Clinical trial NCT04383405: Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury
Official title: Aquatic Therapy During Post-acute Intensive Neurorehabilitation in Patients With Severe Traumatic Brain Injury: a Preliminary Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Severe Traumatic Brain Injury
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 considering high-income countries.

The TBI can cause a wide range of temporary and/or permanent brain's dysfunctions that can involve physical, cognitive, behavioural and emotional functioning limiting everyday life and social activities and leading to a lowers quality of life.

a sequential preparatory approach (SPA), performed in aquatic environment, based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex) could be an effective complementary training during post-acute intensive rehabilitation in patients with severe traumatic brain injury (sTBI).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
measure: Change in Berg Balance Scale (BBS) at 1month
timeFrame: 1 month
Secondary outcomes:
measure: Tinetti Balance and Gait Scale (TBG)
timeFrame: baseline and after 4 weeks of training
measure: Modified Barthel Index (MBI)
timeFrame: baseline and after 4 weeks of training
measure: Modified Ashworth Scale (MAS)
timeFrame: baseline and after 4 weeks of training
measure: Change in quality of life assessed by the proxy version of the Quality of Life after Brain Injury (Proxy-QOLIBRI)
timeFrame: baseline and after 4 weeks of training
measure: Disability Rating Scale (DRS)
timeFrame: baseline and after 4 weeks of training
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Marco Tramontano
Study officials:
References: