Cerebral Palsy (CP)NAO RobotNCT07283211
NAO Robot in Pediatric Occupational Therapy
A study testing Occupational Therapy Intervention and NAO Robot-Assisted Occupational Therapy in people with Cerebral Palsy (CP) and Activities of Daily Living, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy (CP), Activities of Daily Living
- What is being tested?
- Occupational Therapy Intervention and NAO Robot-Assisted Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 2 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- History of upper extremity orthopedic surgery within the past year
- Presence of epileptic symptoms
- Receipt of botulinum toxin treatment within the last six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Medipol University
Altindağ, Ankara, 06050
About this study
Official title: 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).
Read the 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
- Being tested
- Occupational Therapy Intervention, NAO Robot-Assisted Occupational Therapy
- Keywords
- occupational therapy, cerebral palsy, social robots
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Therapy InterventionOther
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 TherapyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Occupational Therapy Intervention; Other: NAO Robot-Assisted Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Upper Extremity Skills Test (QUEST)
Measured: 20 minutes
Pediatric Evaluation of Disability Inventory (PEDI)
Measured: 10 minutes
Bimanual Fine Motor Function
Measured: 10 minutes
Canadian Occupational Performance Measure
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start2 Jan 2024
- Primary completion2 Jul 2024
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University, Yeditepe University
- Responsible party
- Principal investigator, Hilal Bostancı Seçkin, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283211
- Sponsor's protocol ID
- E-10840098-772.02-30
- Other IDs
- 123E355
- Acronym
- NAO Robot
- Status last verified
- Nov 2025
- First submitted
- 2 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the inclusion of pediatric participants and the sensitive nature of the clinical data, individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a NAO Robot to Enhance Occupational Therapy for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07283211
- Acronym / sponsor ID
- NAO Robot / E-10840098-772.02-30
- Conditions
- Cerebral Palsy (CP), Activities of Daily Living
- Keywords
- occupational therapy, cerebral palsy, social robots
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Collaborators
- Medipol University, Yeditepe University
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group - Occupational Therapy With and Without Social Robot Support | Experimental | Other: Occupational Therapy Intervention, Other: NAO Robot-Assisted Occupational TherapyThis 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. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- History of upper extremity orthopedic surgery within the past year
- Presence of epileptic symptoms
- Receipt of botulinum toxin treatment within the last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational 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. | Other | Single Group - Occupational Therapy With and Without Social Robot Support |
| NAO 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). | Other | Single Group - Occupational Therapy With and Without Social Robot Support |
Primary outcome
Quality of Upper Extremity Skills Test (QUEST)
Time frame: 20 minutes
Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: 10 minutes
Bimanual Fine Motor Function
Time frame: 10 minutes
Canadian Occupational Performance Measure
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No. Due to the inclusion of pediatric participants and the sensitive nature of the clinical data, individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy Intervention and NAO Robot-Assisted Occupational Therapy in people with Cerebral Palsy (CP) and Activities of Daily Living, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Upper Extremity Skills Test (QUEST) (time frame: 20 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.