Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury

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

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).

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Severe Traumatic Brain Injury
• Intervention / Treatment: Other: Aquatic Training; Other: Conventional Training

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00179
    • Marco Tramontano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional	Other: Conventional Training; 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.
Experimental: Sequential Preparotory Approach	Other: Aquatic Training; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: I.R.C.C.S. Fondazione Santa Lucia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): April 19, 2020
• Study Completion (Actual): May 2, 2020

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: CE/PROG775/2019SPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No