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

NCT07842328 | Not Yet Recruiting

• 1 other identifier: H26-01002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

Socially Assistive Robot; Humanoid Robot; NAO Robot; Active Play; Pediatric Rehabilitation; Physical Activity; Feasibility; Acceptability; Human-Robot Interaction; Pediatrics

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Secondary Outcomes (6)

• 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

Other Outcomes (9)

• OMNI Rating of Perceived Exertion Scale: Perceived Exertion

  Immediately following the approximately 12-minute intervention

• Heart Rate Response

  During a 2-minute resting baseline and the approximately 12-minute intervention

• Accelerometer-Derived Movement Output

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

Study Arms (1)

NAO-Guided Active Play Intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: REACT

NAO-Guided Active Play Intervention

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (9)

• Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.

  PMID: 34785096 BACKGROUND

• Patel DR, Neelakantan M, Pandher K, Merrick J. Cerebral palsy in children: a clinical overview. Transl Pediatr. 2020 Feb;9(Suppl 1):S125-S135. doi: 10.21037/tp.2020.01.01.

  PMID: 32206590 BACKGROUND

• Sakzewski L, Reedman SE, Elliott C, Ziviani J, Novak I, Trost S, Majnemer A, Comans T, Shikako K, Ware RS, McNamara L, Williams S, Keramat SA, Brookes D, Boyd RN. Participate CP 2: optimising participation in physically active leisure for children with cerebral palsy - protocol for a phase III randomised controlled trial. BMJ Open. 2023 Oct 3;13(10):e075570. doi: 10.1136/bmjopen-2023-075570.

  PMID: 37788925 BACKGROUND

• Avery KN, Williamson PR, Gamble C, O'Connell Francischetto E, Metcalfe C, Davidson P, Williams H, Blazeby JM; members of the Internal Pilot Trials Workshop supported by the Hubs for Trials Methodology Research. Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open. 2017 Feb 17;7(2):e013537. doi: 10.1136/bmjopen-2016-013537.

  PMID: 28213598 BACKGROUND

• Verschuren O, Peterson MD, Balemans AC, Hurvitz EA. Exercise and physical activity recommendations for people with cerebral palsy. Dev Med Child Neurol. 2016 Aug;58(8):798-808. doi: 10.1111/dmcn.13053. Epub 2016 Feb 7.

  PMID: 26853808 BACKGROUND

• Fragala-Pinkham M, O'Neil ME, Lennon N, Forman JL, Trost SG. Validity of the OMNI rating of perceived exertion scale for children and adolescents with cerebral palsy. Dev Med Child Neurol. 2015 Aug;57(8):748-53. doi: 10.1111/dmcn.12703. Epub 2015 Jan 27.

  PMID: 25627218 BACKGROUND

• Buitrago JA, Bolanos AM, Caicedo Bravo E. A motor learning therapeutic intervention for a child with cerebral palsy through a social assistive robot. Disabil Rehabil Assist Technol. 2020 Apr;15(3):357-362. doi: 10.1080/17483107.2019.1578999. Epub 2019 Feb 26.

  PMID: 30806105 BACKGROUND

• Lancaster GA, Thabane L. Guidelines for reporting non-randomised pilot and feasibility studies. Pilot Feasibility Stud. 2019 Oct 6;5:114. doi: 10.1186/s40814-019-0499-1. eCollection 2019.

  PMID: 31608150 BACKGROUND

• Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.

  PMID: 19362699 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Julie Robillard, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Stevenson, MSc

CONTACT

604-875-3923; jordan.stevenson@ubc.ca

Julie Robillard, PhD

CONTACT

604-875-3923; julie.robillard@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)