NCT07612371

Brief Summary

The aim of this study is to evaluate the effects of action observation therapy and motor imagery methods, provided in addition to a conventional physiotherapy and rehabilitation program, on gross motor function, upper and lower extremity functional skills, and quality of life in children with cerebral palsy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
May 2026Oct 2026

First Submitted

Initial submission to the registry

May 15, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 15, 2026

Last Update Submit

May 23, 2026

Conditions

Keywords

motor imageryMirror Neuronsquality of lifeCognitive Training

Outcome Measures

Primary Outcomes (1)

  • ABILHAND-Kids

    Manual ability in daily activities assessed using the ABILHAND-Kids questionnaire for children with cerebral palsy (measured as logit score using Rasch analysis). ABILHAND-Kids evaluates the child's perceived difficulty in performing daily bimanual activities, such as dressing (buttons, zippers), eating with utensils, using scissors or pencils, opening containers, handling small objects. Contains a list of everyday manual tasks Each item is rated based on difficulty: Impossible, difficult, easy. Higher scores indicate better manual ability. Time Frame: 8 weeks

    0th week; 8th week

Secondary Outcomes (6)

  • Pediatric Quality of Life Inventory (PedsQL)

    0th week; 8th week

  • Jebsen-Taylor Hand Function Test

    0th week; 8th week

  • The Child and Adolescent Scale of Participation (CASP)

    0th week; 8th week

  • Gross Motor Function Measure (GMFM)

    0th week; 8th week

  • Timed Up and Go Test

    0th week; 8th week

  • +1 more secondary outcomes

Study Arms (3)

Motor Imagery Group

ACTIVE COMPARATOR

Mental imagery practice will be applied in addition to conventional physiotherapy. A total of 10 movements supporting activities of daily living, including unimanual and bimanual upper extremity activities, walking, and balance activities, will be practiced from both first-person and third-person perspectives. The intervention will be administered for 50 minutes per session, twice a week, for 8 weeks. The intervention protocol will consist of 20 minutes of conventional physiotherapy followed by 30 minutes of motor imagery practice.

Other: motor imagery

Action Observation Therapy Group:

ACTIVE COMPARATOR

Action observation therapy will be applied in adition to conventional physiotherapy. A total of 10 movements supporting activities of daily living, including unimanual and bimanual upper extremity activities, walking, and balance activities, will be practiced. In action observation therapy, after participants observe the movement (observation phase), they will be asked to imitate the observed movement (execution phase). The intervention will be administered for 50 minutes per session, twice a week, for 8 weeks. The intervention protocol will consist of 20 minutes of conventional physiotherapy followed by 30 minutes of action observation therapy.

Other: Action observation therapy

Conventional physiotherapy group

ACTIVE COMPARATOR

Conventional physiotherapy training will be structured according to the child's symptoms and needs, and will consist of stretching, strengthening, normal walking training, postural control training, and weight-bearing training in different positions (sitting, standing, side-lying, prone).

Other: Conventional physiotherapy group

Interventions

Participants will receive treatment for 16 sessions in total, with 2 sessions per week for 8 weeks. Each session will last 50 minutes. The motor imagery practice will consist of a total of 10 movements including unimanual and bimanual, walking and balance activities, and will be performed by participants from both first-person and third-person perspectives. Balance activities: * Single-leg standing balance * Sit and stand up with your arms crossed in front of you while sitting in the chair. Walking activities: * The child gets up from the chair without support, walks 3 meters, then returns and sits back down in the chair * Walking sideways and backward on different surfaces Bimauel upper extremity activities * Putting on a blouse * Putting on and zipping up/down a dress with a front zipper. * Putting on shoes and tying the laces. Unimanual upper extremity activities * Taking food from the plate with a spoon and putting it in the mouth * Combing hair * Holding the doorknob and opening

Motor Imagery Group

Participants will receive treatment for 16 sessions in total, with 2 sessions per week for 8 weeks. Each session will last 50 minutes. Action observation therapy will consist of a total of 10 movements including unimanual and bimanual, walking and balance activities. After participants observe the movement (observation phase), they are asked to imitate the movement they observed (execution phase). Balance activities: * Single-leg standing balance * Sit and stand up with your arms crossed in front of you while sitting in the chair. Walking activities: * The child gets up from the chair without support, walks 3 meters, then returns and sits back down in the chair * Walking sideways and backward on different surfaces Bimauel upper extremity activities * Putting on a blouse * Putting on and zipping up/down a dress with a front zipper. * Putting on shoes and tying the laces. Unimanual upper extremity activities * Taking food from the plate with a spoon and putting it in the mouth

Action Observation Therapy Group:

Participants will receive treatment for 16 sessions in total, with 2 sessions per week for 8 weeks. Each session will last 50 minutes. Conventional physiotherapy training will be structured according to the child's symptoms and needs, and will consist of stretching, strengthening, normal walking training, postural control training, and weight-bearing training in different positions (sitting, standing, side-lying, prone).

