Impact Of Early Cognitive Rehabilitatio… | Clinical Trial

Key information

Conditions

TBI (Traumatic Brain Injury) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University hospital, Cairo, Manial, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

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 .

coma stimulation incorporated with cognition training such as : i. Multimodal Sensory stimulation, including :

Visual
Auditory
Olfactory
Gustatory
Tactile- Administered by rubbing different textures like satin, silk, fur, smooth metal, sandpaper, or cool or warm items over the patient's body surfaces.

ii. Calling out their names, using patient's relatives help for transferring were used for improving the cognition and conscious levels.

Kinesthetic Stimulation

Passive movements
Joint approximation Each movement two times, allowing 1 minute to respond. This will be performed either in bed or in the wheelchair, one extremity at a time.

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.

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

Primary outcomes

Glassgow Coma Scale

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amany Saadallah Hassan Mobarez

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: May 21, 2025
Registry last updated: May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting