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Aquatic Sequential Preparatory Approach and Severe Traumatic Brain Injury

I

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

Status

Completed

Conditions

Traumatic Brain Injury
Severe Traumatic Brain Injury

Treatments

Other: Aquatic Training
Other: Conventional Training

Study type

Interventional

Funder types

Other

Identifiers

NCT04383405
CE/PROG775/2019SPA

Details and patient eligibility

About

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).

Enrollment

20 patients

Sex

All

Ages

15 to 65 years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Sequential Preparotory Approach
Experimental group
Treatment:
Other: Aquatic Training
Conventional
Active Comparator group
Treatment:
Other: Conventional Training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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