Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury

Study Overview
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Brief Summary
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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).

Official Title
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Aquatic Therapy During Post-acute Intensive Neurorehabilitation in Patients With Severe Traumatic Brain Injury: a Preliminary Randomized Controlled Trial

Conditions
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Traumatic Brain Injury, Severe Traumatic Brain Injury

Intervention / Treatment
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* Other: Aquatic Training
* Other: Conventional Training


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential Preparotory Approach<br> | Other: Aquatic Training<br>* Aquatic Training training consists of a sequential and a preparatory approach aimed at enhancing dynamic postural stability. The exercises follow a specific sequence starting from a kneeling position, proceeding to a sitting position and ending with a supine position. Step exercises preparatory for gait were performed using a step and two floating aids. Gait exercises were performed first with the upper limbs placed on two floating aids and then during a dual motor task (i.e. catching a ball thrown by the therapist). Subjects performed three sessions a week for four weeks and each session lasting 45 minutes. The training was carried out by a physiotherapist who had at least 5 years of experience in aquatic neurorehabilitation.<br>|
| Active Comparator: Conventional<br> | Other: Conventional Training<br>* Conventional land-based therapy consists of customized exercises focused on static and dynamic postural stability improvement. The exercises included the active-assisted mobilization, the muscle stretching the postural transition, the balance and the gait training. The control approach was carried out three times a week for four weeks and each session lasted 45 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Berg Balance Scale (BBS) at 1month | Change of Berg Balance Scale (BBS) from baseline at 1 month. BBS values ranging from 0 to 56, where 0 means the lowest level of function and 56 the highest | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinetti Balance and Gait Scale (TBG) | Change of Tinetti Balance and Gait Scale (TBG) from baseline at 4 weeks of training and at 4 weeks after the end of the training. TBG values ranging from 0 to 28, where 0 means the worse outcome and 28 the best one. | baseline and after 4 weeks of training | 
| Modified Barthel Index (MBI) | Change of Modified Barthel Index (MBI) from baseline at 4 weeks of training and at 4 weeks after the end of the training. MBI values ranging from 0 to 105, where 0 means the worse outcome and 105 the best one. | baseline and after 4 weeks of training | 
| Modified Ashworth Scale (MAS) | Change of Modified Ashworth Scale (MAS) from baseline at 4 weeks of the training and at 4 weeks after the end of the training. MAS values ranging from 0 to 5, where 0 means the best outcome and 5 the worse one. | baseline and after 4 weeks of training | 
| Change in quality of life assessed by the proxy version of the Quality of Life after Brain Injury (Proxy-QOLIBRI) | Change of proxy version of the Quality of Life after Brain Injury (Proxy-QOLIBRI) from baseline at 4 weeks of training and at 4 weeks after the end of the training. (Proxy-QOLIBRI) values ranging from 0 to 100, where 0 means the worse outcome and 100 the best one. | baseline and after 4 weeks of training | 
| Disability Rating Scale (DRS) | Measure of function after TBI intended to measure function from coma to community. Minimum score= 0; Maximum score= 29 (High scores are indicative of greater degree of disability). | baseline and after 4 weeks of training |