AphasiaNCT04543084
Home Program Practice for People With Language Disorders After Stroke
A study testing Logbook in people with Aphasia and Stroke, run by Duquesne University at 1 site in United States.
Trial summary
Logbooks are one of the most commonly used methods to both support and track adherence in research studies. This study will look at using logbooks to support adherence to reading practice for individuals with post-stroke aphasia. It is thought that using a logbook will increase practice time. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Logbook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 6 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 6 months post left hemisphere stroke with a diagnosis of aphasia
- must have self-reported interest in working to improve reading comprehension
- access to the Internet
- speak English as a primary language
Who cannot join
- significant visual or hearing impairment as determined by "aphasia-friendly" and age-appropriate screening
- actively receiving speech-language pathology services in which computerized or reading comprehension home practice activities are assigned/requested
- severe auditory comprehension impairment that limits understanding of one-step directions (i.e., Western Aphasia Battery-Revised sequential commands subtest score below 8).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Home Program Practice for People With Language Disorders After Stroke
Logbooks are one of the most commonly used methods to both support and track adherence in research studies. This study will look at using logbooks to support adherence to reading practice for individuals with post-stroke aphasia. It is thought that using a logbook will increase practice time.
- Being tested
- Logbook
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LogbookBehavioural
Participants will record practice in a logbook.
| Study group | Role | What they receive |
|---|---|---|
| Single-Subject Design | Other | Each participant will go through a baseline phase and then an intervention phase. Receives: Behavioral: Logbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in minutes of practice
The number of minutes practiced
Measured: Up to 11 weeks
Change in percentage of adherence to practice goal
The amount of practice compared to the goal
Measured: Up to 11 weeks
Secondary outcomes (1)
Reading comprehension
As measured by performance on the Reading Comprehension Battery for Aphasia-2 (RCBA-2). A higher score is better.
Measured: At first session and at last session time in between up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start22 Jan 2021
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-subject Design
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena V. Donoso Brown, PhD, Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543084
- Sponsor's protocol ID
- 2019/12/11
- Status last verified
- Aug 2023
- First submitted
- 27 Aug 2020
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Home Program Practice for People With Language Disorders After Stroke
- ClinicalTrials.gov ID
- NCT04543084
- Acronym / sponsor ID
- 2019/12/11
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 9 Sep 2020 (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.
Logbooks are one of the most commonly used methods to both support and track adherence in research studies. This study will look at using logbooks to support adherence to reading practice for individuals with post-stroke aphasia. It is thought that using a logbook will increase practice time.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-subject Design
| Arm | Type | Receives |
|---|---|---|
| Single-Subject Design | Other | Behavioral: LogbookEach participant will go through a baseline phase and then an intervention phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 6 months post left hemisphere stroke with a diagnosis of aphasia
- must have self-reported interest in working to improve reading comprehension
- access to the Internet
- speak English as a primary language
Key exclusion criteria (3 listed)
- significant visual or hearing impairment as determined by "aphasia-friendly" and age-appropriate screening
- actively receiving speech-language pathology services in which computerized or reading comprehension home practice activities are assigned/requested
- severe auditory comprehension impairment that limits understanding of one-step directions (i.e., Western Aphasia Battery-Revised sequential commands subtest score below 8).
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 |
|---|---|---|
| LogbookParticipants will record practice in a logbook. | Behavioural | Single-Subject Design |
Primary outcome
Change in minutes of practice
Time frame: Up to 11 weeks
The number of minutes practiced
Change in percentage of adherence to practice goal
Time frame: Up to 11 weeks
The amount of practice compared to the goal
1 secondary outcome
Reading comprehension
Time frame: At first session and at last session time in between up to 5 months
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 1 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Aphasia
Not yet recruiting
Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia
Expressive Aphasia, Aphasia Following Cerebral Infarction
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.
Elena V. Donoso Brown, PhD principal investigator
Duquesne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Logbook in people with Aphasia and Stroke, run by Duquesne University at 1 site in United States.
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 4 inclusion and 3 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 in minutes of practice (time frame: Up to 11 weeks). The study lists 2 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 1 Sep 2023.