- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07283211
NAO Robot in Pediatric Occupational Therapy (NAO Robot)
Using a NAO Robot to Enhance Occupational Therapy for Children With Cerebral Palsy
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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
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Altindağ, Ankara, Turkey (Türkiye), 06050
- Ankara Medipol University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Participants receive the same core occupational therapy program as in Phase 1, supplemented with robot-mediated interaction using the NAO humanoid robot (SoftBank Robotics).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of Upper Extremity Skills Test (QUEST)
Time Frame: 20 minutes
|
20 minutes
|
|
Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame: 10 minutes
|
10 minutes
|
|
Bimanual Fine Motor Function
Time Frame: 10 minutes
|
10 minutes
|
|
Canadian Occupational Performance Measure
Time Frame: 10 minutes
|
10 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-30
- 123E355 (Other Grant/Funding Number: The Scientific and Technological Research Council of Turkey (TUBITAK 1002))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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