Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-05-01
2025-10-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
NAO Robot in Pediatric Occupational Therapy
NCT07283211
The Effects of Upper Extremity Robotic Rehabilitation in Children With Spastic Hemiparetic Cerebral Palsy
NCT06352762
Effectiveness of Robot-Assisted Upper Extremity Rehabilitation in Children With Cerebral Palsy
NCT05883488
Effect of Multidimensional Trunk Training in Children With Cerebral Palsy
NCT07034872
Tele-rehabilitation in Children With Cerebral Palsy in the Covid-19 Pandemic
NCT04896840
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Cerebral palsy is defined as a permanent movement and posture disorder that occurs with a non-progressive lesion in the developing fetal and newborn brain and causes activity limitation. Cerebral Palsy is classified as spastic, dyskinetic, ataxic according to movement disorder, and as diplegia, quadriplegia, triplegia and hemiplegia according to the affected body part. In hemiplegic type cerebral palsy, which is the most common type in which one side of the body is used more than the other in classification according to body part, the upper extremity is generally affected more than the lower extremity. In the classification according to movement disorders, the most common one is unilateral spastic cerebral palsy, which negatively affects the ability to perform daily living activities, especially due to difficulties in grasping skills. Shoulder adduction-internal rotation contracture, elbow flexion contracture, wrist flexion-pronation contracture are the most common symptoms, especially in the upper extremity, but factors such as the patient's existing spasticity, affected muscle and age may cause changes in symptoms. Therefore, upper extremity movement analyzes are complex. Children with cerebral palsy often have difficulty with activities that the investigators need in daily life, such as grasping and manipulating objects. This difficulty occurs very often, especially when doing activities that require fine motor skills and the use of both hands (bimanual actions). The aforementioned bimanual actions are important in performing daily living activities such as buttoning shirts, tying shoelaces, opening bottle caps, and using cutlery, which require advanced fine motor skills and a large number of tasks and variety.
In recent years, new technological advances in walking, balance and upper extremity skill rehabilitation have been made available to patients with cerebral palsy. One of these is the social robot Nao, which teaches upper extremity motor functions required for daily living activities in children with cerebral palsy through imitation, and is known to be used successfully in rehabilitation. Social robots, which provide social communication by interacting with users, have been frequently used as assistants in the rehabilitation process in recent years. These social robots benefit from their physical, social and emotional characteristics to both progress in therapies and maintain commitment as well as effective communication. Thanks to these characteristics, therapies are long-lasting. Social robots are specifically designed to sustain and promote the effectiveness of therapies and education in children. The social robot Nao is more affordable than other types of robots and has a variety of functionality, making it the most frequently preferred choice in therapies. There are studies in the literature on the use of the social robot Nao in therapies to improve motor skills in daily life activities in children diagnosed with cerebral palsy. It has also been used previously in upper extremity rehabilitation and has proven to be a tool in teaching activities through imitation.
Although there are many studies in the literature on the use of social robots in rehabilitation, the examination of their effects on motivation and participation in these rehabilitation programs has been insufficient. The aim of this study is to teach upper extremity skills to children diagnosed with cerebral palsy through imitation activities using a social robot and to examine the effects on their motivation and participation. This study is original in that it adds a social robot to occupational therapy sessions and examines the effects of participation and motivation on children with cerebral palsy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Social Robot Application Group
The negatively affected characteristics of children with Cerebral Palsy will be determined by the occupational therapist together with their families. Activities that they cannot do in daily life will be implemented using the Social Robot Nao within the occupational therapy application to improve their upper extremity skills and motivation.
Social Robot Application
The basic daily life activities that the Social Robot can perform, such as eating and brushing teeth, and the ball throwing activity that affects their participation, will be coded into the robot by engineers. 1. The evaluations will be applied as in the other group, and occupational therapy sessions for upper extremity skills will be applied with the Social Robot Nao accompanied by a therapist for 6 weeks. In this group, the robot will show the selected activities to the children according to the activity application steps during the session and then ask the child to apply them. The verbal feedback that the Social Robot Nao will use will be determined and applied by the therapist. At the end of the 6th week, the second evaluations will be made and the 6-week developments of the participants in this group will be analyzed. Each session will be applied once a week for 40 minutes.
Daily Living Activities (ADL) Training Program Group
The negatively affected characteristics of children with cerebral palsy will be determined by the occupational therapist together with their families. Occupational therapy will be applied to the activities they cannot do in daily life by developing their upper extremity skills and motivation.
Daily Living Activities (ADL) Training Program
After the 1st assessment, activities that the investigators frequently use in daily life such as eating and brushing our teeth and activities that are appropriate for the age group of the participants and that affect their participation such as throwing a ball or playing games will be implemented with the therapist for 6 weeks. During the session, the therapist will provide practical training so that the participants can do the activities correctly and will provide a demonstration of the activity, observe whether the child compensates while performing the movements during all these activity steps and will make corrections for the movements that he/she compensates for. At the same time, the therapist will give reinforcing verbal affect for the activity skills that the participants do correctly in order to increase their motivation during the session. The 2nd Assessment will be made at the end of the 6th week in order to analyze the change during the 6-week period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Daily Living Activities (ADL) Training Program
After the 1st assessment, activities that the investigators frequently use in daily life such as eating and brushing our teeth and activities that are appropriate for the age group of the participants and that affect their participation such as throwing a ball or playing games will be implemented with the therapist for 6 weeks. During the session, the therapist will provide practical training so that the participants can do the activities correctly and will provide a demonstration of the activity, observe whether the child compensates while performing the movements during all these activity steps and will make corrections for the movements that he/she compensates for. At the same time, the therapist will give reinforcing verbal affect for the activity skills that the participants do correctly in order to increase their motivation during the session. The 2nd Assessment will be made at the end of the 6th week in order to analyze the change during the 6-week period.
