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Completed

NCT Number: NCT05521815

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

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).

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Key information

Conditions

Traumatic Brain Injury With Loss of Consciousness

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr el Aini hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Coma arousal therapy

Other

early coma arousal therapy program in addition to selected physical therapy program (positioning, breathing exercise, passive movement of the four limbs).

Selected physiotherapy program

Other

selected physiotherapy program only (positioning, breathing exercise, passive movement of the four limbs).

Primary outcomes

  1. conscious level

    Time frame: One and half year

    is defined as the state of awareness of the self and environment with appropriate arousal or wakefulness. conscious level will be measured using glascow coma scale (GCS), which is a scale used to objectively describe the extent of impaired consciousness in all types of acute medical and trauma patients. The highest possible GCS score is 15, and the lowest is 3. A score of 15 means you're fully awake, responsive and have no problems with thinking ability or memory. Generally, having a score of 8 or fewer means you're in a coma. The lower the score, the deeper the coma is.

  2. Cognition

    Time frame: One and half year

    'cognition' refers to all the processes by which the sensory input is transformed, reduced, elaborated, stored, recovered, and used. It is concerned with these processes even when they operate in the absence of relevant stimulation, as in images and hallucinations. cognition will be measured using Rancho Los Amigos Revised Scale (RLAS-R), its a scale used by both medical and rehabilitation providers to measure and track cognitive recovery after traumatic brain injury. It is a 10-point scale where Level I indicates No response/total assistance and Level X indicates Purposeful, appropriate/ modified independent.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2022
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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