Effect Of Social Robots In Cerebral Palsy

NCT06948227 | Not Yet Recruiting

• 2 other identifiers: IMU-ERG-HNB-01123E355
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy (CP)

Keywords

cerebral palsy; nao; occupational therapy

Outcome Measures

Primary Outcomes (2)

• Quality of Upper Extremity Skills Test (QUEST)

  This scale will be applied to analyze the changes in the upper extremity skills of the participants. In this scale, the investigators put a check mark on the skill that the participant can do. The investigators cross out the skill that the participant cannot do, and write NT for the skill that cannot be tested. This scale has dissociated movements, grasps, wight bearing and protective extansion.The higher the total score, the more advanced the skill. There is a separate calculation method for each subsection. In the final stage, to calculate the total score of the test, the scores obtained in each subsection are added up and divided by the number of sections tested \[ \[(Score A-50)x2 + (Score B-50)x2 + (Score C-50)x2 + (Score D-50)x2\] /4 \].

  six weeks

• Bimanual Fine Motor Function (BIMF)

  This scale will be applied to analyze the changes in the participants' fine motor skills. In this scale, fine motor skills are determined as 5 levels. Level I= One hand: manipulates without restrictions. The other hand: manipulates without restrictions or limitations in more advanced fine motor skills Level II= (a) One hand: manipulates without restrictions. The other hand: only ability to grasp or hold (b) Both hands: limitations in more advanced fine motor skills Level III= (a) One hand: manipulates without restrictions. The other hand no functional ability (b) One hand: limitations in more advanced fine motor skills. The other hand: only ability to grasp or worse Level IV= (a) Both hands: only ability to grasp (b) One hand: only ability to grasp. The other hand: only ability to hold or worse Level V= Both hands: only ability to hold or worse

  six weeks

Secondary Outcomes (3)

• Canadian Activity Performance Scale (COPM)

  six weeks

• Pediatric Evaluation of Disability Inventory (PEDI)

  six weeks

• Pediatric Motivation Scale (PMS)

  six weeks

Study Arms (2)

Social Robot Application Group

EXPERIMENTAL

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.

Other: Social Robot Application

Daily Living Activities (ADL) Training Program Group

ACTIVE COMPARATOR

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.

Other: Daily Living Activities (ADL) Training Program

Interventions

Daily Living Activities (ADL) Training Program OTHER

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.

Daily Living Activities (ADL) Training Program Group

Social Robot Application OTHER

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.

Social Robot Application Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead
• Yeditepe University: collaborator

Study Sites (1)

Dilbade Special Education Rehabilitation Center

Istanbul, Eyupsultan, 34055, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  PMID: 17370477 BACKGROUND

• 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.

  PMID: 25991162 BACKGROUND

• 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.

  PMID: 28582242 BACKGROUND

• 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.

  PMID: 34869613 BACKGROUND

• 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.

  PMID: 33459684 BACKGROUND

• 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.

  PMID: 36560281 BACKGROUND

• 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.

  PMID: 36849971 BACKGROUND

• 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.

  PMID: 19451190 BACKGROUND

• 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.

  PMID: 38622731 BACKGROUND

• 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.

  PMID: 24824566 BACKGROUND

• 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.

  PMID: 37509032 BACKGROUND

• 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.

  PMID: 27323932 BACKGROUND

• 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.

  PMID: 35941906 BACKGROUND

• 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.

  PMID: 36306544 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Activities of Daily Living

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Devrim Tarakcı, Associate Professor

  Medipol University

  STUDY CHAIR

Central Study Contacts

Hale Nur Baş, Occupational Therapist

CONTACT

+905434283853; erg.halenurbas@outlook.com

Devrim Tarakcı, Associate Professor

CONTACT

+905322052282; dtarakci@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist

Model Details: Two groups as Daily Living Activities (ADL) Training Program and Social Robot Application Group.

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 29, 2025
• Study Start: May 1, 2025
• Primary Completion: July 15, 2025
• Study Completion: October 25, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)