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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Aged 19 years or older

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Humanoid Robot-Guided Active Play Intervention

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: NAO-Guided Active Play InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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
2

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
3

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
4

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.

Sponsors and contacts

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