AphasiaNCT03309930
Narrative Comprehension by People With Acquired Brain Injury
A study testing Comprehension Acquired Brain Injury in people with Aphasia and Traumatic Brain Injury, run by Miami University at 1 site in United States.
Trial summary
The purpose of this two phase study is to evaluate comprehension by people with acquired brain injury. The phase 1 portion of the study will examine comprehension of narrative paragraphs under 3 conditions: (a) written text only, (b) auditory output only (i.e., synthetic speech - David voice) or combined written text… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Aphasia, Traumatic Brain Injury
- What is being tested?
- Comprehension Acquired Brain Injury
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2017to 6 Oct 2018
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a clinical diagnosis of an acquired cognitive-communication impairment secondary to brain injury/stroke
- be 19-85 years of age
- be a least, 3 months post acquired brain injury
- primarily be a speaker of American English
Who cannot join
- exhibit the presence of a hearing impairment (i.e., prescribed hearing aid or failed hearing screening)
- demonstrate a vision or motor impairment that negatively influences study completion
- Study 2: have not access to wireless internet
- Study 2: exhibit and inability to independently (or with caregiver support) use the iPad device to complete the experimental tasks.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Miami University
Oxford, Ohio, 45056
Kelly K Knollman-Porter, PhD, 765-265-3640, knollmkk@miamioh.edu
Susan Brehm, PhD, 513-529-2553, bakerse1@miamioh.edu
About this study
The purpose of this two phase study is to evaluate comprehension by people with acquired brain injury. The phase 1 portion of the study will examine comprehension of narrative paragraphs under 3 conditions: (a) written text only, (b) auditory output only (i.e., synthetic speech - David voice) or combined written text and auditory output. The phase 2 portion of the study is to evaluate comprehension of sentences and paragraphs produced with computer generated (synthesized) speech and digitized natural speech after multiple exposures.
Read the detailed description
Part 1 Experimental Procedures: Written or Spoken Paragraph Level Measure o Participants will read or listen to 12 paragraph length narrative stories in the following 3 conditions: (a) written text only, (b) auditory output only (i.e., synthetic speech - David), or combined written text and auditory output. Participants will answer 10 questions regarding the information contained in each of the 12 stories. Anticipated time requirements: 1 to 2 sessions lasting about 60 minutes each.
Part 2 Experimental Procedures: Repeated Exposures
- Independent Training Session Practice
- To prepare the participants for independent practice (exposure) to the Synthetic 1 Condition during home training, the researchers will complete the first Independent Training Session with the participant within the clinic environment to verify participants understanding of the experimental procedure.
- The researchers will provide written instructions with simplified language and picture support to remind the participant of the practice instructions.
- Independent training sessions will utilize the Test of Silent Reading Efficiency and Comprehension (TOSREC) sentences recorded using the Synthetic 1 Voice Condition and the Digitized Voice Condition. TOSREC sentences are simple sentences presented at 1st, 2nd, and 3rd grade levels. Example sentence include: "A cow is an animal", and "Bears go to school". The participants will respond "yes" or "no" to each of 30 TOSREC sentences presented in a systematically randomized order. "Yes" and "no" responses will be recorded using active areas on the iPad created using a computer program designed for delivering stimuli (e.g., Blackboard, Canvas). All practice will be completed via the computer platform (e.g., Blackboard, Canvas) on the iPad. All 30 practice items should be completed in one sitting; however, the participant can take a break 5-10 minutes break during practice if needed.
- During this first Independent Training Session Practice, the researcher will provide the participant with verbal and written instructions regarding how to access each item and ensure that the participant understands the task prior to independent practice.
- Independent Training Sessions
- Participants will be given an iPad with Wi-Fi capabilities to use in their home (as well as a charger. Alternatively, participants may choose to use their own iPad.
- The researchers will instruct each participant to listen to and/or reading 15 sentences per day per condition (Synthetic 1 and Digitized Sentence presentations). The researchers will provide written instructions with simplified language and picture support to remind the participant of the practice instructions.
- The participants will respond "yes" or "no" to each of the 30 TOSREC sentences presented in a systematic randomized order. All 30 practice items should be completed in one sitting; however, the participant can take a 5-10 minute preach during practice if needed.
