- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07631390
Impact of Task-Specific Electrical Stimulation on Upper Limb Functional Motor Skills in Children With Spastic Quadriplegia
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Cerebral palsy (CP) encompasses a clinically diverse group of permanent but non-progressive disorders of posture and movement caused by disturbances in the developing brain (Rosenbaum et al., 2007). Spastic quadriplegia, also known as spastic tetraplegia, is a major subtype of spastic CP, characterized by significant impairment in motor function involving all four limbs and the trunk. Unlike spastic hemiplegia, which affects one side of the body, or spastic diplegia, which predominantly involves the lower limbs, spastic quadriplegia is defined by the bilateral and symmetric involvement of upper and lower extremities-often with the upper limbs being as severely, or more severely, affected than the lower extremities (Beckung et al., 2007; Palisano et al., 2009). Spastic quadriplegia is considered the most severe form of CP. Epidemiological data indicate that this subtype accounts for approximately 20-30% of all children with CP, with some variability by region and study population (Beckung et al., 2007). The condition affects both males and females and is not limited to any particular ethnic or socioeconomic group. 2. Etiology and Pathophysiology The etiology of spastic quadriplegia is multifactorial, primarily involving prenatal, perinatal, or early postnatal injury to the developing brain. The most common causes include:
- Prenatal factors: Intrauterine infections, genetic abnormalities, placental insufficiency, and exposure to toxins.
- Perinatal factors: Birth asphyxia, prematurity, intracranial hemorrhage, and periventricular leukomalacia (PVL).
- Postnatal factors: Neonatal stroke, traumatic brain injury, severe infections (e.g., meningitis, encephalitis). Brain imaging in children with spastic quadriplegia frequently reveals extensive lesions, often affecting both cortical and subcortical structures, periventricular white matter, and the basal ganglia. Lesions are typically bilateral and may include multicystic encephalomalacia or severe PVL (Rosenbaum et al., 2007; Novak et al., 2013). The widespread nature of 24 the injury explains the symmetric involvement of all limbs and the profound motor deficits observed in this population. The pathophysiology underlying spasticity includes disruption of descending inhibitory pathways, particularly those modulating the stretch reflex, resulting in increased muscle tone, hyperreflexia, and reduced reciprocal inhibition (Damiano, 2006). 3. Clinical Features The hallmark of spastic quadriplegia is the presence of bilateral spasticity affecting both upper and lower limbs, with notable involvement of the trunk and orofacial muscles in many cases. Clinical manifestations include:
- Severe motor impairment: Marked spasticity, muscle weakness, and decreased selective voluntary motor control in all extremities (Beckung et al., 2007).
- Joint contractures and deformities: Chronic spasticity often leads to fixed contractures, particularly at the shoulders, elbows, wrists, hips, knees, and ankles.
- Postural instability: Poor trunk and head control, often resulting in scoliosis, pelvic obliquity, and difficulties with sitting balance.
- Abnormal movement patterns: Persistence of primitive reflexes, synergistic patterns, and lack of dissociated movements.
- Oromotor and bulbar involvement: Dysarthria, drooling, and feeding difficulties are common due to spasticity of facial and bulbar muscles.
- Associated impairments: Cognitive impairment, epilepsy, sensory deficits (visual and auditory), and behavioral problems occur at higher rates in this population (Palisano et al., 2009; Novak et al., 2013). 4.Upper Limb Function in Spastic Quadriplegia Impairment of upper limb function is a cardinal feature and a primary determinant of disability in spastic quadriplegia. Key features include:
- Spasticity and weakness: Typically most pronounced in the flexor muscles of the upper limbs (shoulder adductors, elbow flexors, wrist and finger flexors).
- Impaired selective motor control: Difficulty isolating joint movements leads to mass grasp and release patterns, limiting dexterity and functional hand use (DeMatteo et al., 1992).
- Contractures: Especially common at the elbows and wrists, further limiting range of motion and functional reach.
- Poor postural control: Inadequate trunk stability compromises the ability to use the arms for support or manipulation.
