Clinical trial NCT06981897: Impact Of Early Cognitive Rehabilitation On Functional Outcomes Following Moderate Traumatic Brain Injury
Official title: Impact Of Early Cognitive Rehabilitation On Functional Outcomes Following Moderate Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Keywords: COGNITION / TBI/
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 .

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Glassgow Coma Scale
timeFrame: evaluation post every week at first two weeks of treatment at ICU after injury
measure: Rancho Los amigos scale
timeFrame: evaluation post every week at first two weeks of treatment at ICU after injury
measure: Functional Independence Measure
timeFrame: evaluation post every week at first two weeks of treatment at ICU after injury
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University hospital
state: Manial
city: Cairo
country: Egypt
facility: Kasr Al-Ainy Emergency Hospital185
city: Cairo
country: Egypt
facility: Cairo University hospital
Study officials:
affiliation: Professor of Physical Therapy , Cairo University
name: Eman S. M. Fayez, Prof.
role: STUDY_DIRECTOR
affiliation: Professor of Neurosurgery , Cairo University
name: Ahmad A.S. El-Fiki, Prof.
role: STUDY_DIRECTOR
affiliation: Associate professor of psychiatry, Cairo University
name: Maged A. Gomaa, Ass.Prof.
role: STUDY_DIRECTOR
References: