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

NCT ID: NCT05521815

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2023-11-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Traumatic Brain Injury With Loss of Consciousness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Study group

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

Group Type ACTIVE_COMPARATOR

Coma arousal therapy

Intervention Type OTHER

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

Control group

This group will receive only traditional treatment program

Group Type PLACEBO_COMPARATOR

Selected physiotherapy program

Intervention Type OTHER

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

Interventions

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Coma arousal therapy

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

Intervention Type OTHER

Selected physiotherapy program

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Samir Mohamed Amin Sayed

Senior Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr el Aini hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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54531

Identifier Type: -

Identifier Source: org_study_id