Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury

NCT04383405 | Completed

• 1 other identifier: CE/PROG775/2019SPA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury; Severe Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Tinetti Balance and Gait Scale (TBG)

  baseline and after 4 weeks of training

• Modified Barthel Index (MBI)

  baseline and after 4 weeks of training

• Modified Ashworth Scale (MAS)

  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)

  baseline and after 4 weeks of training

• Disability Rating Scale (DRS)

  baseline and after 4 weeks of training

Study Arms (2)

Sequential Preparotory Approach

EXPERIMENTAL

Other: Aquatic Training

Conventional

ACTIVE COMPARATOR

Other: Conventional Training

Interventions

Aquatic Training OTHER

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.

Sequential Preparotory Approach

Conventional Training OTHER

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.

Conventional

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Marco Tramontano

Rome, 00179, Italy

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of rehabilitation Services

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: September 1, 2019
• Primary Completion: April 19, 2020
• Study Completion: May 2, 2020
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

IT (1)