Clinical trial · Interventional
ROBO-PAWS: Robot-Dog-Assisted Walking
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Sleep Quality | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robot-Dog-Assisted Walking | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ROBO-PAWS Group
- description
- 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.
- interventionNames
- Device: Robot-Dog-Assisted Walking
- type
- NO_INTERVENTION
- label
- Control Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 7 Years
Show eligibility criteria text
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.
References
Publications (0)
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