Social Robot Application
The basic daily life activities that the Social Robot can perform, such as eating and brushing teeth, and the ball throwing activity that affects their participation, will be coded into the robot by engineers. 1. The evaluations will be applied as in the other group, and occupational therapy sessions for upper extremity skills will be applied with the Social Robot Nao accompanied by a therapist for 6 weeks. In this group, the robot will show the selected activities to the children according to the activity application steps during the session and then ask the child to apply them. The verbal feedback that the Social Robot Nao will use will be determined and applied by the therapist. At the end of the 6th week, the second evaluations will be made and the 6-week developments of the participants in this group will be analyzed. Each session will be applied once a week for 40 minutes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Children with levels 1-3 according to the Manual Ability Classification System (MACS),
* Children with levels 0-2 according to the Modified Ashworth Scale,
* Children with levels 1-2 according to the Communication Function Classification System (CFCS),
* Children between the ages of 4-12,
* Children with cerebral palsy will be included in the study.
Exclusion Criteria
* Children who have any epileptic findings
* Children who have received botox in the last 6 months will be excluded from the study.
4 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yeditepe University
OTHER
Medipol University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hale Nur Baş
Occupational Therapist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Devrim Tarakcı, Associate Professor
Role: STUDY_CHAIR
Medipol University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dilbade Special Education Rehabilitation Center
Istanbul, Eyupsultan, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
Gonzalez JC, Pulido JC, Fernandez F, Suarez-Mejias C. Planning, execution and monitoring of physical rehabilitation therapies with a robotic architecture. Stud Health Technol Inform. 2015;210:339-43.
Calderita LV, Manso LJ, Bustos P, Suarez-Mejias C, Fernandez F, Bandera A. THERAPIST: Towards an Autonomous Socially Interactive Robot for Motor and Neurorehabilitation Therapies for Children. JMIR Rehabil Assist Technol. 2014 Oct 7;1(1):e1. doi: 10.2196/rehab.3151.
Amirova A, Rakhymbayeva N, Yadollahi E, Sandygulova A, Johal W. 10 Years of Human-NAO Interaction Research: A Scoping Review. Front Robot AI. 2021 Nov 19;8:744526. doi: 10.3389/frobt.2021.744526. eCollection 2021.
Liao YH, Lin TY, Wu CC, Shih YN. Can occupational therapy manpower be replaced with social robots in a singing group during COVID-19? Work. 2021;68(1):21-26. doi: 10.3233/WOR-205096.
Cortes-Perez I, Gonzalez-Gonzalez N, Peinado-Rubia AB, Nieto-Escamez FA, Obrero-Gaitan E, Garcia-Lopez H. Efficacy of Robot-Assisted Gait Therapy Compared to Conventional Therapy or Treadmill Training in Children with Cerebral Palsy: A Systematic Review with Meta-Analysis. Sensors (Basel). 2022 Dec 16;22(24):9910. doi: 10.3390/s22249910.
Cacioppo M, Loos A, Lempereur M, Brochard S. Bimanual movements in children with cerebral palsy: a systematic review of instrumented assessments. J Neuroeng Rehabil. 2023 Feb 27;20(1):26. doi: 10.1186/s12984-023-01150-7.
Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18.
Rozaire J, Paquin C, Henry L, Agopyan H, Bard-Pondarre R, Naaim A, Duprey S, Chaleat-Valayer E. A systematic review of instrumented assessments for upper limb function in cerebral palsy: current limitations and future directions. J Neuroeng Rehabil. 2024 Apr 16;21(1):56. doi: 10.1186/s12984-024-01353-6.
Makki D, Duodu J, Nixon M. Prevalence and pattern of upper limb involvement in cerebral palsy. J Child Orthop. 2014 May;8(3):215-9. doi: 10.1007/s11832-014-0593-0. Epub 2014 May 14.
Gutterman J, Gordon AM. Neural Correlates of Impaired Grasp Function in Children with Unilateral Spastic Cerebral Palsy. Brain Sci. 2023 Jul 21;13(7):1102. doi: 10.3390/brainsci13071102.
Chiu HC, Ada L. Constraint-induced movement therapy improves upper limb activity and participation in hemiplegic cerebral palsy: a systematic review. J Physiother. 2016 Jul;62(3):130-7. doi: 10.1016/j.jphys.2016.05.013. Epub 2016 Jun 17.
Paul S, Nahar A, Bhagawati M, Kunwar AJ. A Review on Recent Advances of Cerebral Palsy. Oxid Med Cell Longev. 2022 Jul 30;2022:2622310. doi: 10.1155/2022/2622310. eCollection 2022.
Hunt M, Everaert L, Brown M, Muraru L, Hatzidimitriadou E, Desloovere K. Effectiveness of robotic exoskeletons for improving gait in children with cerebral palsy: A systematic review. Gait Posture. 2022 Oct;98:343-354. doi: 10.1016/j.gaitpost.2022.09.082. Epub 2022 Sep 26.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
123E355
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IMU-ERG-HNB-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.