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

NCT06451731 | Completed

• 1 other identifier: 25C501
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aphasia, Acquired; Stroke; Anomia

Outcome Measures

Primary Outcomes (7)

• 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.

Study Arms (2)

PHOLEXSEM

EXPERIMENTAL

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

PACE

ACTIVE COMPARATOR

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

Interventions

PHOLEXSEM BEHAVIORAL

Phonological, Lexical, and Semantic training

PHOLEXSEM

PACE BEHAVIORAL

See arm description

PACE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acquired brain-damage
• presence of aphasia

You may not qualify if:

• global aphasia
• undergoing another treatment for aphasia

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

MeSH Terms

Conditions

Aphasia; Stroke; Anomia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 11, 2024
• Study Start: June 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share