TBI (Traumatic Brain Injury)NCT06981897
Impact Of Early Cognitive Rehabilitation On Functional Outcomes Following Moderate Traumatic Brain Injury
A study testing early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise). and selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program in people with TBI (Traumatic Brain Injury), run by Amany Saadallah Hassan Mobarez at 3 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise). and selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Nov 2023to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Children under 18 years old, pregnant women, and those with coagulation malfunction or presently on anticoagulant medication.
- Patients with Diffuse Axonal Injury (DAI) as identified on imaging or clinical features.
- Severe brain edema causing significant midline shift or herniation.
- Extensive intraventricular hemorrhage with poor neurological status.
- Skull fractures associated with severe brain parenchymal damage.
- Patients with persistent coma or Glasgow Coma Scale (GCS) < 9 for more than 7 days post-injury.
- Patients with unstable medical conditions or contraindications to rehabilitation.
- Patients with concomitant Spinal Cord Injury (SCI). -
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Kasr Al-Ainy Emergency Hospital185
Cairo, Cairo Governorate, 11562
Cairo University hospital
Cairo, Manial, 11562
Cairo University hospital
Cairo
About this study
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.
Read the 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)
- Being tested
- 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
- Keywords
- COGNITION / TBI/, cogntive rehabilitation therapy, weaning, mechanical ventilator
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise).Behavioural
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 programBehavioural
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 groupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise).; Behavioral: selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program; Behavioral: Control group |
| Control group | Experimental | Seventeen Patients in control group will receive selected physiotherapy program only Chest care exercise, passive movement of the four limbs. Receives: Behavioral: selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program; Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Glasgow Coma Scale (GCS) Score
Scores range from 3 to 15, with higher scores indicating better level of consciousness.
Measured: Assessed at enrollment and followed until first documented improvement of ≥2 points in GCS (up to 2 weeks); first documented improvement reported.
Rancho Los Amigos Scale
Evaluation of cognitive function including conscious intellectual activities such as thinking, reasoning, and memory. Cognitive recovery was assessed using the Rancho Los Amigos Levels of Cognitive Functioning Scale (RLAS).
The scale ranges from Level I (No response/total assistance) to Level X (Purposeful, appropriate/modified independent).
Higher levels indicate better cognitive functioning and greater independence.
Measured: 2 weeks post-treatment.
Functional Independence Measure Motor Subscale
Functional status was assessed using the motor subscale of the Functional Independence Measure (FIM), a standardized instrument used to evaluate the level of assistance required for activities of daily living.
The motor subscale consists of 13 items, each scored on a 7-point Likert scale ranging from 1 (total assistance) to 7 (complete independence).
The total motor subscale score ranges from 13 to 91, with higher scores indicating greater functional independence and lower scores indicating greater dependence on assistance.
Measured: 2 weeks post-treatment.
Functional Independence Measure Cognition Subscale
Cognitive function was assessed using the cognitive subscale of the Functional Independence Measure (FIM). This subscale evaluates comprehension, expression, social interaction, problem solving, and memory.
The cognitive subscale consists of 5 items, each scored on a 7-point Likert scale ranging from 1 (total assistance) to 7 (complete independence).
The total cognitive subscale score ranges from 5 to 35, with higher scores indicating better cognitive independence and lower scores indicating greater dependence on assistance.
Measured: 2 weeks post-treatment.
Secondary outcomes (1)
Mechanical Ventilation Weaning Time
Duration of mechanical ventilation weaning measured in days.
