An interventional study of Humanoid Robot-Guided Active Play Intervention in Cerebral Palsy, sponsored by University of British Columbia. Not yet recruiting at 1 site in Canada. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of British Columbia · Not applicable, Interventional, and Other
Cerebral palsy can make it difficult for children and adolescents to participate consistently in enjoyable physical activity. This study will examine whether a small humanoid robot called NAO can deliver a short, story-based active-play session that encourages movement and participation. Children and adolescents with cerebral palsy will complete one session at BC Children's Hospital. The study will assess whether the intervention is practical to deliver, acceptable to children and caregivers, and safe to use. Participants and caregivers will also provide feedback about their experience. The findings will be used to refine the intervention and plan a future larger trial.
This is a single-session, single-arm, mixed-methods feasibility and acceptability study of a humanoid social robot-delivered, movement-based narrative active-play intervention for children and adolescents with cerebral palsy. The intervention is delivered by the NAO humanoid robot and is structured as a guided story in which the participant and robot move together through a sequence of physical actions. The intervention is designed around engagement and active participation rather than conventional prescriptive exercise delivery.
Participants across Gross Motor Function Classification System (GMFCS) Levels I-IV will complete an in-person session at BC Children's Hospital. The protocol includes parallel ambulatory and non-ambulatory versions that share a common narrative structure and movement library. During the session, behavioural, physiological, and movement-related information will be collected to characterize participant engagement and physical activity. Following the intervention, children or adolescents and their caregivers will complete measures related to engagement, exertion, comfort, acceptability, willingness to participate in the future, and their experience of the intervention. Semi-structured exit interviews will also be conducted.
The primary purpose of the study is to determine the feasibility and acceptability of delivering the intervention. Feasibility will be characterized using indicators including recruitment and consent, session completion, intervention fidelity, protocol deviations, adverse events, and measurement-protocol completeness. Qualitative feedback will be used to identify barriers, facilitators, and potential modifications to the intervention and study procedures.
The study is not designed or powered to evaluate intervention efficacy. Findings will instead be used to refine the intervention, study procedures, and outcome measures and to inform the design of a future definitive randomized controlled trial.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 40 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Children \& adolescents -
Parent/caregiver -
Additional participation requirements -
Exclusion Criteria:
Additional consideration:
- Individuals will be encouraged not to participate if the child or caregiver reports a fear of robots
Participants will complete one in-person, NAO-delivered, movement-based narrative active-play session. The intervention includes parallel ambulatory (GMFCS I-III) and non-ambulatory (GMFCS IV) versions, with both versions sharing a common narrative structure and movement library.
Behavioral: Humanoid Robot-Guided Active Play Intervention
A humanoid social robot (NAO, SoftBank Robotics) guides the participant through a single, story-based active-play session in which physical movements are embedded within a narrative. The intervention is designed to promote engagement and active participation rather than conventional prescriptive exercise delivery. Parallel ambulatory (GMFCS I-III) and non-ambulatory (GMFCS IV) versions are used, with both sharing a common narrative structure and movement library.
Also known as: REACT
Recruitment Rate
Number of child/adolescent participants enrolled relative to the prespecified recruitment target. Recruitment will be summarized descriptively. Progression will be interpreted as: target achieved = proceed; below target but recruitment achievable with an adjusted strategy or timeline = proceed with modification; below target with no feasible recruitment pathway = reconsider.
Time frame: From recruitment initiation through completion of enrollment, anticipated up to 15 months
Consent Rate
Percentage of eligible child-caregiver dyads invited to participate who provide caregiver consent and child/adolescent assent and enroll in the study. Prespecified progression thresholds are ≥80% = proceed; 60-79% = proceed with modification; \<60% = reconsider.
Time frame: From recruitment initiation through completion of enrollment, anticipated up to 15 months
Session Completion Rate
Percentage of enrolled child/adolescent participants who complete the planned NAO-guided active-play intervention session. Prespecified progression thresholds are ≥80% = proceed; 60-79% = proceed with modification; \<60% = reconsider.
Time frame: At completion of the approximately 12-minute intervention during the single study visit
Intervention Fidelity
Fidelity to the prespecified NAO-guided intervention protocol will be assessed using the approved intervention fidelity checklist and summarized as a percentage. Prespecified progression thresholds are ≥80% = proceed; 60-79% = proceed with modification; \<60% = reconsider.
Time frame: At completion of the approximately 12-minute intervention during the single study visit
Protocol Deviations
Number and nature of protocol deviations occurring during study participation, recorded using the approved protocol deviation and adverse event log and summarized descriptively.
Time frame: At completion of the approximately 90-minute study visit (Day 1), based on deviations recorded throughout the visit
Adverse Events
Number and nature of adverse events occurring during study participation, recorded using the approved protocol deviation and adverse event log and summarized descriptively.
Time frame: From enrollment through completion of the single study visit, approximately 90 minutes
REACT Post-Narrative Intervention Likert Scale: Child/Adolescent Engagement and Intention to Repeat
Child/adolescent engagement and intention to repeat the activity will be assessed using the age-appropriate REACT Post-Narrative Intervention Likert Scale (child version, ages 6-13; adolescent version, ages 14-18). Each version contains five items assessing enjoyment, desire to continue the activity, ease of performing the movements, experience interacting with NAO, and willingness to participate in a similar session again. Each item is rated from 1 to 5, with higher scores indicating a more positive response on that item. Responses will be summarized descriptively at the item level; no composite or total score will be calculated.
