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Cerebral PalsyREACTNCT07842328

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

A study testing Humanoid Robot-Guided Active Play Intervention in people with Cerebral Palsy, run by University of British Columbia at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Cerebral Palsy
What is being tested?
Humanoid Robot-Guided Active Play Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
15 Nov 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jordan Stevenson, MSc contact

604-875-3923

jordan.stevenson@ubc.ca

Julie Robillard, PhD contact

604-875-3923

julie.robillard@ubc.ca

Canada1 site
  • BC Children's Hospital

    Vancouver, British Columbia, V6H 3N1

    Jordan Stevenson, MSc, 604-875-3923, jordan.stevenson@ubc.ca

    Julie Robillard, PhD, 604-875-3923, julie.robillard@ubc.ca

Other trials in Canada

About this study

Official title: Robotic Engagement for Active Children's Therapy (REACT): NAO Cerebral Palsy Intervention

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.

Read the detailed 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.

Conditions
Cerebral Palsy
Being tested
Humanoid Robot-Guided Active Play Intervention
Keywords
Socially Assistive Robot, Humanoid Robot, NAO Robot, Active Play, Pediatric Rehabilitation, Physical Activity, Feasibility, Acceptability, Human-Robot Interaction, Pediatrics
Medical subject headings
Cerebral Palsy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Humanoid Robot-Guided Active Play InterventionBehavioural

    Also called REACT

    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.

Study groups in NCT07842328
Study groupRoleWhat they receive
NAO-Guided Active Play InterventionExperimentalParticipants 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.
Receives: Behavioral: Humanoid Robot-Guided Active Play Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Secondary outcomes (6)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Immediately following the intervention during the single study visit

  5. 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.

    Measured: During the approximately 30-minute post-intervention interview conducted during the single study visit

  6. 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.

    Measured: Immediately following the intervention; approximately 30-minute interview during the single study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07842328
Sponsor's protocol ID
H26-01002
Acronym
REACT
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be made available to external researchers. Study data will be de-identified and stored securely on UBC OneDrive, with access limited to the research team, and retained for five years after publication in accordance with the approved ethics protocol.

Publications

  • 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.

    PubMed 34785096
  • 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.

    PubMed 32206590
  • 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.

    PubMed 37788925
  • 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.

    PubMed 28213598
  • 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.

    PubMed 26853808
  • 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.

    PubMed 25627218
  • 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.

    PubMed 30806105
  • 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.

    PubMed 31608150
  • 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.

    PubMed 19362699

Questions about this trial

What is this clinical trial studying?

A study testing Humanoid Robot-Guided Active Play Intervention in people with Cerebral Palsy, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jordan Stevenson, MSc (604-875-3923, jordan.stevenson@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: From recruitment initiation through completion of enrollment, anticipated up to 15 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07842328, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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