow-changing) component of skin conductance over time. It reflects general autonomic arousal. It is calculated from electrodermal activity (EDA) after separating the tonic and phasic components as the mean value over time of the tonic component. Moderately higher AvSCL values suggest increased physiological arousal, which is typically positive if not excessive, as it indicates increased engagement into therapy.

  9. Non-Specific Skin Conductance Responses (NSSCR)

    Time frame: Baseline

    NSSCR represents the frequency of phasic skin conductance responses (rapid changes of skin conductance level, SCR) per minute. It is calculated by counting the number of over-threshold SCR peaks. A higher NSSCR generally indicates greater arousal and cognitive engagement and is considered a positive marker when aligned with task demands.

  10. Low Frequency power of Skin Conductance Response (SCR LF)

    Time frame: Baseline

    SCR LF measures the power of the skin conductance phasic signal in the low frequency band (0.045-0.15 Hz), focusing on slow oscillations in the phasic component. It is obtained using spectral analysis after SCR decomposition. An increased SCR LF may indicate sustained physiological activation and is generally interpreted as a positive indicator of cognitive and emotional engagement.

  11. Walk Cadence

    Time frame: Baseline

    Walk Cadence is the number of steps a person takes per minute. It is calculated using inertial sensors placed on L5. Higher cadence typically reflects greater motor activation and is considered a positive outcome, especially when aligned with therapeutic goals.

  12. Step Time

    Time frame: Baseline

    Step time is the average time taken to complete one step. It is calculated as the time between heel strikes of alternating feet. Lower step times (faster stepping) can reflect better motor coordination and task engagement. A decrease in step time, if associated with smooth and safe gait, is considered a positive sign of engagement and motor activation.

  13. Exergame score

    Time frame: Baseline

    The exergame score represents the participant's performance level in gamified motor rehabilitation exercises. It is calculated from metrics such as task accuracy, reaction time, and completion rate, depending on the game design. Higher scores generally indicate better motor performance and sustained attention and are also interpreted as a positive measure of both physical and cognitive engagement during the session. A unique normalized scale across different exergames is not available.

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Collaborators

  • Politecnico di Milano

Registry information

Acronym: AI-REMAP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.