Buckle FractureHM-PBFNCT06633094
Home Management of Pediatric Buckle Fractures
A study testing Educational videos in people with Buckle Fracture and Patient Satisfaction, run by Carilion Clinic at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine if a home management plan incorporating video education can effectively replace in-person visits for children aged 7-17 diagnosed with distal radius buckle fractures. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Buckle Fracture, Patient Satisfaction
- What is being tested?
- Educational videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 31 Dec 2024
- 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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any incoming pediatric orthopaedic referral containing the phrase: "distal radius fracture" "wrist fracture" or "buckle fracture
- A buckle fracture of the distal radius without opposite cortical break (an associated buckle fracture of the ulna is acceptable for inclusion)
- Age 5-17
- Access to a smartphone, tablet, or computer
- Access to internet to download or view videos
Who cannot join
- Other fractures
- Discontinuity of both cortices of the distal radius.
- Metabolic bone disease
- Developmental delay affecting assessment
- Inability to utilize technology to view videos or follow instructions
- Lack of internet or telephone access
- Family/caregiver inability to speak or read English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Clinic Orthopaedic Surgery
Roanoke, Virginia, 24014
About this study
Official title: Home Management of Pediatric Buckle Fractures: Can Video Education Replace In-Person Visits?
The goal of this clinical trial is to determine if a home management plan incorporating video education can effectively replace in-person visits for children aged 7-17 diagnosed with distal radius buckle fractures.
The main questions it aims to answer are:
Read more
Is a home management plan with video education non-inferior to in-person management for patient satisfaction? Is a home management plan superior to in-person management for reducing healthcare-related time, missed work/school, inappropriate care (e.g., rigid casting), and healthcare resource consumption? Researchers will compare the home management group to the in-person management group to see if video education can reduce healthcare costs and the burden on patients without compromising care quality.
Participants will:
Be randomized to either the in-person group or the video-based home management group.
Complete a pediatric PROMIS assessment at baseline and 6 weeks. Complete a satisfaction survey at the conclusion of the study.
Read the detailed description
Pediatric buckle fractures of the wrist are extremely common. In the U.S., these are often referred to a pediatric orthopaedic specialist, despite evidence that specialty follow-up is unnecessary. These unnecessary visits add to healthcare costs, especially for patients living in rural areas who must travel long distances to see specialists. Our group has been successful with short video-based education in prior work. In this study, the investigators aim to reduce the burden of care for buckle fracture patients and their parents/guardians. Our objective is to determine whether a home management plan centered around video education can replace in-person visits. Here, the investigators propose a prospective, randomized controlled non-inferiority study to determine if a home management plan incorporating video education can replace in-person visits for pediatric buckle fractures. This study has the potential to reduce the burden on patients and families who may have to travel long distances and miss school/work. In addition, this method of treatment has the potential to reduce healthcare costs and increase access for other patients with higher acuity medical needs.
Our current objective is to determine whether a home management plan centered around video education can effectively replace in-person visits.
Hypothesis 1: A home management plan for pediatric buckle fractures incorporating video education is non-inferior to in-person management for patient satisfaction.
Hypothesis 2: A home management plan for pediatric buckle fractures incorporating video education is superior to in-person management for time spent on healthcare activities, missed time from work, missed time from school, rate of inappropriate care (rigid casting and follow-up x-ray), level of health care resource consumption as measured by provider time spent on delivering care.
The investigators plan to perform a prospective, randomized controlled non-inferiority study to examine the effectiveness of educational videos on validated patient-reported outcomes.
Our study population will be composed of children who are diagnosed with a distal radius buckle fracture at Carilion Clinic. Subjects will be randomized to one of two groups: in-person management or home management through video education.
Incoming pediatric referrals containing the phrase: "distal radius fracture" "wrist fracture" or "buckle fracture" will be flagged and the x-rays will be reviewed within 4 business hours by one of the three pediatric orthopaedic surgeons on this study. If the fracture pattern meets inclusion criteria, the family will be offered the opportunity to enroll by the Clinical Research Coordinator/Clinical Research Assistant. Parent/guardians will acknowledge consent by secure electronic signature on REDCap. Children 7-17 years of age will be asked to assent.
