Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy (REACT)

September 21, 2026 updated by: Julie Robillard, University of British Columbia

Robotic Engagement for Active Children's Therapy (REACT): NAO Cerebral Palsy Intervention

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julie Robillard, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Children & adolescents -

  • Aged 6-18 years with cerebral palsy
  • Gross Motor Function Classification System (GMFCS) Level I-IV
  • Sufficient receptive English language ability to follow simple verbal instructions from NAO and respond to interview questions, with or without caregiver or communication-aid support

Parent/caregiver -

  • Aged 19 years or older
  • Sufficient receptive English language ability to participate in interview and survey questions

Additional participation requirements -

  • Able to attend an in-person study visit at BC Children's Hospital
  • Enrollment is at the dyad level: each child/adolescent must participate with a parent/caregiver, and neither may participate independently

Exclusion Criteria:

  • GMFCS Level V
  • Uncontrolled seizure disorder or seizure within the previous 6 months
  • Severe visual or auditory impairment uncorrected by aids that would prevent interaction with NAO
  • Significant cognitive or communication impairment precluding assent and interview participation
  • Acute illness or cardiovascular condition contraindicating light-to-moderate physical activity

Additional consideration:

- Individuals will be encouraged not to participate if the child or caregiver reports a fear of robots

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NAO-Guided Active Play Intervention

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.

Other Names:
  • REACT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: From recruitment initiation through completion of enrollment, anticipated up to 15 months

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.
From recruitment initiation through completion of enrollment, anticipated up to 15 months
Consent Rate
Time Frame: From recruitment initiation through completion of enrollment, anticipated up to 15 months

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.
From recruitment initiation through completion of enrollment, anticipated up to 15 months
Session Completion Rate
Time Frame: At completion of the approximately 12-minute intervention during the single study visit

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.
At completion of the approximately 12-minute intervention during the single study visit
Intervention Fidelity
Time Frame: At completion of the approximately 12-minute intervention during the single study visit

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.
At completion of the approximately 12-minute intervention during the single study visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protocol Deviations
Time Frame: At completion of the approximately 90-minute study visit (Day 1), based on deviations recorded throughout the visit

Number and nature of protocol deviations occurring during study participation, recorded using the approved protocol deviation and adverse event log and summarized descriptively.
At completion of the approximately 90-minute study visit (Day 1), based on deviations recorded throughout the visit
Adverse Events
Time Frame: From enrollment through completion of the single study visit, approximately 90 minutes

Number and nature of adverse events occurring during study participation, recorded using the approved protocol deviation and adverse event log and summarized descriptively.
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
Time Frame: Immediately following the intervention during the single study visit

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.
Immediately following the intervention during the single study visit
REACT Caregiver Acceptability and Willingness Survey
Time Frame: Immediately following the intervention during the single study visit

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.
Immediately following the intervention during the single study visit
Participant-Reported Session Length and Sensor Comfort via REACT Facilitator Interview Guide
Time Frame: During the approximately 30-minute post-intervention interview conducted during the single study visit

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.
During the approximately 30-minute post-intervention interview conducted during the single study visit
Participant and Caregiver Qualitative Experience
Time Frame: Immediately following the intervention; approximately 30-minute interview during the single study visit

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.
Immediately following the intervention; approximately 30-minute interview during the single study visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
OMNI Rating of Perceived Exertion Scale: Perceived Exertion
Time Frame: Immediately following the approximately 12-minute intervention

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.
Immediately following the approximately 12-minute intervention
Heart Rate Response
Time Frame: During a 2-minute resting baseline and the approximately 12-minute intervention

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.
During a 2-minute resting baseline and the approximately 12-minute intervention
Accelerometer-Derived Movement Output
Time Frame: During the 2-minute seated resting baseline and the approximately 12-minute NAO-guided intervention during the single study visit

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.
During the 2-minute seated resting baseline and the approximately 12-minute NAO-guided intervention during the single study visit
Sensor Wear Time
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.

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.
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
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

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.
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
Time Frame: From the 2-minute resting baseline through completion of the approximately 12-minute NAO-guided intervention during the single study visit

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.
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
Time Frame: During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)

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.
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
Time Frame: During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)

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.
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
Time Frame: During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)

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.
During the approximately 12-minute NAO-guided intervention during the single study visit (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Julie Robillard, PhD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 21, 2026

First Posted (Actual)

September 25, 2026

Study Record Updates

Last Update Posted (Actual)

September 25, 2026

Last Update Submitted That Met QC Criteria

September 21, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H26-01002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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