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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Kelly K Knollman-Porter, PhD contact

7652653640

knollmkk@miamioh.edu

Sarah Wallace, PhD contact

4123964219

wallaces@duq.edu

United States1 site, 1 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

    Recruiting

Other trials in United States

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).
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 groups in NCT03309930
Study groupRoleWhat they receive
Comprehension Acquired Brain InjuryExperimentalAll 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.

  1. 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.

  2. 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)
  1. 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

  2. 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.

  1. First posted16 Oct 2017
  2. Study start6 Oct 2017
  3. Primary completion6 Oct 2018 (estimated)
  4. Study completion6 Oct 2018 (estimated)

Resources

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)
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.

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.

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