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NCT Number: NCT07603180

ROBO-PAWS: Robot-Dog-Assisted Walking

Childhood cancers affect approximately 400,000 children and adolescents worldwide each year. Although advances in treatment have significantly improved survival rates, children undergoing cancer treatment continue to experience a wide range of treatment-related symptoms and complications. Among these, fatigue and sleep disturbances are particularly common and may persist throughout treatment and survivorship, negatively affecting psychological well-being, cognitive functioning, and overall quality of life. Reduced physical activity during treatment is strongly associated with worsening fatigue, impaired sleep, and decreased quality of life in pediatric oncology patients. However, treatment side effects, prolonged hospitalization, infection risk, and lack of motivating play-based activities often limit children's participation in physical activity during treatment. Recent evidence suggests that physical activity interventions may help reduce fatigue and improve well-being in children with cancer, yet engaging and age-appropriate non-pharmacological interventions remain limited, especially for younger children.

This pilot randomized controlled trial aims to evaluate the feasibility and potential effects of a robot-dog-assisted walking intervention on sleep quality, fatigue, and quality of life among children aged 2-7 years undergoing cancer treatment.

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Key information

Conditions

Sleep Quality Dyssomnias Fatigue Mental Disorders Neoplasms Nervous System Diseases Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a robot-dog-assisted walking intervention for children aged 2-7 years receiving active cancer treatment. The intervention is designed to promote physical activity through interactive and play-based walking sessions supported by a robotic dog companion.

Children undergoing cancer treatment frequently experience fatigue, sleep disturbances, reduced physical activity, and decreased quality of life during treatment. Hospitalization, treatment-related side effects, infection precautions, and limited access to motivating activities may contribute to sedentary behaviors in this population. Previous studies have suggested that physical activity interventions may improve symptom management and well-being in pediatric oncology patients; however, engaging and developmentally appropriate interventions for young children remain limited.

Participants will be randomly assigned to either the robot-dog-assisted walking intervention group or the control group receiving standard care. The intervention will consist of structured walking activities integrated into the child's routine during hospitalization or outpatient treatment visits. Feasibility outcomes will include recruitment, retention, adherence, acceptability, and safety of the intervention. Preliminary clinical outcomes will include sleep quality, fatigue, and quality of life.

The findings of this study will provide preliminary evidence regarding the feasibility and potential benefits of integrating robot-assisted play and movement interventions into supportive pediatric oncology care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 2 and 7 years,
  • Diagnosed with cancer and currently receiving active treatment,
  • Pain level not severe enough to interfere with mobilization (FLACC or Wong-Baker FACES score ≤ 4),
  • Diagnosed within the previous 1 month,
  • Medically stable and approved by the physician to participate in light-intensity walking activities,
  • Expected to remain hospitalized for at least 1 month to allow completion of the study protocol,
  • Not scheduled for hematopoietic stem cell transplantation (HSCT) and not currently undergoing HSCT,
  • Hemoglobin level adequate for participation in walking activities (>10 g/dL),
  • No significant impairment in consciousness, balance, or motor functions due to heavy analgesic or sedative medication use.

Exclusion criteria

  • Resting SpO₂ <94%, requirement for ≥2 L/min oxygen support, or recurrent desaturation episodes within the last 24 hours,
  • Heart rate or respiratory rate significantly elevated or irregular for age,
  • Hemodynamic instability,
  • Visual, hearing, or severe cognitive impairment that would prevent interaction with the robotic dog,
  • Increased mobilization risk due to high-dose corticosteroid treatment or medications associated with neurotoxicity,
  • Motor function limitations that would interfere with safe walking,
  • Concurrent severe infection or serious treatment-related complications (e.g., grade 3-4 mucositis or severe neutropenia requiring isolation),
  • Children receiving end-of-life care.

Treatment and study plan

Robot-Dog-Assisted Walking

Device

The intervention will use AIBO (Sony Interactive Entertainment, ERS-1000), an artificial intelligence-based robotic dog designed to support social interaction and engagement with children. AIBO is equipped with advanced sensors, interactive movement capabilities, microphones, speakers, and touch-responsive features that allow it to respond to voice commands, physical contact, and environmental stimuli. Its natural dog-like movements, facial expressions displayed through OLED eyes, and playful behaviors are intended to attract children's attention and encourage participation in walking activities. In addition, the device includes motion and distance sensors that enable safe navigation within the clinical environment.

Participants in the intervention group will receive standard medical and nursing care in addition to a robot-dog-assisted walking intervention using AIBO (Sony Interactive Entertainment, ERS-1000). Children will participate in supervised walking sessions twice daily (mornin

Primary outcomes

  1. Sleep quality

    Time frame: Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).

    Sleep quality will be assessed using the Visual Sleep Scale (VSS), a child-friendly visual instrument developed for pediatric populations. The scale is rated from 1 ("Very Poor") to 10 ("Very Good") and includes visual cues such as sad, neutral, and smil

  2. Health-related quality of life

    Time frame: Baseline (Day 1, before intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).

    Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL), a validated 23-item instrument designed for children and adolescents aged 2-18 years. The scale evaluates physical, emotional, social, and school functioning. Items are scored on a 0-100 scale, with higher scores indicating better perceived quality of life. Total Scale Score, Physical Health Summary Score, and Psychosocial Health Summary Score will be calculated. Parent proxy-reports will be used in this study.

Secondary outcomes

  1. Fatigue

    Time frame: Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).

    Fatigue will be assessed using the Visual Fatigue Scale, a single-item self-report measure developed to evaluate fatigue severity. The scale ranges from 0 ("No fatigue") to 10 ("Severe and overwhelming fatigue"). Higher scores indicate greater fatigue severity. The instrument has demonstrated acceptable validity and reliability in clinical populations and will be used to monitor changes in fatigue levels throughout the intervention period.

Study contacts

Contact information is provided by the study sponsor or research team.

Remziye Semerci Şahin, PhD

CONTACT

[email protected]

+90 535 011 2821

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

ROBO-PAWS: A Pilot Randomized Controlled Trial of Robot-Dog-Assisted Walking to Improve Sleep Quality, Fatigue, and Quality of Life in Pediatric Oncology Patients

Acronym: ROBO-PAWS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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