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Completed

NCT Number: NCT06451731

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

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • acquired brain-damage
  • presence of aphasia

Exclusion criteria

  • global aphasia
  • undergoing another treatment for aphasia

Treatment and study plan

PHOLEXSEM

Behavioral

Phonological, Lexical, and Semantic training

PACE

Behavioral

See arm description

Primary outcomes

  1. Change from baseline in the Neuropsychological Examination of Language (ENPA)

    Time frame: At baseline and immediately after the intervention.

    A test for aphasia assessment in the Italian population

  2. Change from baseline in phonemic fluency

    Time frame: At baseline and immediately after the intervention.

    To assess lexical retrieval based on a letter

  3. Change from baseline in semantic fluency

    Time frame: At baseline and immediately after the intervention.

    To assess lexical retrieval based on a semantic category

  4. Change from baseline in syntagma repetition

    Time frame: At baseline and immediately after the intervention.

    The syntagma repetition test from the Aachner Aphasie Test (AAT)

  5. Change from baseline in the auditory digit span

    Time frame: At baseline and immediately after the intervention.

    To assess auditory verbal short-term memory

  6. Change from baseline in the word repetition span

    Time frame: At baseline and immediately after the intervention.

    To assess auditory verbal short-term memory, with words stimuli

  7. Change from baseline in the Token Test

    Time frame: At baseline and immediately after the intervention.

    To assess auditory language comprehension

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: PHOLEXSEM

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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