Robotic Engagement for Active Children's Therapy (REACT): NAO Cerebral Palsy Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Humanoid Robot-Guided Active Play Intervention (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: 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.
Consent Rate
时间窗: 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.
Session Completion Rate
时间窗: 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.
Intervention Fidelity
时间窗: 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.
次要结局
- Protocol Deviations(At completion of the approximately 90-minute study visit (Day 1), based on deviations recorded throughout the visit)
- Adverse Events(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(Immediately following the intervention during the single study visit)
- REACT Caregiver Acceptability and Willingness Survey(Immediately following the intervention during the single study visit)
- Participant-Reported Session Length and Sensor Comfort via REACT Facilitator Interview Guide(During the approximately 30-minute post-intervention interview conducted during the single study visit)
- Participant and Caregiver Qualitative Experience(Immediately following the intervention; approximately 30-minute interview during the single study visit)
研究者
Julie Robillard
Associate Professor of Neurology
University of British Columbia