Those randomized to the in-person group will meet with an Orthopaedic Surgeon at Carilion Clinic Institute for Orthopaedics and Neurosciences. the home management group will be given access to an educational video explaining the nature of buckle fractures and treatment. all participants will enroll in MyChart to allow for asynchronous messages. Participants from both groups will complete a pediatric PROMIS assessment at baseline and 6 weeks. Patients/guardians will complete a satisfaction survey.
- Conditions
- Buckle Fracture, Patient Satisfaction
- Being tested
- Educational videos
- Keywords
- Pediatric orthopedics, Distal radius fractures, Pediatric fractures, Fracture management, Patient education
- Medical subject headings
- Patient Satisfaction, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videosOther
Internet will be used to deliver educational videos to subjects enrolled in the home management arm of the study which will be available on the Carilion Clinic Orthopaedic Education YouTube Channel. This will consist of a prerecorded video made by the three pediatric orthopaedic surgeons on this study explaining the nature of buckle fractures and treatment. Participants will be sent a link to the video over email (an example of a similar video in clinical use at Carilion Orthopaedics and the script of the video can be found in the study document attached).
| Study group | Role | What they receive |
|---|---|---|
| In-person management | No intervention | In-person group will be followed with standard-of-care clinic visits scheduled with an pediatric orthopaedic Surgeon at Carilion Clinic Institute for Orthopaedics and Neurosciences. Participants will complete a pediatric PROMIS assessment at baseline and 6 weeks for . Patients/guardians will complete a satisfaction survey. |
| Home management | Experimental | Home-management group will be given access to an educational video explaining the nature of buckle fractures and treatment. all participants will enroll in MyChart to allow for asynchronous messages. Participants will complete a pediatric PROMIS assessment at baseline and 6 weeks. Patients/guardians will complete a satisfaction survey. Receives: Other: Educational videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric Short Form v2.0 - Physical Function Upper Extremity.
This pediatric PROMIS assessment will be filled out at baseline and 6 weeks. All responses will be recorded within the study's REDCap database.
Responses for each question:
Measured: Baseline to 6 week follow-up
Secondary outcomes (4)
Parent Satisfaction Survey
4 Questions:
A survey will be sent to the parents/guardians to obtain the following information:
- Satisfaction with their care, measures on a 5-point Likert scale:
- Participants will select: Strongly Disagree, Disagree, Neither Agree or Disagree, Agree, or Strongly Agree 2) Time spent on healthcare activities
- Recorded in minutes 3) Time missed from work
- Recorded in minutes 4) Time missed time from school.
- Recorded in minutes
Measured: Baseline to 6 week follow-up
Rigid Casting
Electronic medical record chart review will be performed to determine:
Rate of rigid casting
- Yes or No
Measured: Baseline to 6 week follow-up
Rate of follow-up X-rays
Electronic medical record chart review will be performed to determine: Number of x-rays ordered during follow-up care
Measured: Baseline to 6 week follow-up
Provider time spent on delivering care
Electronic medical record chart review will be performed to determine: Number of follow-up visits (minutes per session)
Measured: Baseline to 6 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Jun 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Buckle FractureStudies 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
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Peter J Apel, Carilion Clinic
- Investigators
- Peter J Apel, MD, PhD, Principal investigator, Carilion Clinic Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633094
- Sponsor's protocol ID
- 21-1491
- Acronym
- HM-PBF
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Landin LA. Epidemiology of children's fractures. J Pediatr Orthop B. 1997 Apr;6(2):79-83. doi: 10.1097/01202412-199704000-00002.
PubMed 9165435Bae DS, Howard AW. Distal radius fractures: what is the evidence? J Pediatr Orthop. 2012 Sep;32 Suppl 2:S128-30. doi: 10.1097/BPO.0b013e31824b2545.
PubMed 22890451Baig MN, Egan C. Improving Management of Paediatric Buckle Fracture in Orthopaedic Outpatients: A Completed Audit Loop. Cureus. 2017 Nov 8;9(11):e1829. doi: 10.7759/cureus.1829.
PubMed 29326858Koelink E, Boutis K. Paediatrician office follow-up of common minor fractures. Paediatr Child Health. 2014 Oct;19(8):407-12. doi: 10.1093/pch/19.8.407.
