ROBO-PAWS: Robot-Dog-Assisted Walking

NCT07603180 | Not Yet Recruiting

• 1 other identifier: KOCUNV
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Sleep Quality; Fatigue; Quality of Life

Keywords

sleep quality; fatigue; children; cancer

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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.

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

Secondary Outcomes (1)

• Fatigue

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

Study Arms (2)

ROBO-PAWS Group

EXPERIMENTAL

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.

Device: Robot-Dog-Assisted Walking

Control Group

NO INTERVENTION

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.

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

ROBO-PAWS Group

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koç University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Fatigue; Neoplasms

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Remziye Semerci Şahin, PhD

CONTACT

+90 535 011 2821; remziyesemerci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be blinded to group allocation in order to reduce assessment and analysis bias. Due to the nature of the intervention, participants and intervention providers cannot be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teachind and Research Assistant

Model Details: This study will be conducted as a parallel-group, two-arm pilot randomized controlled trial with blinded outcome assessors/data analysts.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share