Effect of Early Coma Arousal Therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury

Cairo University (CU)

Status: Completed

Conditions: Traumatic Brain Injury With Loss of Consciousness

Treatments: Other: Selected physiotherapy program; Other: Coma arousal therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05521815

54531

Details and patient eligibility

About

PURPOSE:

The aim of this study is to investigate the effect of early coma arousal therapy on conscious level and cognitive function in sever traumatic brain injury patients.

BACKGROUND:

Traumatic brain injury (TBI) could be simply defined as an alteration in brain function due to external forces and is considered as one of the leading cause of death and disability worldwide, especially among young adults and the elderly. Current estimates imply that annual incidence of TBI is 50-60 million worldwide, and specifically for Europe and USA, 0.5% of Europeans and 1.1% of Americans are experiencing a TBI each year.

The original scale has since been revised and is known as the Rancho Los Amigos Revised Scale (RLAS-R). One of the limitations of the original eight level scale was that it did not accurately reflect the individuals with higher levels of recovery. Two more levels were added to the initial eight level Ranchos Scale to create a more comprehensive ten level scale named the Rancho Los Amigos Revised Scale (RLAS-R).

Full description

The aim of this study is to examine the early effect of coma arousal therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury. forty two patients will be selected and they will be assigned in to two different group, a study group where will they recieve coma arousal therapy in addition to conventional therapy and a control group where they will recieve only the conventional physical therapy program.

Enrollment: 44 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Both genders.
2. Traumatic brain injury with GCS score 3-12.
3. Age range from 20-50 years old.
4. Must be medically stable post trauma 29

Exclusion criteria

1. Patient with other neurological deficits or orthopedic abnormalities that causing disability.
2. Patients with pre injury psychiatric disorders.
3. Patients with pre injury cognitive disorders.
4. Patients who performed surgery post traumatic brain injury.
5. Patients not taking the same medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups, including a placebo group

Study group

Active Comparator group

Description:

The group that are going to receive the coma arousal therapy program

Treatment:

Other: Coma arousal therapy

Control group

Placebo Comparator group

Description:

This group will receive only traditional treatment program

Treatment:

Other: Selected physiotherapy program