Clinical Trials Directory

Trials / Completed

CompletedNCT07283211

NAO Robot in Pediatric Occupational Therapy

Using a NAO Robot to Enhance Occupational Therapy for Children With Cerebral Palsy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Ankara Medipol University · Academic / Other
Sex
All
Age
5 Years – 15 Years
Healthy volunteers
Not accepted

Summary

Cerebral Palsy (CP) is a non-progressive neurological disorder that affects movement and posture, often impairing upper extremity function and daily activity performance. Technological tools, such as social robots, have shown promise in supporting rehabilitation. This study investigated the effects of NAO robot-assisted therapy on functional performance, motivation, and emotional states in children with unilateral CP. Sixteen children participated in a 14-week intervention, which included 12 weeks of task-oriented therapy. In six of those weeks, sessions incorporated the NAO robot, which simulated three daily activities identified using the Canadian Occupational Performance Measure (COPM) and offered motivational feedback. Emotional responses were tracked using the Empatica E4 wristband, measuring blood volume pulse (BVP), electrodermal activity (EDA), and skin temperature (ST).

Detailed description

This single-group interventional study investigated the effect of adding the social humanoid robot NAO to occupational therapy sessions on upper extremity function, hand skills, and motivation in children with unilateral spastic cerebral palsy (CP). Sixteen children aged 5-15 years, classified as GMFCS I-III, MACS 1-3, CFCS 1-2, and MAS 0-2, participated. The study consisted of two sequential 6-week phases: Phase 1: Routine occupational therapy sessions (40 minutes each). Phase 2: Routine occupational therapy supplemented with NAO robot-assisted activities (same duration). Sessions targeted functional tasks identified using the Canadian Occupational Performance Measure (COPM), such as eating, throwing a ball, and brushing teeth. Upper extremity function was assessed with the Quality of Upper Extremity Skills Test (QUEST); functional abilities with PEDI; activity limitations and bimanual hand use with GMFCS and BFMF; and occupational performance and satisfaction with COPM. Physiological signals (blood volume pulse, electrodermal activity, and skin temperature) were recorded using the Empatica E4 wristband to assess children's motivation and emotional responses during sessions. Data were analyzed using appropriate statistical methods, including t-tests, Mann-Whitney U, Friedman test, and Wilcoxon signed-rank tests with Bonferroni correction.

Conditions

Interventions

TypeNameDescription
OTHEROccupational Therapy InterventionRoutine Occupational Therapy. Participants receive standard occupational therapy sessions delivered by a licensed pediatric occupational therapist. Sessions include individualized therapeutic activities targeting fine motor skills, bilateral coordination, sensory processing, activities of daily living (ADL) training, and play-based functional tasks.
OTHERNAO Robot-Assisted Occupational TherapyNAO Robot-Assisted Occupational Therapy. Participants receive the same core occupational therapy program as in Phase 1, supplemented with robot-mediated interaction using the NAO humanoid robot (SoftBank Robotics).

Timeline

Start date
2024-01-02
Primary completion
2024-07-02
Completion
2025-06-02
First posted
2025-12-15
Last updated
2026-01-23

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07283211. Inclusion in this directory is not an endorsement.