Conventional physiotherapy group

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Being between 7 and 16 years of age
  • Having a diagnosis of unilateral cerebral palsy made by a pediatric neurologist
  • Being classified at levels I-II of the Gross Motor Function Classification System (GMFCS)
  • Scoring above 24 on the Mini-Mental State Examination for Children
  • Having no cognitive impairments (i.e., possessing an appropriate cognitive level to follow task instructions)
  • Willingness to participate in the study (child and family)
  • Being classified at levels I-III of the Manual Ability Classification System (MACS) -Being classified at levels I-III of the Communication Function Classification System (CFCS) -

You may not qualify if:

  • Children with uncontrolled seizures
  • Children who have received motor imagery training or action observation therapy within the last 6 months
  • Children with contractures
  • Children with severe visual and/or hearing impairments
  • Being classified at levels III, IV, or V according to the GMFCS
  • Scoring below 24 on the Mini-Mental State Examination for Children
  • Being classified at levels IV-V of the Manual Ability Classification System (MACS)
  • Having undergone orthopedic surgery or botulinum toxin (Botox) treatment within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kurtkoy Ozel Egitim ve Rehabilitasyon Merkezi

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • Steenbergen B, Jongbloed-Pereboom M, Spruijt S, Gordon AM. Impaired motor planning and motor imagery in children with unilateral spastic cerebral palsy: challenges for the future of pediatric rehabilitation. Dev Med Child Neurol. 2013 Nov;55 Suppl 4:43-6. doi: 10.1111/dmcn.12306.

    PMID: 24237279BACKGROUND
  • Sgandurra G, Ferrari A, Cossu G, Guzzetta A, Fogassi L, Cioni G. Randomized trial of observation and execution of upper extremity actions versus action alone in children with unilateral cerebral palsy. Neurorehabil Neural Repair. 2013 Nov-Dec;27(9):808-15. doi: 10.1177/1545968313497101. Epub 2013 Jul 25.

    PMID: 23886886BACKGROUND
  • Alamer A, Melese H, Adugna B. Effectiveness of Action Observation Training on Upper Limb Motor Function in Children with Hemiplegic Cerebral Palsy: A Systematic Review of Randomized Controlled Trials. Pediatric Health Med Ther. 2020 Sep 15;11:335-346. doi: 10.2147/PHMT.S266720. eCollection 2020.

    PMID: 32982541BACKGROUND
  • Demeco A, Molinaro A, Ambroggi M, Frizziero A, Fazzi E, Costantino C, Buccino G. Cognitive approaches in the rehabilitation of upper limbs function in children with cerebral palsy: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2024 Jun;60(3):445-457. doi: 10.23736/S1973-9087.24.08288-1. Epub 2024 Mar 21.

    PMID: 38512713BACKGROUND
  • Shin YK, Lee DR, Hwang HJ, You SJ, Im CH. A novel EEG-based brain mapping to determine cortical activation patterns in normal children and children with cerebral palsy during motor imagery tasks. NeuroRehabilitation. 2012;31(4):349-55. doi: 10.3233/NRE-2012-00803.

    PMID: 23232157BACKGROUND
  • Buccino G, Molinaro A, Ambrosi C, Arisi D, Mascaro L, Pinardi C, Rossi A, Gasparotti R, Fazzi E, Galli J. Action Observation Treatment Improves Upper Limb Motor Functions in Children with Cerebral Palsy: A Combined Clinical and Brain Imaging Study. Neural Plast. 2018 Jul 4;2018:4843985. doi: 10.1155/2018/4843985. eCollection 2018.

    PMID: 30123250BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hasan K. Alptekin, Prof. Dr.

    Bahçeşehir University

    STUDY CHAIR
  • Pelin Pisirici, Assoc. Prof.

    Bahçeşehir University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups with a conventional therapy control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2026

First Posted

May 28, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

IPD will be made available upon reasonable request after publication of the study results. Requests will be evaluated and approved by the principal investigator to ensure that the proposed use is methodologically sound and in accordance with ethical and institutional regulations. Data will be shared for academic and non-commercial research purposes only.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of the study results
Access Criteria
De-identified individual participant data will be available upon reasonable request. Requests will be reviewed and approved by the principal investigator for non-commercial academic research purposes only.

Locations