Impact Of Early Cognitive Rehabilitation On Functional Outcomes Following Moderate Traumatic Brain Injury

Обзор

Purpose of the study: This study aims to detect the impact of early cognitive rehabilitation on functional outcomes with patients following moderate traumatic brain injury.

Подробное описание

Intensive care unit (ICU) hospitalization saves lives but often costs ICU survivors, who often experience cognitive impairment and physical and functional disabilities. Early physical rehabilitation improves chances of regaining pre-hospital functional status, but early cognitive rehabilitation for these patients remains unexplored Traumatic brain injury occurs from violent blows or objects, causing physical and psychological effects. Signs may appear immediately or days later, affecting the brain's function and functioning . Traumatic Brain Injury (TBI) impacts health and quality of life, with unpredictable prognosis. Exercise is crucial for neuroplasticity and brain rewiring.The Glasgow Coma Scale, published in 1974, measures impaired consciousness in acute medical and trauma patients using eye-opening, motor, and verbal responses. It provides a clear, communicable picture of a patient's state.

The Rancho Los Amigos Scale (RLAS) is a medical assessment tool for individuals recovering from closed head injuries, including traumatic brain injuries. It evaluates cognitive and behavioral presentations as they emerge from coma, comparing patients' state of consciousness and reliance on assistance .

The Functional Independence Measure (FIM) is an 18-item assessment tool for evaluating patients' functional status in rehabilitation after stroke, traumatic brain injury, spinal cord injury, or cancer. It evaluates self-care, continence, mobility, transfers, communication, and cognition, with each item rated 1-7 .

Вмешательства

• Поведенческое early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise).
  A.Positioning for head injury patients B.Chest clearance intervention C.Procedure for cognitive therapy All these exercises are given to patients even when they are on ventilator support of around 20-30 minutes six days /week . 1. coma stimulation incorporated with cognition training such as : i. Multimodal Sensory stimulation, including : 1. Visual 2. Auditory 3. Olfactory 4. Gustatory 5. Tactile- Administered by rubbing different textures like satin, silk, fur, smooth metal,
• Поведенческое selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program
  The patient was placed in a comfortable position with a head-up position Passive range of movement for all four limbs \& positioning for head injury patients,. Joint approximation and Chest clearance intervention and Procedure for cognitive therapy Multimodal Sensory stimulation, including : Visual Auditory- Olfactory-. Gustatory- Tactile- Calling out their names, using patients relative help for transferring were used for improving the cognition and conscious levels.
• Поведенческое Control group
  The patient was placed in a comfortable position with a head-up position , Passive range of movement for all four limbs and positioning for head injury patients,. Joint approximation and Chest clearance intervention

Первичные конечные точки

• Glassgow Coma Scale [Срок оценки: evaluation post every week at first two weeks of treatment at ICU after injury]
• Rancho Los amigos scale [Срок оценки: evaluation post every week at first two weeks of treatment at ICU after injury]
• Functional Independence Measure [Срок оценки: evaluation post every week at first two weeks of treatment at ICU after injury]

Критерии участия

Критерии включения

• Both Genders.
• Moderate traumatic brain injury patients will be included with GCS score 9-12.
• Patients' age 18 years old and more .
• All patients must be medically stable post trauma.

Критерии исключения

• children under 18 years old .
• Previous cerebral infarction and intracranial space-occupying lesions.
• Patients with cancer and major underlying illnesses.
• Patients with diffuse axonal damage.
• Incomplete clinical and imaging data
• Patient with other neurological deficits or orthopedic abnormalities that causing disability.
• Patients with serious psychiatric pathology or mentally. -

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 3 центра

• Cairo University hospital — Cairo
• Kasr Al-Ainy Emergency Hospital185 — Cairo
• Cairo University hospital — Cairo

Идентификаторы

NCT: NCT06981897 · TBI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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