Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury

NCT04383405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-05-12

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • I.R.C.C.S. Fondazione Santa Lucia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-04-19
Completion
2020-05-02

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04383405 on ClinicalTrials.gov