ROBO-PAWS: Robot-Dog-Assisted Walking

Sponsor
Koç University
Study ID
NCT07603180
Status
Not Yet Recruiting

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Conditions

  • Fatigue
  • Quality of Life
  • Sleep Quality

Eligibility Criteria

Sex
ALL
Age
2 Years - 7 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
May 22, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: ROBO-PAWS Group
    Children in the intervention group will receive standard care in addition to participating in robot-dog-assisted walking sessions twice daily (morning and evening) for one month. Each walking session will last 15 minutes and will be conducted within the clinical setting under the supervision of a nurse/researcher to ensure participant safety. The total daily walking duration will be 30 minutes. Before the intervention and after completion of the intervention period, parents will complete questionnaires assessing sleep quality, quality of life, and fatigue. If the child experiences fatigue, dizziness, discomfort, or any other adverse symptoms during the walking sessions, the intervention will be immediately discontinued. The robotic dog will be disinfected before each use to maintain hygiene and infection control standards.
  • No Intervention: Control Group
    Children in the control group will receive standard medical treatment and routine nursing care only. Within routine clinical practice, children are allowed to leave their rooms and walk freely when they wish, although they are generally on bed rest for most of the day. They may also participate in unstructured playroom activities such as reading books, drawing, or playing games. However, no structured or supervised physical activity program aimed at increasing physical activity levels is routinely provided. Therefore, children in the control group will continue their usual daily activities within the standard clinical care environment.

Primary Outcome Measure

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). ]

Central Contacts

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