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

NCT ID: NCT06981897

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-07-01

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 .

Conditions

TBI (Traumatic Brain Injury)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

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

Group Type: EXPERIMENTAL

early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise).

Intervention Type: 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 .

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.

selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program

Intervention Type: 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

Intervention Type: 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

Control group

Seventeen Patients in control group will receive selected physiotherapy program only Chest care exercise, passive movement of the four limbs.

Group Type: EXPERIMENTAL

selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program

Intervention Type: 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

Intervention Type: 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

Interventions

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, 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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

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. -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amany Saadallah Hassan Mobarez

OTHER

Sponsor Role: lead

Responsible Party

Amany Saadallah Hassan Mobarez

Senior physiotherapist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eman S. M. Fayez, Prof.

Role: STUDY_DIRECTOR

Professor of Physical Therapy , Cairo University

Ahmad A.S. El-Fiki, Prof.

Role: STUDY_DIRECTOR

Professor of Neurosurgery , Cairo University

Maged A. Gomaa, Ass.Prof.

Role: STUDY_DIRECTOR

Associate professor of psychiatry, Cairo University

Locations

Cairo University hospital

Cairo, Manial, Egypt

Kasr Al-Ainy Emergency Hospital185

Cairo, , Egypt

Cairo University hospital

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

https://www.biomedcentral.com/

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.

Other Identifiers

TBI

Identifier Type: -

Identifier Source: org_study_id