Aphasia, AcquiredPHOLEXSEMNCT06451731
Rehabilitation of Post-stroke Aphasia by Targeting Phonological, and Lexico-semantic Deficits With Speech Output Tasks
A study testing PHOLEXSEM and PACE in people with Aphasia, Acquired and Stroke, run by Istituto Auxologico Italiano.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aphasia, Acquired, Stroke, Anomia
- What is being tested?
- PHOLEXSEM and PACE
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acquired brain-damage
- presence of aphasia
Who cannot join
- global aphasia
- undergoing another treatment for aphasia
About this study
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
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.
Read more
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
- Being tested
- PHOLEXSEM, PACE
- Medical subject headings
- Aphasia, Stroke, Anomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHOLEXSEMBehavioural
Phonological, Lexical, and Semantic training
PACEBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: PACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Neuropsychological Examination of Language (ENPA)
A test for aphasia assessment in the Italian population
Measured: At baseline and immediately after the intervention.
Change from baseline in phonemic fluency
To assess lexical retrieval based on a letter
Measured: At baseline and immediately after the intervention.
Change from baseline in semantic fluency
To assess lexical retrieval based on a semantic category
Measured: At baseline and immediately after the intervention.
Change from baseline in syntagma repetition
The syntagma repetition test from the Aachner Aphasie Test (AAT)
Measured: At baseline and immediately after the intervention.
Change from baseline in the auditory digit span
To assess auditory verbal short-term memory
Measured: 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
Measured: At baseline and immediately after the intervention.
Change from baseline in the Token Test
To assess auditory language comprehension
Measured: At baseline and immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jun 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, AcquiredStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451731
- Sponsor's protocol ID
- 25C501
- Acronym
- PHOLEXSEM
- Status last verified
- Jun 2024
- First submitted
- 16 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available on Zenodo upon request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06451731
- Acronym / sponsor ID
- PHOLEXSEM / 25C501
- Conditions
- Aphasia, Acquired, Stroke, Anomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHOLEXSEM | Experimental | Behavioral: PHOLEXSEMEach 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. |
| PACE | Active comparator | Behavioral: PACEThree 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acquired brain-damage
- presence of aphasia
Key exclusion criteria (2 listed)
- global aphasia
- undergoing another treatment for aphasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHOLEXSEMPhonological, Lexical, and Semantic training | Behavioural | PHOLEXSEM |
| PACESee arm description | Behavioural | PACE |
Primary outcome
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
Change from baseline in phonemic fluency
Time frame: At baseline and immediately after the intervention.
To assess lexical retrieval based on a letter
Change from baseline in semantic fluency
Time frame: At baseline and immediately after the intervention.
To assess lexical retrieval based on a semantic category
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)
Change from baseline in the auditory digit span
Time frame: At baseline and immediately after the intervention.
To assess auditory verbal short-term memory
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
Change from baseline in the Token Test
Time frame: At baseline and immediately after the intervention.
To assess auditory language comprehension
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Yes. Data will be made available on Zenodo upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PHOLEXSEM and PACE in people with Aphasia, Acquired and Stroke, run by Istituto Auxologico Italiano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Neuropsychological Examination of Language (ENPA) (time frame: At baseline and immediately after the intervention.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.