Clinical Trials Directory

Trials / Completed

CompletedNCT04383405

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
I.R.C.C.S. Fondazione Santa Lucia · Academic / Other
Sex
All
Age
15 Years – 65 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
OTHERAquatic TrainingAquatic 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.
OTHERConventional TrainingConventional 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.

Timeline

Start date
2019-09-01
Primary completion
2020-04-19
Completion
2020-05-02
First posted
2020-05-12
Last updated
2020-05-12

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04383405. Inclusion in this directory is not an endorsement.