NCT07283211

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
Last Updated

January 23, 2026

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

December 2, 2025

Last Update Submit

January 22, 2026

Conditions

Keywords

occupational therapycerebral palsysocial robots

Outcome Measures

Primary Outcomes (4)

  • Quality of Upper Extremity Skills Test (QUEST)

    20 minutes

  • Pediatric Evaluation of Disability Inventory (PEDI)

    10 minutes

  • Bimanual Fine Motor Function

    10 minutes

  • Canadian Occupational Performance Measure

    10 minutes

Study Arms (1)

Single Group - Occupational Therapy With and Without Social Robot Support

EXPERIMENTAL

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.

Other: Occupational Therapy InterventionOther: NAO Robot-Assisted Occupational Therapy

Interventions

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.

Single Group - Occupational Therapy With and Without Social Robot Support

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).

Single Group - Occupational Therapy With and Without Social Robot Support

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Altindağ, Ankara, 06050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 15, 2025

Study Start

January 2, 2024

Primary Completion

July 2, 2024

Study Completion

June 2, 2025

Last Updated

January 23, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Due to the inclusion of pediatric participants and the sensitive nature of the clinical data, individual participant data will not be shared.

Locations