Time frame: Immediately following the intervention during the single study visit
REACT Caregiver Acceptability and Willingness Survey
Caregiver acceptability and willingness will be assessed using the purpose-built REACT Caregiver Acceptability and Willingness Survey. The survey contains 10 Likert items assessing perceived child enjoyment, engagement, comfort and safety, overall experience, willingness to participate again, willingness to participate in a longer program, comfort with use in therapy or at home, and willingness to recommend the session to other families. Each item is rated from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater agreement and a more positive response on that item. Responses will be summarized descriptively at the item level; no composite or total score will be calculated.
Time frame: Immediately following the intervention during the single study visit
Participant-Reported Session Length and Sensor Comfort via REACT Facilitator Interview Guide
Child/adolescent perceptions of intervention length and comfort while wearing the arm-strap heart-rate monitor and wrist-worn accelerometer will be assessed using purpose-built questions and prompts in the REACT Facilitator Interview Guide. Participants will be asked whether the activity felt too long, too short, or appropriate in length and whether the study sensors caused discomfort or were noticeable during participation. Responses will be analyzed qualitatively; no numerical scale or composite score will be calculated.
Time frame: During the approximately 30-minute post-intervention interview conducted during the single study visit
Participant and Caregiver Qualitative Experience
A semi-structured dyadic interview with the child/adolescent and caregiver will explore their experience of the NAO-guided active-play intervention, including perceived acceptability, what worked or did not work, barriers and facilitators to participation, and recommended refinements to the intervention and study procedures.
Time frame: Immediately following the intervention; approximately 30-minute interview during the single study visit
OMNI Rating of Perceived Exertion Scale: Perceived Exertion
Child/adolescent perceived exertion will be assessed using the cerebral palsy-specific OMNI Rating of Perceived Exertion scale, with ambulatory and non-ambulatory pictorial versions used as appropriate. The scale ranges from 0 ("not tired at all") to 10 ("very, very tired"), with higher scores indicating greater perceived exertion. Higher scores do not inherently represent a better or worse outcome.
Time frame: Immediately following the approximately 12-minute intervention
Heart Rate Response
Heart rate will be recorded using an arm-strap heart rate monitor during a seated resting baseline and the NAO-guided active-play intervention. Heart rate data will be summarized descriptively to characterize physiological response during participation.
Time frame: During a 2-minute resting baseline and the approximately 12-minute intervention
Accelerometer-Derived Movement Output
Movement data will be collected using a wrist-worn accelerometer and summarized descriptively to characterize movement and physical activity during the NAO-guided active-play intervention.
Time frame: During the 2-minute seated resting baseline and the approximately 12-minute NAO-guided intervention during the single study visit
Sensor Wear Time
Wear time for the arm-strap heart-rate monitor and wrist-worn accelerometer will be recorded in minutes from initial sensor placement to removal. Wear time will be summarized descriptively for each sensor separately; no combined wear-time score will be calculated.
Time frame: From sensor placement before the 2-minute resting baseline through sensor removal immediately following the approximately 12-minute NAO-guided intervention during the single study visit.
Sensor Device-Removal Events
The number of heart-rate monitor and accelerometer removal events occurring during the planned sensor-wear period will be recorded and summarized descriptively as counts. Events will be reported by sensor type.
Time frame: From sensor placement before the 2-minute resting baseline through completion of the approximately 12-minute NAO-guided intervention during the single study visit
Per-Instrument Sensor Data Completeness
Data completeness will be assessed separately for the arm-strap heart-rate monitor and wrist-worn accelerometer as the percentage of the planned recording period for which sensor data are available. Higher percentages indicate greater data completeness. Heart-rate and accelerometer completeness will be reported separately; no combined score will be calculated.
Time frame: From the 2-minute resting baseline through completion of the approximately 12-minute NAO-guided intervention during the single study visit
Behavioural Engagement Assessed Using a Study-Specific Structured Video Coding Protocol
Behavioural engagement during the NAO-guided intervention will be assessed from video recordings using a study-specific structured coding protocol developed and piloted by two independent coders. Behavioural engagement codes will be summarized descriptively; no standardized scale or composite score will be calculated. Inter-rater reliability will be established on a minimum of 20% of recordings, with a target Cohen's κ ≥0.70 before full coding.
Time frame: During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)
Movement Quality Assessed Using a Study-Specific Structured Video Coding Protocol
Movement quality during the NAO-guided intervention will be assessed from video recordings using a study-specific structured coding protocol developed and piloted by two independent coders. Movement-quality codes will be summarized descriptively; no standardized scale or composite score will be calculated. Inter-rater reliability will be established on a minimum of 20% of recordings, with a target Cohen's κ ≥0.70 before full coding.
Time frame: During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)
Critical Incidents Assessed Using a Study-Specific Structured Video Coding Protocol
Critical incidents occurring during the NAO-guided intervention will be identified from video recordings using a study-specific structured coding protocol developed and piloted by two independent coders. Critical-incident codes will be summarized descriptively; no standardized scale or composite score will be calculated. Inter-rater reliability will be established on a minimum of 20% of recordings, with a target Cohen's κ ≥0.70 before full coding.
Time frame: During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)
Plan to share: No — Individual participant data will not be made available to external researchers. Study data will be de-identified and stored securely on UBC OneDrive, with access limited to the research team, and retained for five years after publication in accordance with the approved ethics protocol.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 13 months is close to that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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