Impact Of Early Cognitive Rehabilitation On Functional Outcomes Following Moderate Traumatic Brain Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 34
- Locations
- 3
- Primary Endpoint
- Glassgow Coma Scale
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Both Genders.
- •Moderate traumatic brain injury patients will be included with GCS score 9-
- •Patients' age 18 years old and more .
- •All patients must be medically stable post trauma.
Exclusion Criteria
- •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. -
Arms & Interventions
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
Intervention: early cognitive therapy program in addition to selected physical therapy program (positioning, chest care exercise). (Behavioral)
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
Intervention: selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program (Behavioral)
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
Intervention: Control group (Behavioral)
Control group
Seventeen Patients in control group will receive selected physiotherapy program only Chest care exercise, passive movement of the four limbs.
Intervention: selected physical therapy program (Chest care exercise, passive movement of the four limbs) in addition to early cognitive therapy program (Behavioral)
Control group
Seventeen Patients in control group will receive selected physiotherapy program only Chest care exercise, passive movement of the four limbs.
Intervention: Control group (Behavioral)
Outcomes
Primary Outcomes
Glassgow Coma Scale
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Amany Saadallah Hassan Mobarez
Senior physiotherapist
Cairo University