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Enrolling by invitation Not applicable

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

NCT06981897 · tracked via the Priya Life Science Egypt tracker
Sponsor
Amany Saadallah Hassan Mobarez
Phase
Not applicable
Started
2023-12-01
Last updated
2025-05-21

Condition(s) studied

TBI (Traumatic Brain Injury)

Investigational drug(s) / intervention(s)

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 programControl group

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.

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.

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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. -

Primary outcome measure(s)

  • Glassgow Coma Scale — 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 — 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 — 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.

Trial sites (3)

FacilityCityRegionStatus
Cairo University hospital Cairo Manial
Kasr Al-Ainy Emergency Hospital185 Cairo Egypt
Cairo University hospital Cairo Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06981897 on ClinicalTrials.gov ↗ ← All trials in Egypt