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Completed

NCT Number: NCT07283211

NAO Robot in Pediatric Occupational Therapy

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).

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Key information

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Medipol University

Altindağ, Ankara, 06050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occupational therapy intervention

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

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).

Primary outcomes

  1. Quality of Upper Extremity Skills Test (QUEST)

    Time frame: 20 minutes

  2. Pediatric Evaluation of Disability Inventory (PEDI)

    Time frame: 10 minutes

  3. Bimanual Fine Motor Function

    Time frame: 10 minutes

  4. Canadian Occupational Performance Measure

    Time frame: 10 minutes

Sponsors and collaborators

Lead sponsor

Ankara Medipol University

Other

Collaborators

  • Medipol University
  • Yeditepe University

Registry information

Official study title

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

Acronym: NAO Robot

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 15, 2025
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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