NAO Robot in Pediatric Occupational Therapy

NCT ID: NCT07283211

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2025-06-02

Brief 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

Cerebral Palsy (CP); Activities of Daily Living

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Group - Occupational Therapy With and Without Social Robot Support

This single-group arm includes all participants, who receive two sequential phases of occupational therapy. In Phase 1, children receive routine occupational therapy sessions delivered by a licensed occupational therapist. After a 2-week interval, participants enter Phase 2, during which they receive the same occupational therapy activities supplemented with robot-assisted interaction using the NAO humanoid robot. All participants experience both phases in the same order, and no randomization or group allocation is performed.

Group Type: EXPERIMENTAL

Occupational Therapy Intervention

Intervention Type: OTHER

Routine 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.

NAO Robot-Assisted Occupational Therapy

Intervention Type: OTHER

NAO 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).

Interventions

Occupational Therapy Intervention

Routine 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.

Intervention Type: OTHER

NAO Robot-Assisted Occupational Therapy

NAO 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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children aged 5-15 years
• Diagnosis of unilateral spastic cerebral palsy
• Classified as Level I-III according to the Gross Motor Function Classification System (GMFCS)
• Classified as Level 1-3 on the Manual Ability Classification System (MACS)
• Level 0-2 on the Modified Ashworth Scale, indicating mild to moderate spasticity

Exclusion Criteria

• History of upper extremity orthopedic surgery within the past year
• Presence of epileptic symptoms
• Receipt of botulinum toxin treatment within the last six months

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: collaborator

Yeditepe University

OTHER

Sponsor Role: collaborator

Ankara Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Hilal Bostancı Seçkin

LECTURER

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Medipol University

Altindağ, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

123E355

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E-10840098-772.02-30

Identifier Type: -

Identifier Source: org_study_id