Measured: Duration from initiation of cognitive rehabilitation therapy until successful weaning from mechanical ventilation (up to 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Nov 2023
- Primary completion14 Nov 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- For this study, a neurosurgeon referred 50 patients with moderate traumatic brain injury. Of these, 16 were excluded: three due to death and thirteen due to ineligibility. Thirty-four patients were divided into two equal groups at random via a closed envelope method.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amany Saadallah Hassan Mobarez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amany Saadallah Hassan Mobarez, Cairo University
- Investigators
- Eman S M Fayez, Prof., Study director, Professor of Physical Therapy , Cairo UniversityAhmad A S El-Fiki, Prof., Study director, Professor of Neurosurgery , Cairo UniversityMaged A Gomaa, Ass.Prof., Study director, Associate professor of psychiatry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981897
- Sponsor's protocol ID
- TBI
- Status last verified
- Oct 2026
- First submitted
- 3 May 2025
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Early Cognitive Rehabilitation On Functional Outcomes Following Moderate Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06981897
- Acronym / sponsor ID
- TBI
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- COGNITION / TBI/, cogntive rehabilitation therapy, weaning, mechanical ventilator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Amany Saadallah Hassan MobarezUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For this study, a neurosurgeon referred 50 patients with moderate traumatic brain injury. Of these, 16 were excluded: three due to death and thirteen due to ineligibility. Thirty-four patients were divided into two equal groups at random via a closed envelope method.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Behavioral: early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise)., Behavioral: selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program, Behavioral: Control groupSeventeen 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 |
| Control group | Experimental | Behavioral: selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program, Behavioral: Control groupSeventeen Patients in control group will receive selected physiotherapy program only Chest care exercise, passive movement of the four limbs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Children under 18 years old, pregnant women, and those with coagulation malfunction or presently on anticoagulant medication.
- Patients with Diffuse Axonal Injury (DAI) as identified on imaging or clinical features.
- Severe brain edema causing significant midline shift or herniation.
- Extensive intraventricular hemorrhage with poor neurological status.
- Skull fractures associated with severe brain parenchymal damage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | study group |
| selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy programThe 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. | Behavioural | Control group, study group |
| Control groupThe 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 | Behavioural | Control group, study group |
Primary outcome
Total Glasgow Coma Scale (GCS) Score
Time frame: Assessed at enrollment and followed until first documented improvement of ≥2 points in GCS (up to 2 weeks); first documented improvement reported.
Scores range from 3 to 15, with higher scores indicating better level of consciousness.
Rancho Los Amigos Scale
Time frame: 2 weeks post-treatment.
Evaluation of cognitive function including conscious intellectual activities such as thinking, reasoning, and memory. Cognitive recovery was assessed using the Rancho Los Amigos Levels of Cognitive Functioning Scale (RLAS). The scale ranges from Level I (No response/total assistance) to Level X (Purposeful, appropriate/modified independent). Higher levels indicate better cognitive functioning and greater independence.
Functional Independence Measure Motor Subscale
Time frame: 2 weeks post-treatment.
Functional status was assessed using the motor subscale of the Functional Independence Measure (FIM), a standardized instrument used to evaluate the level of assistance required for activities of daily living. The motor subscale consists of 13 items, each scored on a 7-point Likert scale ranging from 1 (total assistance) to 7 (complete independence). The total motor subscale score ranges from 13 to 91, with higher scores indicating greater functional independence and lower scores indicating greater dependence on assistance.
Functional Independence Measure Cognition Subscale
Time frame: 2 weeks post-treatment.
Cognitive function was assessed using the cognitive subscale of the Functional Independence Measure (FIM). This subscale evaluates comprehension, expression, social interaction, problem solving, and memory. The cognitive subscale consists of 5 items, each scored on a 7-point Likert scale ranging from 1 (total assistance) to 7 (complete independence). The total cognitive subscale score ranges from 5 to 35, with higher scores indicating better cognitive independence and lower scores indicating greater dependence on assistance.
1 secondary outcome
Mechanical Ventilation Weaning Time
Time frame: Duration from initiation of cognitive rehabilitation therapy until successful weaning from mechanical ventilation (up to 2 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman S M Fayez, Prof. study director
Professor of Physical Therapy , Cairo University
Ahmad A S El-Fiki, Prof. study director
Professor of Neurosurgery , Cairo University
Maged A Gomaa, Ass.Prof. study director
Associate professor of psychiatry, Cairo University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise). and selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program in people with TBI (Traumatic Brain Injury), run by Amany Saadallah Hassan Mobarez at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Glasgow Coma Scale (GCS) Score (time frame: Assessed at enrollment and followed until first documented improvement of ≥2 points in GCS (up to 2 weeks); first documented improvement reported.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.