Prismatic Adaptation for Cognitive Rehabiliation in Traumatic Brain Injury Patients

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

• Traumatic brain injury (TBI)

• Rancho Level of Cognitive Functioning (LCF) for TBI patients \> 4

• Admission within 90 days from the onset

Locations
Other Locations
Italy
Istituti Clinici Scientifici Maugeri IRCCS
RECRUITING
Bari
Istituti Clinici Scientifici Maugeri IRCCS
RECRUITING
Bari
Istituti Clinici Scientifici Maugeri IRCCS
RECRUITING
Pavia
Istituti Clinici Scientifici Maugeri IRCCS
RECRUITING
Sciacca
Istituti Clinici Scientifici Maugeri IRCCS
RECRUITING
Telese Terme
Contact Information
Primary
Simona Spaccavento, Psychologist
simona.spaccavento@icsmaugeri.it
+393332783524
Time Frame
Start Date: 2024-11-07
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 50
Treatments
Experimental: Prismatic adaptation group
Patients receiving treatment with prismatic lenses and serious games lasting 10 days over a span of 2 weeks, for 40 minutes each session. This training will be administered using a class I medical device SaMD (Software as a Medical Device) associated to prisms.
Sham_comparator: Control group
patients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session.
Related Therapeutic Areas
Sponsors
Leads: Istituti Clinici Scientifici Maugeri SpA

This content was sourced from clinicaltrials.gov