Supracondylar Humerus FractureNCT00871793
Effect of Occupational Therapy on the Function and Mobility of Elbow Fractures
A study testing Occupational therapy in people with Supracondylar Humerus Fracture, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Supracondylar humerus fracture are common upper extremity injuries in children accounting for over 400 fractures per year and approximately 25% of all fractures treated at Seattle Children's Emergency Department. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Supracondylar Humerus Fracture
- What is being tested?
- Occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2011
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a supracondylar fracture which is isolated, non - comminuted, and less than one week old.
- Will be treated with either casting or surgery.
- Lack head injuries or other fractures.
- Are not cognitively impaired or critically ill.
- Are 5 - 12 years old
- Speak English or Spanish
Who cannot join
- Requires open reduction to align
- Comminuted or t - intercondylar fracture
- Other fractures on the same limb
- Head injury
- Cognitive impairment
- Critically ill
- Mental disorders
- Fracture occurred more than one week prior to visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Effect of Occupational Therapy on the Function and Mobility in Supracondylar Humerus Fractures: A Randomized Controlled Trial
Supracondylar humerus fracture are common upper extremity injuries in children accounting for over 400 fractures per year and approximately 25% of all fractures treated at Seattle Children's Emergency Department. Most of these fractures are treated with splints and casts though more than one-third undergo surgical fixation followed by casting. Healing is usually complete after 3-4 weeks, when casts (and pins, if fixed operatively) are removed and motion begun. Though stiffness is often a problem after immobilization of adult elbow fractures, stiffness after pediatric elbow fractures is regarded as typically transient. This study addresses the question "Does early motion of the arm with physiotherapy promote the return of function and motion in patients with supracondylar humerus fractures?" The investigators will conduct a prospective randomized trial to determine the effect of six occupational therapy visits over a five week period of time on elbow function and mobility after supracondylar humerus fracture. The investigators will measure motion of the elbow and administer the child and parental Activity Scale for Kids performance versions (ASKp) assessment tool to answer this question.
- Conditions
- Supracondylar Humerus Fracture
- Being tested
- Occupational therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational therapyOther
Participants in this arm will receive six sessions of occupational therapy in a 5 week period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Occupational therapy Receives: Other: Occupational therapy |
| 2 | No intervention | watchful waiting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Scale for Kids performance version (ASKp)
Measured: week 1, week 6, week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supracondylar Humerus FractureStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Schmale, Seattle Children's Hospital
- Investigators
- Gregory Schmale, MD, Principal investigator, University of Washington - Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871793
- Sponsor's protocol ID
- AEF-24801
- Status last verified
- Jun 2012
- First submitted
- 27 Mar 2009
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Occupational Therapy on the Function and Mobility in Supracondylar Humerus Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00871793
- Acronym / sponsor ID
- AEF-24801
- Conditions
- Supracondylar Humerus Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Mar 2009 (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.
Supracondylar humerus fracture are common upper extremity injuries in children accounting for over 400 fractures per year and approximately 25% of all fractures treated at Seattle Children's Emergency Department. Most of these fractures are treated with splints and casts though more than one-third undergo surgical fixation followed by casting. Healing is usually complete after 3-4 weeks, when casts (and pins, if fixed operatively) are removed and motion begun. Though stiffness is often a problem after immobilization of adult elbow fractures, stiffness after pediatric elbow fractures is regarded as typically transient. This study addresses the question "Does early motion of the arm with physiotherapy promote the return of function and motion in patients with supracondylar humerus fractures?" The investigators will conduct a prospective randomized trial to determine the effect of six occupational therapy visits over a five week period of time on elbow function and mobility after supracondylar humerus fracture. The investigators will measure motion of the elbow and administer the child and parental Activity Scale for Kids performance versions (ASKp) assessment tool to answer this question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Occupational therapyOccupational therapy |
| 2 | No intervention | –watchful waiting |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Have a supracondylar fracture which is isolated, non - comminuted, and less than one week old.
- Will be treated with either casting or surgery.
- Lack head injuries or other fractures.
- Are not cognitively impaired or critically ill.
- Are 5 - 12 years old
Key exclusion criteria (8 listed)
- Requires open reduction to align
- Comminuted or t - intercondylar fracture
- Other fractures on the same limb
- Head injury
- Cognitive impairment
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 |
|---|---|---|
| Occupational therapyParticipants in this arm will receive six sessions of occupational therapy in a 5 week period. | Other | 1 |
Primary outcome
Activity Scale for Kids performance version (ASKp)
Time frame: week 1, week 6, week 12, week 24
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 2 Jul 2012.
Related trials for Supracondylar Humerus Fracture
Enrolling by invitation
Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial
Supracondylar Humerus Fracture, Anxiety
Not yet recruiting
Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Which One ?
Humeral Fractures
RecruitingObservational study
EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study
Elbow Fractures, Distal Humerus Fracture
RecruitingPhase 4
Supracondylar Post-Operative Pain Study
Supracondylar Humerus Fracture
Not yet recruiting
Management of Vascular Complications in Pediatric Supracondylar Humerus Fractures
Vascular Complications, Supracondylar Humerus Fracture
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.
Gregory Schmale, MD principal investigator
University of Washington - Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational therapy in people with Supracondylar Humerus Fracture, run by Seattle Children's Hospital 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 8 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 2 Jul 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?
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?
Activity Scale for Kids performance version (ASKp) (time frame: week 1, week 6, week 12, week 24). 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 2 Jul 2012.