PubMed 25382996Symons S, Rowsell M, Bhowal B, Dias JJ. Hospital versus home management of children with buckle fractures of the distal radius. A prospective, randomised trial. J Bone Joint Surg Br. 2001 May;83(4):556-60. doi: 10.1302/0301-620x.83b4.11211.
PubMed 11380131Firmin F, Crouch R. Splinting versus casting of "torus" fractures to the distal radius in the paediatric patient presenting at the emergency department (ED): a literature review. Int Emerg Nurs. 2009 Jul;17(3):173-8. doi: 10.1016/j.ienj.2009.03.006. Epub 2009 May 7.
PubMed 19577205Boutis K. Common pediatric fractures treated with minimal intervention. Pediatr Emerg Care. 2010 Feb;26(2):152-7; quiz 158-62. doi: 10.1097/PEC.0b013e3181ce310c.
PubMed 20145510Koelink E, Schuh S, Howard A, Stimec J, Barra L, Boutis K. Primary Care Physician Follow-up of Distal Radius Buckle Fractures. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-2262. Epub 2015 Dec 10.
PubMed 26729537Plint AC, Perry JJ, Correll R, Gaboury I, Lawton L. A randomized, controlled trial of removable splinting versus casting for wrist buckle fractures in children. Pediatrics. 2006 Mar;117(3):691-7. doi: 10.1542/peds.2005-0801.
PubMed 16510648Davidson JS, Brown DJ, Barnes SN, Bruce CE. Simple treatment for torus fractures of the distal radius. J Bone Joint Surg Br. 2001 Nov;83(8):1173-5. doi: 10.1302/0301-620x.83b8.11451.
PubMed 11764434Williams BA, Palumbo NE, Phillips SA, Blakemore LC. What They Want - Caregiver and Patient Immobilization Preferences for Pediatric Buckle Fractures of the Wrist. Iowa Orthop J. 2020;40(1):83-90.
PubMed 32742213Heikkinen K, Helena LK, Taina N, Anne K, Sanna S. A comparison of two educational interventions for the cognitive empowerment of ambulatory orthopaedic surgery patients. Patient Educ Couns. 2008 Nov;73(2):272-9. doi: 10.1016/j.pec.2008.06.015.
PubMed 18678461Wright JE, Brown RR, Chadwick C, Karadaglis D. The use of the Internet by orthopaedic outpatients. J Bone Joint Surg Br. 2001 Nov;83(8):1096-7. doi: 10.1302/0301-620x.83b8.12390. No abstract available.
PubMed 11764418Yi PH, Ganta A, Hussein KI, Frank RM, Jawa A. Readability of arthroscopy-related patient education materials from the American Academy of Orthopaedic Surgeons and Arthroscopy Association of North America Web sites. Arthroscopy. 2013 Jun;29(6):1108-12. doi: 10.1016/j.arthro.2013.03.003.
PubMed 23726111Cotugna N, Vickery CE, Carpenter-Haefele KM. Evaluation of literacy level of patient education pages in health-related journals. J Community Health. 2005 Jun;30(3):213-9. doi: 10.1007/s10900-004-1959-x.
PubMed 15847246
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Management of Pediatric Buckle Fractures: Can Video Education Replace In-Person Visits?
- ClinicalTrials.gov ID
- NCT06633094
- Acronym / sponsor ID
- HM-PBF / 21-1491
- Conditions
- Buckle Fracture, Patient Satisfaction
- Keywords
- Pediatric orthopedics, Distal radius fractures, Pediatric fractures, Fracture management, Patient education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Oct 2024 (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.
The goal of this clinical trial is to determine if a home management plan incorporating video education can effectively replace in-person visits for children aged 7-17 diagnosed with distal radius buckle fractures.
The main questions it aims to answer are:
Is a home management plan with video education non-inferior to in-person management for patient satisfaction? Is a home management plan superior to in-person management for reducing healthcare-related time, missed work/school, inappropriate care (e.g., rigid casting), and healthcare resource consumption? Researchers will compare the home management group to the in-person management group to see if video education can reduce healthcare costs and the burden on patients without compromising care quality.
Participants will:
Be randomized to either the in-person group or the video-based home management group.
Complete a pediatric PROMIS assessment at baseline and 6 weeks. Complete a satisfaction survey at the conclusion of the study.
Detailed description
Pediatric buckle fractures of the wrist are extremely common. In the U.S., these are often referred to a pediatric orthopaedic specialist, despite evidence that specialty follow-up is unnecessary. These unnecessary visits add to healthcare costs, especially for patients living in rural areas who must travel long distances to see specialists. Our group has been successful with short video-based education in prior work. In this study, the investigators aim to reduce the burden of care for buckle fracture patients and their parents/guardians. Our objective is to determine whether a home management plan centered around video education can replace in-person visits. Here, the investigators propose a prospective, randomized controlled non-inferiority study to determine if a home management plan incorporating video education can replace in-person visits for pediatric buckle fractures. This study has the potential to reduce the burden on patients and families who may have to travel long distances and miss school/work. In addition, this method of treatment has the potential to reduce healthcare costs and increase access for other patients with higher acuity medical needs.
Our current objective is to determine whether a home management plan centered around video education can effectively replace in-person visits.
Hypothesis 1: A home management plan for pediatric buckle fractures incorporating video education is non-inferior to in-person management for patient satisfaction.
Hypothesis 2: A home management plan for pediatric buckle fractures incorporating video education is superior to in-person management for time spent on healthcare activities, missed time from work, missed time from school, rate of inappropriate care (rigid casting and follow-up x-ray), level of health care resource consumption as measured by provider time spent on delivering care.
The investigators plan to perform a prospective, randomized controlled non-inferiority study to examine the effectiveness of educational videos on validated patient-reported outcomes.
Our study population will be composed of children who are diagnosed with a distal radius buckle fracture at Carilion Clinic. Subjects will be randomized to one of two groups: in-person management or home management through video education.
Incoming pediatric referrals containing the phrase: "distal radius fracture" "wrist fracture" or "buckle fracture" will be flagged and the x-rays will be reviewed within 4 business hours by one of the three pediatric orthopaedic surgeons on this study. If the fracture pattern meets inclusion criteria, the family will be offered the opportunity to enroll by the Clinical Research Coordinator/Clinical Research Assistant. Parent/guardians will acknowledge consent by secure electronic signature on REDCap. Children 7-17 years of age will be asked to assent.
Those randomized to the in-person group will meet with an Orthopaedic Surgeon at Carilion Clinic Institute for Orthopaedics and Neurosciences. the home management group will be given access to an educational video explaining the nature of buckle fractures and treatment. all participants will enroll in MyChart to allow for asynchronous messages. Participants from both groups will complete a pediatric PROMIS assessment at baseline and 6 weeks. Patients/guardians will complete a satisfaction survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person management | No intervention | –In-person group will be followed with standard-of-care clinic visits scheduled with an pediatric orthopaedic Surgeon at Carilion Clinic Institute for Orthopaedics and Neurosciences. Participants will complete a pediatric PROMIS assessment at baseline and 6 weeks for . Patients/guardians will complete a satisfaction survey. |
| Home management | Experimental | Other: Educational videosHome-management group will be given access to an educational video explaining the nature of buckle fractures and treatment. all participants will enroll in MyChart to allow for asynchronous messages. Participants will complete a pediatric PROMIS assessment at baseline and 6 weeks. Patients/guardians will complete a satisfaction survey. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Any incoming pediatric orthopaedic referral containing the phrase: "distal radius fracture" "wrist fracture" or "buckle fracture
- A buckle fracture of the distal radius without opposite cortical break (an associated buckle fracture of the ulna is acceptable for inclusion)
- Age 5-17
- Access to a smartphone, tablet, or computer
- Access to internet to download or view videos
Key exclusion criteria (7 listed)
- Other fractures
- Discontinuity of both cortices of the distal radius.
- Metabolic bone disease
- Developmental delay affecting assessment
- Inability to utilize technology to view videos or follow instructions
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 |
|---|---|---|
| Educational videosInternet will be used to deliver educational videos to subjects enrolled in the home management arm of the study which will be available on the Carilion Clinic Orthopaedic Education YouTube Channel. This will consist of a prerecorded video made by the three pediatric orthopaedic surgeons on this study explaining the nature of buckle fractures and treatment. Participants will be sent a link to the video over email (an example of a similar video in clinical use at Carilion Orthopaedics and the script of the video can be found in the study document attached). | Other | Home management |
Primary outcome
Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric Short Form v2.0 - Physical Function Upper Extremity.
