Back to results

Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury, Severe Traumatic Brain Injury

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Aquatic Training

Conventional Training

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Marco Tramontano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sequential Preparotory Approach

Conventional

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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.

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.

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).

Full Information

NCT ID

NCT04383405

First Posted

May 7, 2020

Last Updated

May 7, 2020

Sponsor

I.R.C.C.S. Fondazione Santa Lucia

1. Study Identification

Unique Protocol Identification Number

NCT04383405

Brief Title

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

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

April 19, 2020 (Actual)

Study Completion Date

May 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

I.R.C.C.S. Fondazione Santa Lucia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury, Severe Traumatic Brain Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequential Preparotory Approach

Arm Type

Experimental

Arm Title

Conventional

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Aquatic Training

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Conventional Training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Berg Balance Scale (BBS) at 1month

Description

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

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Tinetti Balance and Gait Scale (TBG)

Description

Time Frame