- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03309930
Narrative Comprehension by People With Acquired Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
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).
o 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kelly K Knollman-Porter, PhD
- Phone Number: 7652653640
- Email: knollmkk@miamioh.edu
Study Contact Backup
- Name: Sarah Wallace, PhD
- Phone Number: 4123964219
- Email: wallaces@duq.edu
Study Locations
-
-
Ohio
-
Oxford, Ohio, United States, 45056
- Recruiting
- Miami University
-
Contact:
- Kelly K Knollman-Porter, PhD
- Phone Number: 765-265-3640
- Email: knollmkk@miamioh.edu
-
Contact:
- Susan Brehm, PhD
- Phone Number: 513-529-2553
- Email: bakerse1@miamioh.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Comprehension Acquired Brain Injury
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 .
|
Comprehension accuracy across conditions will be assessed over 1 to 2 days.
|
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 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comprehension Generalization
Time Frame: measured 1 week and 4 weeks post termination of treatment
|
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 1 week and 4 weeks post termination of treatment
|
Perceived Comprehension Accuracy
Time Frame: measured 1 week and 4 weeks post termination of treatment
|
Participants will rate the accuracy and ease of comprehension of the sentences from each condition using a 5 point Likert scale.
|
measured 1 week and 4 weeks post termination of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kelly K Knollman-Porter, PhD, Miami University
- Principal Investigator: Sarah Wallace, PhD, Duquesne University
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Craniocerebral Trauma
- Trauma, Nervous System
- Language Disorders
- Communication Disorders
- Speech Disorders
- Brain Injuries
- Wounds and Injuries
- Brain Injuries, Traumatic
- Aphasia
Other Study ID Numbers
- #01377r
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
Queen Mary University of LondonCompleted
-
Northeastern UniversityBrandeis UniversityRecruitingTraumatic Brain Injury | Mild Traumatic Brain Injury | TBI | Moderate Traumatic Brain InjuryUnited States
Clinical Trials on Comprehension Acquired Brain Injury
-
PfizerIn Expanded Access, treating physicians are the SponsorAvailableSevere Uncontrolled Atopic Dermatitis
-
University of AlbertaAlberta Health services; MitacsNot yet recruitingStroke | Traumatic Brain Injury | Acquired Brain InjuryCanada
-
PfizerActive, not recruitingDermatitis, AtopicChina, United States, Spain, Taiwan, Germany, Australia, Canada, Hungary, Korea, Republic of, Poland, Serbia, Bulgaria, Czechia, Japan, Latvia, United Kingdom, Belgium, Israel, Italy, Finland, Mexico, Romania, Slovakia, Argentina, Brazil, Chil... and more
-
Virginia Commonwealth UniversityCompletedTraumatic Brain Injury | Acquired Brain InjuryUnited States
-
University Hospital, AngersUnknown
-
University of CopenhagenRigshospitalet, Denmark; Sygekassernes Helsefond; Aase and Ejnar Danielsens FoundationCompletedSocioeconomic Status | Education | Mild Traumatic Brain Injury | Concussion, Mild | Marriage | Sickness Absence | Academic Achievement | Income | Marital Status | Specific Academic or Work InhibitionDenmark
-
Taipei Medical University Shuang Ho HospitalChang Gung Memorial HospitalUnknownDementia | Alzheimer Disease | Traumatic Brain InjuryTaiwan
-
Umraniye Education and Research HospitalCompletedBrain InjuriesTurkey
-
Università degli Studi dell'InsubriaUnknown
-
Rehabilitation Hospital of IndianaCompletedTraumatic Brain Injury | Coping SkillsUnited States