RecruitingNot ApplicableNCT06920784

Prismatic Adaptation in Cognitive Rehabilitation

Prismatic Adaptation for Cognitive Rehabiliation in Traumatic Brain Injury Patients


Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

50 participants

Start Date

Nov 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims to evaluate the effects of prismatic adaptation and then of a novel rehabilitation protocol that combines PA and Serious Games on cognitive and behavioural deficits in patients with traumatic brain injury , compared to a rehabilitation training without prismatic adaptation. Moreover, this study aims to assess the impact of this rehabilitation protocol on functional cognitive outcomes. Hypothesis Hypothesis 1 (H1): It is postulated that the utilization of Prismatic Adaptation Treatment (PAT) has a positive impact on the enhancement of cognitive outcome among patients suffering from TBI Hypothesis 2 (H2): It is hypothesized that there will be discernible alterations in resting-state Electroencephalography (EEG) patterns between the initial assessment point (T0) and the subsequent measurement during the course of treatment (T1) in individuals diagnosed with TBI Assessment times of outcome measures will be conducted before the experimental treatment (T0) and after the 10 rehabilitation sessions (T1). Patients will be randomized into two groups: 1. Experimental group: Patients receiving treatment with prismatic lenses and serious games lasting 10 days over a span of 2 weeks, for 40 minutes each session. 2. Control group: patients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session. Both groups will receive also the standard cognitive rehabilitation for the detected deficits, using paper and pen materials. Each rehabiliation session will last aproximately 1 hour for 5 days a week for 2 weeks.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age >18 years
  • Traumatic brain injury (TBI)
  • Rancho Level of Cognitive Functioning (LCF) for TBI patients > 4
  • Admission within 90 days from the onset

Exclusion Criteria11

  • Unilateral Spatial Neglect
  • Aphasia
  • Severe vigilance deficits
  • Severe verbal comprehension deficits
  • Motor deficits of both hands
  • Previous neurological stroke
  • Previous neurological disease
  • Previous psychiatric disease
  • Use of alcohol or drugs
  • Severe visual deficits
  • Premorbid dementia

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEPRISMATIC ADAPTATION

The experimental treatment includes a session of prismatic adaptation, in which patients, wearing priasmatic lenses, performs pointing exercises using an 11'' tablet. The visual target is represented by a black squares randomly presented in one of three spatial positions of the tablet's screen (in the centre of the screen or at 21° to the right or to the left space). Taking into account the type of lesion resulting from traumatic brain injury, the prismatic deviation induced by the lenses will be changed alternately from right to left. Then patients will wear rightward prism lenses for 5 days and leftward prism lenses for other 5 days. The prismatic deviation will be randomized. Following these prismatic adaptation, lasting 10 minutes, cognitive training with serious games will be performed, for the remaining 30 minutes.

DEVICESerious games

patients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session.


Locations(5)

Istituti Clinici Scientifici Maugeri IRCCS

Bari, Italy

Istituti Clinici Scientifici Maugeri IRCCS

Bari, Italy

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, Italy

Istituti Clinici Scientifici Maugeri IRCCS

Sciacca, Italy

Istituti Clinici Scientifici Maugeri IRCCS

Telese Terme, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06920784


Related Trials