Sports Related ConcussionNCT07884604
Concussion Goody Bag Study
An observational study of Sports Related Concussion, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
For the pilot study, thirty eligible participants will be provided a concussion goody bag at their initial concussion evaluation visit. Each goody bag consists of 12 items, with a letter briefly describing the intended purpose for each item. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Sports Related Concussion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2019
- Phase
- Observational
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be recruited from concussion clinics at the institution main hospital and satellite clinics.
Who may be able to join
- has a sports related concussion
- between the ages of 6-17 years
- is presenting to our clinic within three weeks of the concussion
Who cannot join
- has a history of prior diagnosed concussion
- has a history of headache (migraine or non-migraine)
- has a history of learning disability
- has Attention Deficit Disorder (ADD)
- has a history of anxiety, depression, or bipolar mood disorder
- is non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, 60611
About this study
Official title: Evaluation of Low-Level Activity Intervention in Pediatric Concussion Patients
For the pilot study, thirty eligible participants will be provided a concussion goody bag at their initial concussion evaluation visit. Each goody bag consists of 12 items, with a letter briefly describing the intended purpose for each item. Each participant will listen to a scripted tutorial by the research personnel, explaining the goody bag and why they are receiving it. Per standard of care, participants will return to clinic within 1-2 weeks for a follow up visit, at which time, they will complete a short questionnaire to assess overall usefulness of the bag, as well as individual rankings on how often they used each specific item. If the participant did not use any items, they will complete an additional question, describing why that item was not used, for each unused item. Also, the participants will be asked if they felt any additional items would have been helpful to them. Investigators expect these questionnaires to provide valuable insight from our patient perspectives about post-concussion care.
- Conditions
- Sports Related Concussion
- Keywords
- Concussion
- Medical subject headings
- Brain Concussion
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of participant opinions on the usefulness of a concussion goody bag.
Participants will be provided a concussion goody bag at their initial concussion evaluation visit.
At a participant's return visit to clinic, they are surveyed on the overall usefulness of the goody-bag and it's contents.
The survey utilizes a subjective scale. The scale of usefulness is measured from [1-5] with 1 being "Not Helpful" and 5 being "Very Helpful"
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2015
- Primary completionMay 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Poor feasibility of project recruitment and execution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Related ConcussionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884604
- Sponsor's protocol ID
- IRB 2015-526
- Status last verified
- Oct 2026
- First submitted
- 26 Jan 2016
- Last updated
- 20 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low-Level Activity Intervention in Pediatric Concussion Patients
- ClinicalTrials.gov ID
- NCT07884604
- Acronym / sponsor ID
- IRB 2015-526
- Conditions
- Sports Related Concussion
- Keywords
- Concussion
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Poor feasibility of project recruitment and execution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Oct 2026 (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.
For the pilot study, thirty eligible participants will be provided a concussion goody bag at their initial concussion evaluation visit. Each goody bag consists of 12 items, with a letter briefly describing the intended purpose for each item. Each participant will listen to a scripted tutorial by the research personnel, explaining the goody bag and why they are receiving it. Per standard of care, participants will return to clinic within 1-2 weeks for a follow up visit, at which time, they will complete a short questionnaire to assess overall usefulness of the bag, as well as individual rankings on how often they used each specific item. If the participant did not use any items, they will complete an additional question, describing why that item was not used, for each unused item. Also, the participants will be asked if they felt any additional items would have been helpful to them. Investigators expect these questionnaires to provide valuable insight from our patient perspectives about post-concussion care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be recruited from concussion clinics at the institution main hospital and satellite clinics.
Key inclusion criteria (3 listed)
- has a sports related concussion
- between the ages of 6-17 years
- is presenting to our clinic within three weeks of the concussion
Key exclusion criteria (6 listed)
- has a history of prior diagnosed concussion
- has a history of headache (migraine or non-migraine)
- has a history of learning disability
- has Attention Deficit Disorder (ADD)
- has a history of anxiety, depression, or bipolar mood disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of participant opinions on the usefulness of a concussion goody bag.
Time frame: 3 weeks
Participants will be provided a concussion goody bag at their initial concussion evaluation visit. At a participant's return visit to clinic, they are surveyed on the overall usefulness of the goody-bag and it's contents. The survey utilizes a subjective scale. The scale of usefulness is measured from [1-5] with 1 being "Not Helpful" and 5 being "Very Helpful"
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sports Related Concussion, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 20 Oct 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of participant opinions on the usefulness of a concussion goody bag. (time frame: 3 weeks). 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 20 Oct 2026.