Rehabilitation of Post-stroke Aphasia by Targeting Phonological, and Lexico-semantic Deficits With Speech Output Tasks

Stroke Clinical Trial

— PHOLEXSEM  

Official title:

Rehabilitation of Post-stroke Aphasia by a Single Protocol Targeting Phonological, Lexical, and Semantic Deficits With Speech Output Tasks: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06451731
• Other study ID #: 25C501
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2024
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aphasia in brain-damaged adult patients refers "to the more or less complete loss of the ability to use language" resulting from acquired brain damage, typically of the left hemisphere. The defective spoken output of persons with aphasia (PWA) has anomia as a main clinical manifestation. Improving anomia is a main goal of any language treatment. The present randomized controlled study assessed the effectiveness of a novel, two-week, rehabilitation protocol (PHOLEXSEM), focused on PHonological, SEmantic, and LExical deficits, aiming at improving lexical retrieval, and, generally, spoken output. The effects of the PHOLEXSEM treatment were compared to those of a control treatment, i.e., a Promoting Aphasics Communicative Effectiveness (PACE) protocol. Finally, we studied the effects of age, education, disease duration, brain lesion volume, and functional independence (Functional Idependence Measure, FIM) on the treatment-induced linguistic improvements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• acquired brain-damage
• presence of aphasia

Exclusion Criteria:

• global aphasia
• undergoing another treatment for aphasia

Related Conditions & MeSH terms

• Anomia
• Aphasia
• Aphasia, Acquired
• Stroke

Intervention

Behavioral:
• PHOLEXSEM
Phonological, Lexical, and Semantic training
• PACE
See arm description

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Neuropsychological Examination of Language (ENPA)	A test for aphasia assessment in the Italian population	At baseline and immediately after the intervention.
Primary	Change from baseline in phonemic fluency	To assess lexical retrieval based on a letter	At baseline and immediately after the intervention.
Primary	Change from baseline in semantic fluency	To assess lexical retrieval based on a semantic category	At baseline and immediately after the intervention.
Primary	Change from baseline in syntagma repetition	The syntagma repetition test from the Aachner Aphasie Test (AAT)	At baseline and immediately after the intervention.
Primary	Change from baseline in the auditory digit span	To assess auditory verbal short-term memory	At baseline and immediately after the intervention.
Primary	Change from baseline in the word repetition span	To assess auditory verbal short-term memory, with words stimuli	At baseline and immediately after the intervention.
Primary	Change from baseline in the Token Test	To assess auditory language comprehension	At baseline and immediately after the intervention.