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

NCT06981897 | Enrolling By Invitation DMC

• 1 other identifier: TBI
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

COGNITION / TBI/

Outcome Measures

Primary Outcomes (3)

• 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.

  evaluation post every week at first two weeks of treatment at ICU after injury

Study Arms (2)

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

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.

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

Interventions

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 . 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.

study group

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; study group

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

Control group; study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Amany Saadallah Hassan Mobarez: lead

Study Sites (3)

Cairo University hospital

Cairo, Manial, 11562, Egypt

Location

Kasr Al-Ainy Emergency Hospital185

Cairo, 11562, Egypt

Location

Cairo University hospital

Cairo, Egypt

Location

Related Links

• 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.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Patient Positioning; Control Groups

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior physiotherapist

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 21, 2025
• Study Start: December 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)