- Participants will receive feedback about overall percentage performance accuracy at the end of each daily session.
- All practice will be completed via the computer platform (e.g., Blackboard, CANVAS) on the iPad. Participants will practice for a period of two weeks (12 sessions). This is expected to take the participants no more than 15 minutes per day. The person will be asked to complete the practice up to 6 days per week. The participant will decide the days and times of practice as fits his or her schedule.
Post-Testing Sessions
- One Post-Testing Session will occur within 1 week after the last practice session ends. It will last about 60 minutes. Post-Testing tasks include responding to 45 yes/no TOSREC sentences (15 per 3 conditions), selecting a picture following the 45 Norman Rockwell sentence level comprehension task (15 per 3 conditions), and answering questions after listening to two QRI stories from one condition (Synthetic 1).
- Following completion of the procedure above, participants will rate the accuracy and ease of comprehension of the sentences from each condition using a 5-point Likert scale. These questions appear in Appendix G.
- The Maintenance Session will occur about 4 weeks after the last practice session ends. It will last approximately 60 minutes. The Maintenance Session tasks include responding to 45 yes/no TOSREC sentences (15 per 3 conditions), selecting a picture following the Norman Rockwell sentence level comprehension task (15 per 3 conditions), and answering questions after listening to two QI stories from one condition (Synthetic 1).
- Conditions
- Aphasia, Traumatic Brain Injury
- Being tested
- Comprehension Acquired Brain Injury
- Keywords
- comprehension, Strategies, repeated exposure
- Medical subject headings
- Aphasia, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehension Acquired Brain InjuryBehavioural
For study 1 participants will be exposed to 3 conditions as stated in previous descriptions and will last 1 to 2 sessions. Study 2 will begin with 1 session with the researcher lasting about 30 minutes. Then participants will be asked to complete practice at home for about 15 minutes each day for 2 weeks using a computer/iPad. Study 2 Post Testing and Maintenance Sessions 1 and 2: approximately 60 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| Comprehension Acquired Brain Injury | Experimental | All participants will be exposed to 3 conditions: (a) written text, (b) auditory output (synthetic speech), and combined conditions for study 1. For study 2 participants will be repeatedly exposed to synthetic speech output to determine the influence on comprehension. Participants are not required to participate in both studies. Receives: Behavioral: Comprehension Acquired Brain Injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension Across Conditions (Study 1 of 2)
Participants will answer 10 multiple choice questions regarding the information contained in each of the 12 stories presented in 3 conditions: (1) written text only (b) auditory output only and (c) combined written text and auditory output .
Measured: Comprehension accuracy across conditions will be assessed over 1 to 2 days.
Repeated Exposure to Digitized and Synthetic Speech (Study 2 of 2)
Participants will answer 30 yes/no questions per session. Comprehension percentage accuracy will be measured over the course of 2 weeks
Measured: 2 weeks
Secondary outcomes (2)
Comprehension Generalization
Participants will listen to two stories presented in synthetic, computer generated speech and answer comprehension questions about the content of the stories to determine auditory comprehension accuracy
Measured: measured 1 week and 4 weeks post termination of treatment
Perceived Comprehension Accuracy
Participants will rate the accuracy and ease of comprehension of the sentences from each condition using a 5 point Likert scale.
Measured: measured 1 week and 4 weeks post termination of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start6 Oct 2017
- Primary completion6 Oct 2018 (estimated)
- Study completion6 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- During Study 1 participants will be exposed to three different conditions: (a) written text only, (b) auditory synthetic speech output only and (c) a combined condition (written and auditory output). During Study 2 participants will be provided repeated exposure to synthetic speech. Participants can participate in 1 or both studies with 1 study results not being dependent on the other study. .
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miami University
- Sponsor type
- University, hospital or other
- Collaborators
- Duquesne University, University of Nebraska Lincoln, University of Arizona
- Responsible party
- Principal investigator, Kelly Knollman-Porter, Miami University
- Investigators
- Kelly K Knollman-Porter, PhD, Principal investigator, Miami UniversitySarah Wallace, PhD, Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309930
- Sponsor's protocol ID
- #01377r
- Status last verified
- Oct 2017
- First submitted
- 9 Oct 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing the data because of possible breach of privacy given the small number of local people with acquired brain injury/stroke.
