Actively Recruiting
Prismatic Adaptation in Cognitive Rehabilitation
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-03-25
50
Participants Needed
5
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prismatic Adaptation in Cognitive Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Diagnosis of traumatic brain injury (TBI)
- Rancho Level of Cognitive Functioning for TBI patients greater than 4
- Admission to rehabilitation within 90 days from injury onset
You will not qualify if you...
- Presence of unilateral spatial neglect
- Aphasia
- Severe vigilance deficits
- Severe verbal comprehension deficits
- Motor deficits affecting both hands
- Previous neurological stroke
- History of neurological disease
- History of psychiatric disease
- Use of alcohol or drugs
- Severe visual deficits
- Premorbid dementia
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Istituti Clinici Scientifici Maugeri IRCCS
Bari, Italy, 70124
Actively Recruiting
2
Istituti Clinici Scientifici Maugeri IRCCS
Bari, Italy, 70124
Actively Recruiting
3
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, Italy, 27100
Actively Recruiting
4
Istituti Clinici Scientifici Maugeri IRCCS
Sciacca, Italy, 92019
Actively Recruiting
5
Istituti Clinici Scientifici Maugeri IRCCS
Telese Terme, Italy, 82037
Actively Recruiting
Research Team
S
Simona Spaccavento, Psychologist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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