Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury

NCT ID: NCT04383405

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-05-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sequential Preparotory Approach

Group Type: EXPERIMENTAL

Aquatic Training

Intervention Type: 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.

Conventional

Group Type: ACTIVE_COMPARATOR

Conventional Training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Marco Tramontano

head of rehabilitation Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marco Tramontano

Rome, , Italy

Countries

Italy

Other Identifiers

CE/PROG775/2019SPA

Identifier Type: -

Identifier Source: org_study_id