Publications
Wagner R. K., Torgesen J. K., Rashotte C. A., Pearson N. A. (2010). Test of Silent Reading Efficiency and Comprehension (TOSREC) examiner's manual. Austin, TX: Pro-Ed.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrative Comprehension by People With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT03309930
- Acronym / sponsor ID
- #01377r
- Conditions
- Aphasia, Traumatic Brain Injury
- Keywords
- comprehension, Strategies, repeated exposure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Miami UniversityUniversity, hospital or other
- Collaborators
- Duquesne University, University of Nebraska Lincoln, University of Arizona
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 6 Oct 2018 (estimated)
- Study completion
- 6 Oct 2018 (estimated)
- First posted
- 16 Oct 2017 (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.
The purpose of this two phase study is to evaluate comprehension by people with acquired brain injury. The phase 1 portion of the study will examine comprehension of narrative paragraphs under 3 conditions: (a) written text only, (b) auditory output only (i.e., synthetic speech - David voice) or combined written text and auditory output. The phase 2 portion of the study is to evaluate comprehension of sentences and paragraphs produced with computer generated (synthesized) speech and digitized natural speech after multiple exposures.
Detailed description
Part 1 Experimental Procedures: Written or Spoken Paragraph Level Measure o Participants will read or listen to 12 paragraph length narrative stories in the following 3 conditions: (a) written text only, (b) auditory output only (i.e., synthetic speech - David), or combined written text and auditory output. Participants will answer 10 questions regarding the information contained in each of the 12 stories. Anticipated time requirements: 1 to 2 sessions lasting about 60 minutes each.
Part 2 Experimental Procedures: Repeated Exposures
- Independent Training Session Practice
- To prepare the participants for independent practice (exposure) to the Synthetic 1 Condition during home training, the researchers will complete the first Independent Training Session with the participant within the clinic environment to verify participants understanding of the experimental procedure.
- The researchers will provide written instructions with simplified language and picture support to remind the participant of the practice instructions.
- Independent training sessions will utilize the Test of Silent Reading Efficiency and Comprehension (TOSREC) sentences recorded using the Synthetic 1 Voice Condition and the Digitized Voice Condition. TOSREC sentences are simple sentences presented at 1st, 2nd, and 3rd grade levels. Example sentence include: "A cow is an animal", and "Bears go to school". The participants will respond "yes" or "no" to each of 30 TOSREC sentences presented in a systematically randomized order. "Yes" and "no" responses will be recorded using active areas on the iPad created using a computer program designed for delivering stimuli (e.g., Blackboard, Canvas). All practice will be completed via the computer platform (e.g., Blackboard, Canvas) on the iPad. All 30 practice items should be completed in one sitting; however, the participant can take a break 5-10 minutes break during practice if needed.
- During this first Independent Training Session Practice, the researcher will provide the participant with verbal and written instructions regarding how to access each item and ensure that the participant understands the task prior to independent practice.
- Independent Training Sessions
- Participants will be given an iPad with Wi-Fi capabilities to use in their home (as well as a charger. Alternatively, participants may choose to use their own iPad.
- The researchers will instruct each participant to listen to and/or reading 15 sentences per day per condition (Synthetic 1 and Digitized Sentence presentations). The researchers will provide written instructions with simplified language and picture support to remind the participant of the practice instructions.
- The participants will respond "yes" or "no" to each of the 30 TOSREC sentences presented in a systematic randomized order. All 30 practice items should be completed in one sitting; however, the participant can take a 5-10 minute preach during practice if needed.
- Participants will receive feedback about overall percentage performance accuracy at the end of each daily session.
- All practice will be completed via the computer platform (e.g., Blackboard, CANVAS) on the iPad. Participants will practice for a period of two weeks (12 sessions). This is expected to take the participants no more than 15 minutes per day. The person will be asked to complete the practice up to 6 days per week. The participant will decide the days and times of practice as fits his or her schedule.
Post-Testing Sessions
- One Post-Testing Session will occur within 1 week after the last practice session ends. It will last about 60 minutes. Post-Testing tasks include responding to 45 yes/no TOSREC sentences (15 per 3 conditions), selecting a picture following the 45 Norman Rockwell sentence level comprehension task (15 per 3 conditions), and answering questions after listening to two QRI stories from one condition (Synthetic 1).
