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Enrolling by invitation NCT06981897

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

No phase Interventional TBI (Traumatic Brain Injury)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise)., selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program, Control group.
Who it may be relevant to
Registry conditions: TBI (Traumatic Brain Injury). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 .

Interventions

  • Behavioral 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,
  • Behavioral 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.
  • Behavioral 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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 3 centers
  • Cairo University hospital — Cairo
  • Kasr Al-Ainy Emergency Hospital185 — Cairo
  • Cairo University hospital — Cairo

Identifiers

NCT: NCT06981897 · TBI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