Status:
COMPLETED
Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury
Lead Sponsor:
I.R.C.C.S. Fondazione Santa Lucia
Conditions:
Traumatic Brain Injury
Severe Traumatic Brain Injury
Eligibility:
All Genders
15-65 years
Phase:
NA
Brief Summary
Traumatic brain injury (TBI) is an acquired insult to the brain from an external mechanical force. It is considered a major cause of mortality and of long-term disabilities in young adults, especially...
Eligibility Criteria
Inclusion
- age between 15 and 65 years;
- Glasgow coma scale (GCS) score ≤ 8 (used to objectively describe the severity of impaired consciousness at the time of injury)
- level of cognitive functioning (LCF) ≥7;
- ability to understand verbal commands.
- acclimatization to water.
Exclusion
- Cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination \> 24);
- Severe unilateral spatial neglect (diagnosed with a test battery that included the Letter Cancellation test, Barrage test, Sentence Reading test and the Wundt-Jastrow Area Illusion Test);
- Severe aphasia (diagnosed by means of neuropsychological assessment);
- Presence of other neurological diseases;
- Presence of cutaneous and mycosis infections;
- Presence of open wounds, eczema, skin ulcers, decubitus lesions, severe burns;
- Presence of PEG (Percutaneous endoscopic gastrostomy);
- Presence of tracheostomy;
- Urinary incontinence;
- Presence of otitis
- Presence of orthopedic or cardiac comorbidities that would limit participation in the experimental and conventional training (all of which were clinically evaluated).
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04383405
Start Date
September 1 2019
End Date
May 2 2020
Last Update
May 12 2020
Active Locations (1)
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1
Marco Tramontano
Rome, Italy, 00179