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

N/ANot Yet RecruitingNCT07842328

University of British Columbia40 enrolled

Overview

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.

Study Type

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts