Pediatric ALLNCT04248218
Concussion Active Rehabilitation
A study testing Active Rehabilitation Group/Case in people with Pediatric ALL and Concussion, Mild, run by Children's National Research Institute at 1 site in United States.
Trial summary
In this study, the investigator plans a randomized trial of active rehabilitation and standard care for acute concussion management. The investigator hypothesizes that patients with acute concussions managed with active rehabilitation will have decreased risk of prolonged concussion symptoms. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL, Concussion, Mild, Concussion, Brain
- What is being tested?
- Active Rehabilitation Group/Case
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2019to 30 Jun 2022
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient diagnosed with an acute concussion within 48 hours
- Patient greater than 8 and less than 19 years old
Who cannot join
- Major psychiatric diagnosis (bipolar disorder, major depression, does NOT include ADHD/ADD)
- Cognitive delay
- GCS < 14
- positive findings on head CT
- Any patient with intracranial surgery, pathology or instrumentation (e.g. VP shunt, brain tumor etc)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions
In this study, the investigator plans a randomized trial of active rehabilitation and standard care for acute concussion management. The investigator hypothesizes that patients with acute concussions managed with active rehabilitation will have decreased risk of prolonged concussion symptoms.
Read the detailed description
Specific Aims:
To compare the risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort after an acute concussion.
To determine if active rehabilitation compared to routine care reduces the risk of PCS for high-risk patients.
This is a prospective randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Patients 8-18 years old with an acute concussion diagnosis will be eligible. All patients will receive pedometers to monitor their activity levels. If the patient is in the control group the patient will receive standard concussion management per the treating ED physician. Patients in the active rehabilitation group will receive instructions based on the latest CDC concussion management guidelines that specify a symptom-limited progressive return to full activities. This group will be instructed to take at least 10,000 steps a day for five days on their pedometers.
One to five days after the ED concussion diagnosis a trained research coordinator will call all subjects to reinforce the management plan.
28 to 32 days post ED concussion diagnosis, research assistants will contact subjects via email or phone call to complete the concussion symptoms inventory.
- Being tested
- Active Rehabilitation Group/Case
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Rehabilitation Group/CaseBehavioural
If the patient is in the active rehabilitation group, the patient will receive instructions based on the latest CDC concussion management guidelines that specify a symptom-limited progressive return to full activities. This group will be instructed to take at least 10,000 steps a day for five days on their pedometers. In addition, they will also watch a two-minute video by the PI and research team reinforcing the active rehabilitation instructions.
| Study group | Role | What they receive |
|---|---|---|
| Normal/Control | No intervention | Control Group/Standard Care |
| Active Rehabilitation Group/Case | Active comparator | Active Rehabilitation Cohort/Intervention Receives: Behavioral: Active Rehabilitation Group/Case |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will measure and compare the relative risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort one month after an acute concussion.
We hypothesize that subjects managed with active rehabilitation post an acute concussion will have a 20% decreased relative risk of PCS compared to those managed with standard care.
Measured: 28 to 32 days post Emergency Department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start12 Aug 2019
- Primary completion30 Jan 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. The randomization plan will include randomization based on sex. Group A: active care Group B: routine/standard care
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Root, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248218
- Sponsor's protocol ID
- Pro0012220
- Status last verified
- Aug 2022
- First submitted
- 3 Jan 2020
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For the study, researchers will collect the age, gender, past medical history and through surveys, past, present and future symptoms after a head injury. This information will be used to determine which age groups are at risk and which constellation of symptoms persist following an acute head injury. All research documents and PHI will be kept in a locked cabinet and a password protected RedCap database that only study staff personnel have access to. No data will be shared until manuscript is written, but will only be shared in manuscript and not in individual data. If significant adverse data is found for a patient, the Lead PI will discuss with the subject and primary care physician.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions
- ClinicalTrials.gov ID
- NCT04248218
- Acronym / sponsor ID
- Pro0012220
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 30 Jan 2020 (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.
In this study, the investigator plans a randomized trial of active rehabilitation and standard care for acute concussion management. The investigator hypothesizes that patients with acute concussions managed with active rehabilitation will have decreased risk of prolonged concussion symptoms.
Detailed description
Specific Aims:
To compare the risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort after an acute concussion.
To determine if active rehabilitation compared to routine care reduces the risk of PCS for high-risk patients.
This is a prospective randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Patients 8-18 years old with an acute concussion diagnosis will be eligible. All patients will receive pedometers to monitor their activity levels. If the patient is in the control group the patient will receive standard concussion management per the treating ED physician. Patients in the active rehabilitation group will receive instructions based on the latest CDC concussion management guidelines that specify a symptom-limited progressive return to full activities. This group will be instructed to take at least 10,000 steps a day for five days on their pedometers.
One to five days after the ED concussion diagnosis a trained research coordinator will call all subjects to reinforce the management plan.
28 to 32 days post ED concussion diagnosis, research assistants will contact subjects via email or phone call to complete the concussion symptoms inventory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. The randomization plan will include randomization based on sex. Group A: active care Group B: routine/standard care
| Arm | Type | Receives |
|---|---|---|
| Normal/Control | No intervention | –Control Group/Standard Care |
| Active Rehabilitation Group/Case | Active comparator | Behavioral: Active Rehabilitation Group/CaseActive Rehabilitation Cohort/Intervention |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patient diagnosed with an acute concussion within 48 hours
- Patient greater than 8 and less than 19 years old
Key exclusion criteria (5 listed)
- Major psychiatric diagnosis (bipolar disorder, major depression, does NOT include ADHD/ADD)
- Cognitive delay
- GCS < 14
- positive findings on head CT
- Any patient with intracranial surgery, pathology or instrumentation (e.g. VP shunt, brain tumor etc)
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 |
|---|---|---|
| Active Rehabilitation Group/CaseIf the patient is in the active rehabilitation group, the patient will receive instructions based on the latest CDC concussion management guidelines that specify a symptom-limited progressive return to full activities. This group will be instructed to take at least 10,000 steps a day for five days on their pedometers. In addition, they will also watch a two-minute video by the PI and research team reinforcing the active rehabilitation instructions. | Behavioural | Active Rehabilitation Group/Case |
Primary outcome
We will measure and compare the relative risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort one month after an acute concussion.
Time frame: 28 to 32 days post Emergency Department
We hypothesize that subjects managed with active rehabilitation post an acute concussion will have a 20% decreased relative risk of PCS compared to those managed with standard care.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: No. For the study, researchers will collect the age, gender, past medical history and through surveys, past, present and future symptoms after a head injury. This information will be used to determine which age groups are at risk and which constellation of symptoms persist following an acute head injury. All research documents and PHI will be kept in a locked cabinet and a password protected RedCap database that only study staff personnel have access to. No data will be shared until manuscript is written, but will only be shared in manuscript and not in individual data. If significant adverse data is found for a patient, the Lead PI will discuss with the subject and primary care physician.
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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?
A study testing Active Rehabilitation Group/Case in people with Pediatric ALL and Concussion, Mild, run by Children's National Research Institute 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 30 Aug 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
We will measure and compare the relative risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort one month after an acute concussion. (time frame: 28 to 32 days post Emergency Department). 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 30 Aug 2022.