Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Severe Traumatic Brain Injury; Traumatic Brain Injury
• Interventions: Other: Conventional Training; Other: Aquatic Training

• Registration Number: NCT04383405
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-04-19
• Status Verified: 2020-05
• Study Completion: 2020-05-02
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Last Update Submitted: 2020-05-07
• Study First Posted: 2020-05-12
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional Training	-
Sequential Preparotory Approach	Aquatic Training	-

Primary Outcome Measures

Name	Time	Method
Change in Berg Balance Scale (BBS) at 1month	1 month	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

Secondary Outcome Measures

Name	Time	Method
Modified Barthel Index (MBI)	baseline and after 4 weeks of training	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.
Change in quality of life assessed by the proxy version of the Quality of Life after Brain Injury (Proxy-QOLIBRI)	baseline and after 4 weeks of training	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.
Modified Ashworth Scale (MAS)	baseline and after 4 weeks of training	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.
Tinetti Balance and Gait Scale (TBG)	baseline and after 4 weeks of training	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.
Disability Rating Scale (DRS)	baseline and after 4 weeks of training	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).

Trial Locations

Locations (1)

Marco Tramontano; 🇮🇹 Rome, Italy