Impact Of Early Cognitive Rehabilitation On Functional Outcomes Following Moderate Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- Glassgow Coma Scale
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both Genders.
- •Moderate traumatic brain injury patients will be included with GCS score 9-
- •Patients' age 18 years old and more .
- •All patients must be medically stable post trauma.
排除标准
- •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. -
研究组 & 干预措施
study group
Seventeen Patients in study group will receive selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program
干预措施: early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise). (Behavioral)
study group
Seventeen Patients in study group will receive selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program
干预措施: selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program (Behavioral)
study group
Seventeen Patients in study group will receive selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program
干预措施: Control group (Behavioral)
Control group
Seventeen Patients in control group will receive selected physiotherapy program only Chest care exercise, passive movement of the four limbs.
干预措施: selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program (Behavioral)
Control group
Seventeen Patients in control group will receive selected physiotherapy program only Chest care exercise, passive movement of the four limbs.
干预措施: Control group (Behavioral)
结局指标
主要结局
Glassgow Coma Scale
时间窗: evaluation post every week at first two weeks of treatment at ICU after injury
being aware of and responsive to one's surroundings a person's awareness or perception of something wchich evaluated by glassgow coma scale .No eye opening / 1 No eye opening Eye opening to pain / 2 Eye opening to pain Eye opening to sound / 3 Eye opening to sound Eyes open spontaneously / 4 Eyes open spontaneously Best verbal response None / 1 None Moans in response to pain / 2 Incomprehensible sounds Cries in response to pain / 3 Incomprehensible words Irritable/cries / 4 Confused Coos and babbles / 5 Orientated - appropriate Best motor response No motor response / 1 No motor response. Abnormal extension to pain / 2 Abnormal extension to pain Abnormal flexion to pain / 3 Abnormal flexion to pain Withdrawal to pain / 4 Withdrawal to pain Withdraws to touch / 5 Localises to pain Moves spontaneously and purposefully / 6 Obeys commands
Rancho Los amigos scale
时间窗: evaluation post every week at first two weeks of treatment at ICU after injury
evauating of conscious intellectual activity such as thinking, reasoning or remembering wchich evaluated by The Rancho Los Amigos Scale (RLAS), Level I No response/total assistance Level II Generalised response/total assistance Level III Localised response/total assistance Level IV Confused and agitated/max assist Level V Confused, inappropriate non-agitated/max assist Level VI Confused, appropriate/ mod assist Level VII Automatic, appropriate/ min assist for ADLs Level VIII Purposeful, appropriate/ stand by assist Level IX Purposeful, appropriate/ stand by assist on request Level X Purposeful, appropriate/ modified independent
Functional Independence Measure
时间窗: evaluation post every week at first two weeks of treatment at ICU after injury
assess and grade the functional status of a person based on the level of assistance he or she requires wchich evaluated by functional Independence Measure (FIM)scored on a 7-point Likert scale, and the score indicates the amount of assistance required to perform each item (1 = total assistance in all areas, 7 = total independence in all areas). The ratings are based on performance rather than capacity and can be acquired by observation, patient interview, telephone interview or medical records. The developers of the FIM recommend that the scoring be derived by consensus with a multi-disciplinary team.
次要结局
未报告次要终点
研究者
Amany Saadallah Hassan Mobarez
Senior physiotherapist
Cairo University