- Functional impact: Profound limitations in reaching, grasping, releasing, weight-bearing, and manipulating objects undermine the ability to perform self-care, use assistive devices, participate in play and education, and interact socially (Palisano et al., 2009). Task-Specific Electrical Stimulation (TASES) Task-specific electrical stimulation (TASES) represents a significant evolution in the application of neurostimulation in neurorehabilitation. Unlike traditional NMES or FES, which may be applied passively or in a cyclic fashion, TASES is explicitly synchronized with active, goal directed motor tasks to maximize the interplay between voluntary effort and afferent feedback (Gordon et al., 2013; Daly et al., 2006). This approach is rooted in the principles of motor learning and neuroplasticity, which posit that the repetition of meaningful, contextually relevant tasks fosters more robust and lasting changes in the central nervous system than passive exercise alone (Kleim & Jones, 2008; Nudo, 2006). Principles and Mechanisms The primary premise of TASES is that coupling electrical stimulation with volitional, task-driven movement enhances motor output by:
- Increasing sensory feedback during task execution, thereby strengthening sensorimotor integration
- Facilitating the recruitment of motor units that might otherwise be difficult to activate voluntarily, especially in paretic or spastic muscles
- Reinforcing the temporal and spatial patterns of muscle activation required for functional tasks 40 By delivering stimulation at key points during a task (for example, during the weight-bearing phase of a push-up or during wrist extension as the hand contacts a support surface), TASES can help children with severe motor impairments more effectively engage muscles critical for upper limb function (Gordon et al., 2013; Daly et al., 2006). Mechanisms Underlying Functional Improvements Understanding the mechanisms by which electrical stimulation, and specifically task-specific electrical stimulation (TASES), improves upper limb function in children with spastic quadriplegia is essential for optimizing therapy and advancing clinical practice. The effects of ES are multifaceted, involving changes at the muscular, neural, and behavioral levels.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Egypt
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Alexandria, Egypt, Египет, 21515
- Aalaa Ahmed Farrag
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Their age will be ranged from 4 to 7 years.
- Their grade of spasticity will be from 1+ to 2 according to Modified Ashworth scale
- They will be on Level III and IV according to Gross Motor Functional Classification System (GMFCS).
- Parents/legals representatives consenting to their child's participation
- Diagnosed with Spastic Quadriplegic cerebral palsy
Exclusion Criteria:
- Previous neurological or orthopedic surgery in the upperextremities.
- Fixed deformity in the joints of upper limb. 3- Severe hearing and visual defect.
4-Irregular attendance at assessments or therapy sessions
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Study group
Task-specific electrical stimulation, was delivered using the NMES (Neuromuscular Electrical Stimulation) mode on the Chattanooga ContinuumTM Portable two channel electrical stimulator. • This device is commonly used for muscle re-education, strengthening and functional rehabilitation. Every kid received three sessions per week for two months; each session lasted one hour, half an hour was for the designed physiotherapy program (as in the control group), and last 20 minutes was for the TASES application during the weight bearing exercises including push up exercise, prone on hands exercise, quadruped with weight shifting, in addition to transition activities as side sitting to quadruped exercise. |
В программе использовалась комбинация упражнений с открытой и закрытой цепью.
Упражнения для облегчения переходов в качестве лежа на спине, чтобы сидеть с подшипником с ручным весом, стороной, лежащей в стороне, сбоку, сидящих в четвероногих упражнениях, подшипниках, склонных к рукам на клине, четырехпенпированных с переплетением веса и ускорением упражнений в течение одного часа.
The Chattanooga Continuum™ (fig.2) is a portable 2 channel stimulator used by therapists in clinics and patients at home to provide electrical stimulation treatments in pain management (TENS) and neuromuscular stimulation (NMES).
By combining TENS with NMES, users can simultaneously help manage pain and enhance exercise,3 thereby shortcutting the traditional muscle recovery cycle.
Factor in a choice of program options including customizable waveforms,and you have a highly versatile and user-friendly rehabilitation tool that can help deliver optimal therapeutic outcomes.
The Continuum Kit includes a transportation pouch and hand switch.
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Активный компаратор: Control group
Every kid received three sessions per week for two months; each session lasted one hour of designed physiotherapy program which included upper limb weight bearing exercises
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В программе использовалась комбинация упражнений с открытой и закрытой цепью.
Упражнения для облегчения переходов в качестве лежа на спине, чтобы сидеть с подшипником с ручным весом, стороной, лежащей в стороне, сбоку, сидящих в четвероногих упражнениях, подшипниках, склонных к рукам на клине, четырехпенпированных с переплетением веса и ускорением упражнений в течение одного часа.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Improved upper limb functional motor skills
Временное ограничение: 2 months after treatment
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The Quality of Upper Extremity Skills Test (QUEST) is used by assessment of the weight bearing domain
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2 months after treatment
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KFSIRB200-1060
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .