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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | 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 |
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| Control group | Experimental | Seventeen Patients in control group will receive selected physiotherapy program only Chest care exercise, passive movement of the four limbs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise). | Behavioral | 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 .
|
| Measure | Description | Time Frame |
|---|---|---|
| Glassgow Coma Scale | 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 | evaluation post every week at first two weeks of treatment at ICU after injury |
| Rancho Los amigos scale | 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 | evaluation post every week at first two weeks of treatment at ICU after injury |
| Functional Independence Measure | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eman S. M. Fayez, Prof. | Professor of Physical Therapy , Cairo University | Study Director |
| Ahmad A.S. El-Fiki, Prof. | Professor of Neurosurgery , Cairo University | Study Director |
| Maged A. Gomaa, Ass.Prof. | Associate professor of psychiatry, Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University hospital | Cairo | Manial | 11562 | Egypt | ||
| Kasr Al-Ainy Emergency Hospital185 |
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| Label | URL |
|---|---|
| a systematic review following the PRISMA protocol primarily to identify publications that assessed any links between mechanical ventilation (MV) and either cognitive impairment or brain insult, independent of underlying medical conditions. | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 14, 2025 | |
| Reset | Dec 1, 2025 | |
| Release | Dec 2, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 1, 2023 |
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|
| selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program | Behavioral | 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. |
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| Control group | Behavioral | 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 |
|
| evaluation post every week at first two weeks of treatment at ICU after injury |
| Cairo |
| 11562 |
| Egypt |
| Cairo University hospital | Cairo | Egypt |
| Reset | Dec 17, 2025 |
| Release | Dec 22, 2025 |
| Reset | Jan 13, 2026 |
| Release | Jan 16, 2026 |
| Reset | Feb 2, 2026 |
| Release | Feb 17, 2026 |
| Reset | Mar 9, 2026 |
| Release | Mar 10, 2026 |
| Reset | Mar 27, 2026 |
| Release | Mar 27, 2026 |
| Reset | Apr 15, 2026 |
| May 16, 2025 |
| Prot_SAP_ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 14, 2025 | Dec 1, 2025 | |||
| Dec 2, 2025 | Dec 17, 2025 | |||
| Dec 22, 2025 | Jan 13, 2026 | |||
| Jan 16, 2026 | Feb 2, 2026 | |||
| Feb 17, 2026 | Mar 9, 2026 | |||
| Mar 10, 2026 | Mar 27, 2026 | |||
| Mar 27, 2026 | Apr 15, 2026 |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D056888 | Patient Positioning |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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