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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06981897
Enrollment
34
Registered
2025-05-21
Start date
2023-12-01
Completion date
2025-07-01
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TBI (Traumatic Brain Injury)

Keywords

COGNITION / TBI/

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 .

Interventions

BEHAVIORALearly 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, 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. 2. Kinesthetic Stimulation 1. Passive movements 2. 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.

BEHAVIORALselected 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.

BEHAVIORALControl 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

Sponsors

Amany Saadallah Hassan Mobarez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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. -

Design outcomes

Primary

MeasureTime frameDescription
Glassgow Coma Scaleevaluation post every week at first two weeks of treatment at ICU after injurybeing 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 scaleevaluation post every week at first two weeks of treatment at ICU after injuryevauating 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 Measureevaluation post every week at first two weeks of treatment at ICU after injuryassess 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026