Time frame: Baseline to 6 week follow-up
This pediatric PROMIS assessment will be filled out at baseline and 6 weeks. All responses will be recorded within the study's REDCap database. Responses for each question:
4 secondary outcomes
Parent Satisfaction Survey
Time frame: Baseline to 6 week follow-up
Rigid Casting
Time frame: Baseline to 6 week follow-up
Rate of follow-up X-rays
Time frame: Baseline to 6 week follow-up
Provider time spent on delivering care
Time frame: Baseline to 6 week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Background: PubMed 9165435Landin LA. Epidemiology of children's fractures. J Pediatr Orthop B. 1997 Apr;6(2):79-83. doi: 10.1097/01202412-199704000-00002.
- Background: PubMed 22890451Bae DS, Howard AW. Distal radius fractures: what is the evidence? J Pediatr Orthop. 2012 Sep;32 Suppl 2:S128-30. doi: 10.1097/BPO.0b013e31824b2545.
- Background: PubMed 29326858Baig MN, Egan C. Improving Management of Paediatric Buckle Fracture in Orthopaedic Outpatients: A Completed Audit Loop. Cureus. 2017 Nov 8;9(11):e1829. doi: 10.7759/cureus.1829.
- Background: PubMed 25382996Koelink E, Boutis K. Paediatrician office follow-up of common minor fractures. Paediatr Child Health. 2014 Oct;19(8):407-12. doi: 10.1093/pch/19.8.407.
- Background: PubMed 11380131Symons S, Rowsell M, Bhowal B, Dias JJ. Hospital versus home management of children with buckle fractures of the distal radius. A prospective, randomised trial. J Bone Joint Surg Br. 2001 May;83(4):556-60. doi: 10.1302/0301-620x.83b4.11211.
- Background: PubMed 19577205Firmin F, Crouch R. Splinting versus casting of "torus" fractures to the distal radius in the paediatric patient presenting at the emergency department (ED): a literature review. Int Emerg Nurs. 2009 Jul;17(3):173-8. doi: 10.1016/j.ienj.2009.03.006. Epub 2009 May 7.
- Background: PubMed 20145510Boutis K. Common pediatric fractures treated with minimal intervention. Pediatr Emerg Care. 2010 Feb;26(2):152-7; quiz 158-62. doi: 10.1097/PEC.0b013e3181ce310c.
- Background: PubMed 26729537Koelink E, Schuh S, Howard A, Stimec J, Barra L, Boutis K. Primary Care Physician Follow-up of Distal Radius Buckle Fractures. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-2262. Epub 2015 Dec 10.
- Background: PubMed 16510648Plint AC, Perry JJ, Correll R, Gaboury I, Lawton L. A randomized, controlled trial of removable splinting versus casting for wrist buckle fractures in children. Pediatrics. 2006 Mar;117(3):691-7. doi: 10.1542/peds.2005-0801.
- Background: PubMed 11764434Davidson JS, Brown DJ, Barnes SN, Bruce CE. Simple treatment for torus fractures of the distal radius. J Bone Joint Surg Br. 2001 Nov;83(8):1173-5. doi: 10.1302/0301-620x.83b8.11451.
- Background: PubMed 32742213Williams BA, Palumbo NE, Phillips SA, Blakemore LC. What They Want - Caregiver and Patient Immobilization Preferences for Pediatric Buckle Fractures of the Wrist. Iowa Orthop J. 2020;40(1):83-90.
- Background: PubMed 18678461Heikkinen K, Helena LK, Taina N, Anne K, Sanna S. A comparison of two educational interventions for the cognitive empowerment of ambulatory orthopaedic surgery patients. Patient Educ Couns. 2008 Nov;73(2):272-9. doi: 10.1016/j.pec.2008.06.015.
- Individual participant dataSharing planned: No
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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.
Peter J Apel, MD, PhD principal investigator
Carilion Clinic Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational videos in people with Buckle Fracture and Patient Satisfaction, run by Carilion Clinic 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 5 inclusion and 7 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 9 Oct 2024. 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?
Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric Short Form v2.0 - Physical Function Upper Extremity. (time frame: Baseline to 6 week follow-up). 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 NCT06633094, which also lists 17 linked publications.
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 9 Oct 2024.