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

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University of British Columbia

Status

Not yet enrolling

Conditions

Cerebral Palsy

Treatments

Behavioral: Humanoid Robot-Guided Active Play Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07842328
H26-01002

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

NAO-Guided Active Play Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Humanoid Robot-Guided Active Play Intervention

Trial contacts and locations

1

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Central trial contact

Julie Robillard, PhD; Jordan Stevenson, MSc

Data sourced from clinicaltrials.gov

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