Brain InjuriesCVDNCT01417468
How Well do Patients With Traumatic Brain Injury Learn New Material Using Learning Styles in Online Science Classrooms?
A study testing CLSI, MI, CR and CLSI - Unknown in people with Brain Injuries and Brain Injuries, Traumatic, run by Center for Vision Development, New Market, Maryland at 1 site in United States.
Trial summary
The purpose of this study is to determine whether learning styles are effective in the treatment of traumatic brain injury (TBI) in an educational environment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Brain Injuries, Brain Injuries, Traumatic, Injury, Brain, Traumatic
- What is being tested?
- CLSI, MI, CR and CLSI - Unknown
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2013
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People who have been diagnosed with Mild Traumatic Brain Injury (TBI).
- People who are able to understand and sign an informed consent form.
- People who have no other known neurological disorder (e.g. aphasia, stroke).
- All participants must be 18-50 years old.
- Be able to speak and understand English, and
- Have use of a computer (Mac or Windows) and internet (www) access.
Who cannot join
- Don't meet the inclusion Criteria
- Other known neurological disorder (e.g. aphasia, stroke).
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Vision Development - (Research is being conducted online)
New Market, Maryland, 21774-6279
About this study
Official title: Instructional Design Strategies to Support Adult Patients/Students (Civilian & Military) With Traumatic Brain Injury (TBI).
The purpose of this study is to determine whether learning styles are effective in the treatment of traumatic brain injury (TBI) in an educational environment.
Read the detailed description
The purpose of this study is to determine the learning outcome and effectiveness of instructional design strategy using Canfield's learning styles and Gardner's Multiple Intelligences to accommodate TBI-induced cognitive impairments in an online science learning environment.
- Conditions
- Brain Injuries, Brain Injuries, Traumatic, Injury, Brain, Traumatic, Traumatic Brain Injury, Brain Injury, Chronic
- Being tested
- CLSI, MI, CR, CLSI - Unknown
- Keywords
- Cognitive Rehabilitation, Learning Styles, Learning Modes, Learning Modalities, Multiple Intelligences, Educational Intervention, Instructional Design
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Brain Injury, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLSI, MI, CRBehavioural
Also called Canfield Learning Styles Inventory, Multiple Intelligences, Cognitive Rehabilitation
(CLSI) Canfield Learning Styles Inventory (MI) Multiple Intelligences (CR) Cognitive Rehabilitation
CLSI - UnknownBehavioural
Also called Canfield Learning Styles Inventory, Multiple Intelligences, Cognitive Rehabilitation
(CLSI) Canfield Learning Styles Inventory (MI) Multiple Intelligences (CR) Cognitive Rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| CLSI - Known | Experimental | Participants will be assigned to a specific learning group via the Canfield Learning Style Inventory (CLSI). Receives: Behavioral: CLSI, MI, CR |
| CLSI - Unknown | Active comparator | Participants will be assigned to a traditional learning group (Control). Receives: Behavioral: CLSI - Unknown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning Effectiveness
This study will explore the use of a cognitive rehabilitation approach as suggested by Gardner's Multiple Intelligences for its potential application to online course design for brain injured patients/students. It involves designing instruction for a science unit based on four of Canfield's learning styles.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2013 (estimated)
- Study completionDec 2013 (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 Brain InjuriesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Vision Development, New Market, Maryland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Pettinato, Center for Vision Development, New Market, Maryland
- Investigators
- Mark C. Pettinato, M.S., Principal investigator, Capella University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417468
- Sponsor's protocol ID
- CVDMaryland-001
- Acronym
- CVD
- Status last verified
- Dec 2012
- First submitted
- 13 Aug 2011
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Canfield, A. (1980). Learning styles inventory manual. Ann Arbor, MI: Humanics Media. Pashler, H.; McDaniel, M.; Rohrer, D.; Bjork, R. (2009).
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instructional Design Strategies to Support Adult Patients/Students (Civilian & Military) With Traumatic Brain Injury (TBI).
- ClinicalTrials.gov ID
- NCT01417468
- Acronym / sponsor ID
- CVD / CVDMaryland-001
- Conditions
- Brain Injuries, Brain Injuries, Traumatic, Injury, Brain, Traumatic, Traumatic Brain Injury, Brain Injury, Chronic
- Keywords
- Cognitive Rehabilitation, Learning Styles, Learning Modes, Learning Modalities, Multiple Intelligences, Educational Intervention, Instructional Design
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Center for Vision Development, New Market, MarylandUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 16 Aug 2011 (estimated)
- 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 study is to determine whether learning styles are effective in the treatment of traumatic brain injury (TBI) in an educational environment.
Detailed description
The purpose of this study is to determine the learning outcome and effectiveness of instructional design strategy using Canfield's learning styles and Gardner's Multiple Intelligences to accommodate TBI-induced cognitive impairments in an online science learning environment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLSI - Known | Experimental | Behavioral: CLSI, MI, CRParticipants will be assigned to a specific learning group via the Canfield Learning Style Inventory (CLSI). |
| CLSI - Unknown | Active comparator | Behavioral: CLSI - UnknownParticipants will be assigned to a traditional learning group (Control). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- People who have been diagnosed with Mild Traumatic Brain Injury (TBI).
- People who are able to understand and sign an informed consent form.
- People who have no other known neurological disorder (e.g. aphasia, stroke).
- All participants must be 18-50 years old.
- Be able to speak and understand English, and
Key exclusion criteria (2 listed)
- Don't meet the inclusion Criteria
- Other known neurological disorder (e.g. aphasia, stroke).
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 |
|---|---|---|
| CLSI, MI, CRAlso: Canfield Learning Styles Inventory, Multiple Intelligences, Cognitive Rehabilitation(CLSI) Canfield Learning Styles Inventory (MI) Multiple Intelligences (CR) Cognitive Rehabilitation | Behavioural | CLSI - Known |
| CLSI - UnknownAlso: Canfield Learning Styles Inventory, Multiple Intelligences, Cognitive Rehabilitation(CLSI) Canfield Learning Styles Inventory (MI) Multiple Intelligences (CR) Cognitive Rehabilitation | Behavioural | CLSI - Unknown |
Primary outcome
Learning Effectiveness
Time frame: 3 Months
This study will explore the use of a cognitive rehabilitation approach as suggested by Gardner's Multiple Intelligences for its potential application to online course design for brain injured patients/students. It involves designing instruction for a science unit based on four of Canfield's learning styles.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
- BackgroundCanfield, A. (1980). Learning styles inventory manual. Ann Arbor, MI: Humanics Media. Pashler, H.; McDaniel, M.; Rohrer, D.; Bjork, R. (2009).
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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.
Mark C. Pettinato, M.S. principal investigator
Capella 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 CLSI, MI, CR and CLSI - Unknown in people with Brain Injuries and Brain Injuries, Traumatic, run by Center for Vision Development, New Market, Maryland 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 6 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: status not confirmed, as of the sponsor's last update on 18 Dec 2012. 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?
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?
Learning Effectiveness (time frame: 3 Months). 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 NCT01417468, 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 18 Dec 2012.