- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07612371
Effects of Motor Imagery and Action Observation on Motor Function in Unilateral Cerebral Palsy
Investigation of the Effects of Motor Imagery and Action Observation Therapy on Gross Motor Function, Upper Extremity Functional Skills, Activity, and Participation in Children With Unilateral Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In children with unilateral cerebral palsy (CP), the ability to perform various hand activities is reduced. Sensory and motor impairments observed in the affected upper extremity are the main causes of functional limitations. These impairments restrict the ability to perform simple activities of daily living such as dressing, tooth brushing, hair combing, feeding, and playing, and also lead to limitations in activity and participation within a broader social context. Therefore, one of the primary goals of neurological rehabilitation in this population is to promote the effective use of the affected upper extremity in daily tasks by improving its capacity and performance, and to support the child's independence in daily living activities by enhancing skills and increasing participation in activities. However, approximately 75% of children with unilateral CP continue to demonstrate motor impairments in activities of daily living even when they participate in a comprehensive rehabilitation program including conventional physical therapy, orthotic use, and spasticity management. There is a need for new rehabilitation programs aimed at enhancing the effects of traditional treatments, which mainly involve motor interventions.
In CP rehabilitation, it is recommended to integrate motor training with environmental enrichment and to increase environmental stimuli in order to enhance task performance. These approaches are based on the implementation of real-life activity-based tasks through active movements, with high intensity and individualized goals. In this way, neuroplasticity is supported through attention, motivation, and intensive repetition. Furthermore, it is recommended that activity- and task-oriented motor training be complemented with cognitive interventions such as action observation therapy, motor imagery, and mirror therapy, which combine motor and cognitive rehabilitation approaches.
Motor imagery is the mental simulation of movement without any overt motor action and refers to the capacity to generate kinesthetic representations of motor actions. Motor imagery selectively stimulates the cognitive aspect of motor behavior and is considered a prerequisite for motor planning processes. Recent studies have shown that despite motor deficits related to movement execution in children with CP, the ability to imagine movements may remain preserved. Therefore, interventions focusing on motor planning and imagery have emerged as potential treatment options for CP. However, the number of studies investigating the effectiveness of motor imagery in the CP population is quite limited, and well-designed studies examining the effectiveness of motor imagery training in individuals with CP are needed.
Action Observation Therapy (AOT) is known to be a cognitive intervention used to improve various motor skills in patients with motor impairments. From a rehabilitation perspective, the mirror neuron system plays a major role in the human capacity to learn through imitation. Based on the mirror neuron system, action observation consists of systematically and repeatedly observing actions followed by the reproduction of the observed actions. Findings from studies using AOT have indicated that AOT improves activities of daily living and has been proposed as a novel neurophysiological approach focused on motor learning in CP rehabilitation. Nevertheless, well-designed studies investigating the effectiveness of action observation training in individuals with CP are still needed.
The aim of this study is to evaluate the effects of Action Observation Therapy and motor imagery methods, provided in addition to conventional rehabilitation, on gross motor function, upper and lower extremity functional skills, and quality of life in children with CP.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Betul Unal
- Phone Number: +905314070105
- Email: betul.unal1@bahcesehir.edu.tr
Study Locations
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Istanbul, Turkey (Türkiye)
- Recruiting
- Kurtkoy Ozel Egitim ve Rehabilitasyon Merkezi
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Contact:
- Burak Yaşar
- Phone Number: +905050181505
- Email: bynsunal@gmail.com
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Principal Investigator:
- Betul Unal, PhD (C)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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) -
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Motor Imagery Group
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. |
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:
Walking activities:
Bimauel upper extremity activities
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Active Comparator: Action Observation Therapy Group:
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.
|
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:
Walking activities:
Bimauel upper extremity activities
|
|
Active Comparator: Conventional physiotherapy group
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).
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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ABILHAND-Kids
Time Frame: 0th week; 8th week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Quality of Life Inventory (PedsQL)
Time Frame: 0th week; 8th week
|
Quality of life assessed using the Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy Module Child and Parent Reports.
The 35-item questionnaire evaluates daily activities, school activities, movement and balance, pain, fatigue, eating activities, and speech and communication in children with cerebral palsy.
Items are scored on a 5-point Likert scale and transformed to a 0-100 scale.
Higher scores indicate better quality of life.
|
0th week; 8th week
|
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Jebsen-Taylor Hand Function Test
Time Frame: 0th week; 8th week
|
Hand function assessed using the Jebsen-Taylor Hand Function Test (JTHFT), a standardized measure of fine and gross motor hand function during simulated activities of daily living. The test consists of seven subtests, including writing, page turning, lifting small objects, simulated feeding, stacking, and lifting light and heavy objects. Performance is measured as completion time in seconds for each subtest and total test time using a stopwatch. Measurement method: Each task is performed as quickly as possible. Time is measured in seconds with a stopwatch. Each task is recorded separately. Scoring system: Time elapsed for each subtest (in seconds) is used. Total score: sum of subtest times or total time separately for each hand. Lower completion time indicates better hand function. |
0th week; 8th week
|
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The Child and Adolescent Scale of Participation (CASP)
Time Frame: 0th week; 8th week
|
The CASP questionnaire assesses an individual's community participation in home, school, and neighborhood settings.
It consists of 20 questions in total, with 4 sub-sections: Home participation (6 questions), neighborhood and community participation (4 questions), school Participation (5 questions), and home and community activities (5 questions).
Scoring system: 4 = expected for their age (full participation), 3= somewhat limited, very limited, 2=unable, and 1=not applicable.
Total and/or domain scores are calculated, and scores transformed to a standardized 0-100 scale.
Higher scores indicate better levels of participation in daily life activities.
|
0th week; 8th week
|
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Gross Motor Function Measure (GMFM)
Time Frame: 0th week; 8th week
|
Gross motor function assessed using the Gross Motor Function Measure (GMFM-88), a standardized assessment tool for children with cerebral palsy.
The scale consists of 88 items across five domains: lying and rolling, sitting, crawling and kneeling, standing, and walking/running/jumping. Items are scored on a 4-point Likert scale according to the child's level of performance.
Total scores range from 0 to 264, with higher scores indicating better gross motor function.
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0th week; 8th week
|
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Timed Up and Go Test
Time Frame: 0th week; 8th week
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Functional mobility assessed using the Timed Up and Go Test (TUG).
Participants are instructed to stand up from a chair, walk 3 meters, turn around, return to the chair, and sit down.
Completion time is measured in seconds using a stopwatch.
Lower completion times indicate better functional mobility.
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0th week; 8th week
|
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Five Times Sit-to-Stand Test
Time Frame: 0th week; 8th week
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Lower extremity functional strength assessed using the Five Times Sit-to-Stand Test (5xSTS).
Participants are instructed to stand up and sit down five times as quickly as possible from a standard chair without using upper extremity support.
Completion time is measured in seconds using a stopwatch.
Lower completion times indicate better functional performance.
|
0th week; 8th week
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hasan K. Alptekin, Prof. Dr., Bahcesehir university
- Study Director: Pelin Pisirici, Assoc. Prof., Bahcesehir university
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-78097791-020-5100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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