- Following completion of the procedure above, participants will rate the accuracy and ease of comprehension of the sentences from each condition using a 5-point Likert scale. These questions appear in Appendix G.
- The Maintenance Session will occur about 4 weeks after the last practice session ends. It will last approximately 60 minutes. The Maintenance Session tasks include responding to 45 yes/no TOSREC sentences (15 per 3 conditions), selecting a picture following the Norman Rockwell sentence level comprehension task (15 per 3 conditions), and answering questions after listening to two QI stories from one condition (Synthetic 1).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- During Study 1 participants will be exposed to three different conditions: (a) written text only, (b) auditory synthetic speech output only and (c) a combined condition (written and auditory output). During Study 2 participants will be provided repeated exposure to synthetic speech. Participants can participate in 1 or both studies with 1 study results not being dependent on the other study. .
| Arm | Type | Receives |
|---|---|---|
| Comprehension Acquired Brain Injury | Experimental | Behavioral: Comprehension Acquired Brain InjuryAll participants will be exposed to 3 conditions: (a) written text, (b) auditory output (synthetic speech), and combined conditions for study 1. For study 2 participants will be repeatedly exposed to synthetic speech output to determine the influence on comprehension. Participants are not required to participate in both studies. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- have a clinical diagnosis of an acquired cognitive-communication impairment secondary to brain injury/stroke
- be 19-85 years of age
- be a least, 3 months post acquired brain injury
- primarily be a speaker of American English
Key exclusion criteria (4 listed)
- exhibit the presence of a hearing impairment (i.e., prescribed hearing aid or failed hearing screening)
- demonstrate a vision or motor impairment that negatively influences study completion
- Study 2: have not access to wireless internet
- Study 2: exhibit and inability to independently (or with caregiver support) use the iPad device to complete the experimental tasks.
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 |
|---|---|---|
| Comprehension Acquired Brain InjuryFor study 1 participants will be exposed to 3 conditions as stated in previous descriptions and will last 1 to 2 sessions. Study 2 will begin with 1 session with the researcher lasting about 30 minutes. Then participants will be asked to complete practice at home for about 15 minutes each day for 2 weeks using a computer/iPad. Study 2 Post Testing and Maintenance Sessions 1 and 2: approximately 60 minutes per session. | Behavioural | Comprehension Acquired Brain Injury |
Primary outcome
Comprehension Across Conditions (Study 1 of 2)
Time frame: Comprehension accuracy across conditions will be assessed over 1 to 2 days.
Participants will answer 10 multiple choice questions regarding the information contained in each of the 12 stories presented in 3 conditions: (1) written text only (b) auditory output only and (c) combined written text and auditory output .
Repeated Exposure to Digitized and Synthetic Speech (Study 2 of 2)
Time frame: 2 weeks
Participants will answer 30 yes/no questions per session. Comprehension percentage accuracy will be measured over the course of 2 weeks
2 secondary outcomes
Comprehension Generalization
Time frame: measured 1 week and 4 weeks post termination of treatment
Perceived Comprehension Accuracy
Time frame: measured 1 week and 4 weeks post termination of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- BackgroundWagner R. K., Torgesen J. K., Rashotte C. A., Pearson N. A. (2010). Test of Silent Reading Efficiency and Comprehension (TOSREC) examiner's manual. Austin, TX: Pro-Ed.
- Individual participant dataSharing planned: No. We will not be sharing the data because of possible breach of privacy given the small number of local people with acquired brain injury/stroke.
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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.
Kelly K Knollman-Porter, PhD principal investigator
Miami University
Sarah Wallace, 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 Comprehension Acquired Brain Injury in people with Aphasia and Traumatic Brain Injury, run by Miami 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 4 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: status not confirmed, as of the sponsor's last update on 16 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly K Knollman-Porter, PhD (7652653640, knollmkk@miamioh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension Across Conditions (Study 1 of 2) (time frame: Comprehension accuracy across conditions will be assessed over 1 to 2 days.). 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?
On the ClinicalTrials.gov record for NCT03309930, which also lists 1 linked publication.
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 16 Oct 2017.