Clinical trial NCT06948227: Effect Of Social Robots In Cerebral Palsy
Official title: Effect Of Social Robots On Motivation And Participation In Activities Of Daily Life Training In Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Keywords: cerebral palsy
nao
occupational therapy
Lead sponsor: Medipol University
Sponsor class: OTHER
Collaborators: name: Yeditepe University
First posted: 2025-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups as Daily Living Activities (ADL) Training Program and Social Robot Application Group.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the motivation of the participants, upper extremity skills and daily living activity skills of classical occupational therapy practices in children diagnosed with cerebral palsy with therapy practices using Social Robot Nao in addition to classical occupational therapy practices.

Detailed description: Social Robots are technological developments that are used very frequently, especially in sectors such as education, health and industry, and whose use is increasing day by day, providing services by providing human-robot interaction in various application areas. This study aims to support upper extremity skills in children diagnosed with cerebral palsy through interaction, to increase participation by teaching daily living activities, and to examine the effects of this therapy in the long term. With the social robot, occupational therapists and physiotherapists will be prevented from suffering from burnout syndrome by increasing their efficiency in therapy. One of the aims is to increase motivation in therapy through interaction with the social robot and to maintain the positive effects of therapy in the long term.

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.

Eligibility criteria: Inclusion Criteria:

* Children with levels I-III according to the Gross Motor Function Classification System (GMFCS),
* 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 not had any orthopedic surgery affecting the upper extremity in the last year
* Children who have any epileptic findings
* Children who have received botox in the last 6 months will be excluded from the study.

Primary outcomes:
measure: Quality of Upper Extremity Skills Test (QUEST)
timeFrame: six weeks
measure: Bimanual Fine Motor Function (BIMF)
timeFrame: six weeks
Secondary outcomes:
measure: Canadian Activity Performance Scale (COPM)
timeFrame: six weeks
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: six weeks
measure: Pediatric Motivation Scale (PMS)
timeFrame: six weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dilbade Special Education Rehabilitation Center
state: Eyupsultan
Study officials:
affiliation: Medipol University
name: Devrim Tarakcı, Associate Professor
role: STUDY_CHAIR
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