ROBO-PAWS: Robot-Dog-Assisted Walking
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-7
SponsorKoç University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Robot-Dog-Assisted Walking
DeviceThe 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ROBO-PAWS GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Sleep quality
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
Time frame
Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).2
Health-related quality of life
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.
Time frame
Baseline (Day 1, before intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).Secondary outcomes
1
Fatigue
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.
Time frame
Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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