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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Aphasia, Acquired; Anomia
• Intervention / Treatment: Behavioral: PHOLEXSEM; Behavioral: PACE

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• acquired brain-damage
• presence of aphasia

Exclusion Criteria:

• global aphasia
• undergoing another treatment for aphasia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PHOLEXSEM; Each session lasted 30 minutes, and comprised three sections, each lasting 10 minutes: Repetition, Semantic Feature Analysis (SFA), and Lexical retrieval. Repetition: 50 items for different kind of stimuli including: syllables, 2-syllable words and non-words; 2-syllable words and non-words with one consonant cluster; 3-syllable words and non-words; 3-syllable words and non-words with one consonant cluster, nuclear phrases. SFA: stimuli were 46 pictures of nouns, including living and non-living objects, controlled for frequency of use. Lexical retrieval phase: the patient was given three fluency tasks: a) 4 min of phonemic recall, b) 4 min of semantic recall, and c) 2 min of verb recall.	Behavioral: PHOLEXSEM; Phonological, Lexical, and Semantic training
Active Comparator: PACE; Three decks of cards - diversified by frequency of use - depicting nouns, were presented in sets of 4 cards each. In an exchange modality, the task consisted in understanding the noun chosen by the patient and, in turn, by the rehabilitator. Any communicative modality (oral, gestural, verbal, graphic) was allowed. Word difficulty was graded based on the frequency of use and semantic proximity or distance between target and distractors.	Behavioral: PACE; See arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Change from baseline in phonemic fluency	To assess lexical retrieval based on a letter	At baseline and immediately after the intervention.
Change from baseline in semantic fluency	To assess lexical retrieval based on a semantic category	At baseline and immediately after the intervention.
Change from baseline in syntagma repetition	The syntagma repetition test from the Aachner Aphasie Test (AAT)	At baseline and immediately after the intervention.
Change from baseline in the auditory digit span	To assess auditory verbal short-term memory	At baseline and immediately after the intervention.
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.
Change from baseline in the Token Test	To assess auditory language comprehension	At baseline and immediately after the intervention.

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stroke; Aphasia
• Other Study ID Numbers: 25C501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available on Zenodo upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No