Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
48 participants
OBSERVATIONAL
2016-10-18
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Smart Autonomous Neuro-Rehabilitation System
NCT02816008
Oral Health for Healthy Cognitive Aging
NCT02986386
Effects of a Daily Cognition Training in Older Adults Without Cognitive Impairment
NCT05688163
Caregiver Training: Evidence of Its Effectiveness for Cognitive and Functional Improvement in Older Adults
NCT04490070
DRIVing Simulator and People With NeuroCognitive Disorders
NCT06320639
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After conducting a literature review of the subject we found that this would be the first protocol developed to identify all these components in the same study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acquired Brain Injury group with anosognosia
People with presence of an acquired brain damage and cognitive deficits relative to executive functions and memory. To determine the presence of anosognosia, patients must present an overestimation value of their capacities greater than 5 (\>5) in the discrepancy index on the Patient Competency Rating Scale (PCRS) (Prigatano et al., 1998).
Cognitive-functional evaluation
The participants will be evaluated with a set of tools within the context of meaningful ADL.
Acquired Brain Injury group without anosognosia
People with presence of an acquired brain damage and cognitive deficits relative to executive functions and memory. These patients must present a score of \< 5 on the PCRS Scale.
Cognitive-functional evaluation
The participants will be evaluated with a set of tools within the context of meaningful ADL.
Control group
Healthy participants matched in age, gender and educational level with the others two groups.
Cognitive-functional evaluation
The participants will be evaluated with a set of tools within the context of meaningful ADL.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive-functional evaluation
The participants will be evaluated with a set of tools within the context of meaningful ADL.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Cognitive deficits relative to executive functions and/or memory evaluated by the team of professionals who recruit participants in the hospital.
Exclusion Criteria
* Presence of an understanding deficit (aphasia) evaluated by the team of professionals who recruit participants in the hospital.
* Presence of spatial neglect evaluated with line cancellation and line bisection tests.
* Presence of motor deficits in both upper limbs that impedes to complete the ADL tasks.
* Total score in MMSE\<18
18 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad de Granada
OTHER
María Rodríguez Bailón
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
María Rodríguez Bailón
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
María Jesús Funes-Molina, Professor
Role: PRINCIPAL_INVESTIGATOR
Facultad de Psicología (Departamento de Psicología Experimental) - Campus de Cartuja s/n, Granada, 18071
References
Explore related publications, articles, or registry entries linked to this study.
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
Giovannetti T, Libon DJ, Hart T. Awareness of naturalistic action errors in dementia. J Int Neuropsychol Soc. 2002 Jul;8(5):633-44. doi: 10.1017/s135561770280131x.
Prigatano GP, Bruna O, Mataro M, Munoz JM, Fernandez S, Junque C. Initial disturbances of consciousness and resultant impaired awareness in Spanish patients with traumatic brain injury. J Head Trauma Rehabil. 1998 Oct;13(5):29-38. doi: 10.1097/00001199-199810000-00005.
Forde EM, Humphreys GW, Remoundou M. Disordered knowledge of action order in action disorganisation syndrome. Neurocase. 2004 Feb;10(1):19-28. doi: 10.1080/13554790490960459.
Schmidt J, Fleming J, Ownsworth T, Lannin NA. Video feedback on functional task performance improves self-awareness after traumatic brain injury: a randomized controlled trial. Neurorehabil Neural Repair. 2013 May;27(4):316-24. doi: 10.1177/1545968312469838. Epub 2012 Dec 27.
Rodriguez-Bailon M, Montoro-Membila N, Garcia-Moran T, Arnedo-Montoro ML, Funes Molina MJ. Preliminary cognitive scale of basic and instrumental activities of daily living for dementia and mild cognitive impairment. J Clin Exp Neuropsychol. 2015;37(4):339-53. doi: 10.1080/13803395.2015.1013022. Epub 2015 Mar 25.
Forde EM, Humphreys GW. Dissociations in routine behaviour across patients and everyday tasks. Neurocase. 2002;8(1-2):151-67. doi: 10.1093/neucas/8.1.151.
Sirigu A, Zalla T, Pillon B, Grafman J, Agid Y, Dubois B. Selective impairments in managerial knowledge following pre-frontal cortex damage. Cortex. 1995 Jun;31(2):301-16. doi: 10.1016/s0010-9452(13)80364-4.
Sirigu A, Zalla T, Pillon B, Grafman J, Agid Y, Dubois B. Encoding of sequence and boundaries of scripts following prefrontal lesions. Cortex. 1996 Jun;32(2):297-310. doi: 10.1016/s0010-9452(96)80052-9.
Torralva T, Roca M, Gleichgerrcht E, Lopez P, Manes F. INECO Frontal Screening (IFS): a brief, sensitive, and specific tool to assess executive functions in dementia. J Int Neuropsychol Soc. 2009 Sep;15(5):777-86. doi: 10.1017/S1355617709990415. Epub 2009 Jul 28.
Toglia J, Kirk U. Understanding awareness deficits following brain injury. NeuroRehabilitation. 2000;15(1):57-70.
Merchan-Baeza JA, Rodriguez-Bailon M, Ricchetti G, Navarro-Egido A, Funes MJ. Awareness of cognitive abilities in the execution of activities of daily living after acquired brain injury: an evaluation protocol. BMJ Open. 2020 Oct 26;10(10):e037542. doi: 10.1136/bmjopen-2020-037542.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PSI2016-80331-P
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.