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Идёт набор NCT07612371

Effects of Motor Imagery and Action Observation on Motor Function in Unilateral Cerebral Palsy

Без фазы С лечением Cerebral Palsy (CP)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: motor imagery, Action observation therapy, Conventional physiotherapy group.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy (CP). Базовые параметры: 7 лет — 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое motor imagery
    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.
  • Другое 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: * Single-leg standing balance * Sit and stand up with your arms crossed in f
  • Другое Conventional physiotherapy 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).

Первичные конечные точки

  • ABILHAND-Kids [Срок оценки: 0th week; 8th week]
Вторичные конечные точки (6)
  • Pediatric Quality of Life Inventory (PedsQL) [Срок оценки: 0th week; 8th week]
  • Jebsen-Taylor Hand Function Test [Срок оценки: 0th week; 8th week]
  • The Child and Adolescent Scale of Participation (CASP) [Срок оценки: 0th week; 8th week]
  • Gross Motor Function Measure (GMFM) [Срок оценки: 0th week; 8th week]
  • Timed Up and Go Test [Срок оценки: 0th week; 8th week]
  • Five Times Sit-to-Stand Test [Срок оценки: 0th week; 8th week]

Критерии участия

Критерии включения

  • 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) -

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Kurtkoy Ozel Egitim ve Rehabilitasyon Merkezi — Istanbul

Публикации

  • 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 24237279
  • 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 23886886
  • 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 32982541
  • 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 38512713
  • 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 23232157
  • 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 30123250

Идентификаторы

NCT: NCT07612371 · E-78097791-020-5100

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