- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07480798
Rock-Paper-Scissors-OK in Nerve Examination
Rock-Paper-Scissors-OK Game for Neurological Examination in Pediatric Supracondylar Humerus Fractures: A Prospective Randomized Controlled Trial
Patients presenting to the Orthopedics and Traumatology Clinic of Ankara Bilkent City Hospital with supracondylar humerus (elbow) fractures will initially undergo closed reduction. Following the reduction procedure, radiographic imaging will be obtained and patients will be re-evaluated. If surgical intervention is deemed necessary based on this assessment, operative treatment will be recommended.
The surgical technique will consist of closed reduction followed by percutaneous Kirschner wire (K-wire) fixation. In cases where adequate fracture reduction cannot be achieved by closed means, open reduction will be performed through an anterior incision. In these patients, K-wires will again be inserted percutaneously.
Fixation will be achieved using one medial (ulnar side) and two lateral K-wires. Postoperatively, a neurological examination will be performed. In patients who are shown a video and taught the game beforehand, neurological assessment will be conducted using the "rock-paper-scissors" game. In other patients, the examination will be performed by demonstrating and requesting specific hand movements.
If ulnar nerve deficit is detected during postoperative neurological evaluation, the medial K-wire will be removed. The time interval between the patient's emergence from anesthesia and the neurological examination will be recorded.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
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Ankara, Ankara, Turkey (Türkiye)
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 4 to 10 years
- Underwent surgical treatment for supracondylar humerus fracture
- Willing to participate (assent/parental consent as applicable)
Exclusion Criteria:
- Cognitive inability to understand or perform the rock-paper-scissors-OK movements
- Declined participation (patient and/or parent/guardian refusal, as applicable)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Smartphone-Assisted Neurological Examination
Participants undergo neurological examination using a smartphone-assisted application (preoperatively and postoperatively).
Examination duration and patient satisfaction are recorded.
|
Participants in the smartphone-assisted group viewed a single standardized preoperative video-based training module delivered via YouTube (duration: 2 minutes 34 seconds).
|
|
Other: Conventional Neurological Examination
Participants undergo neurological examination using conventional bedside clinical assessment methods (preoperatively and postoperatively).
Examination duration and patient satisfaction are recorded.
|
Standard neurological examination performed by the clinician using conventional bedside assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative neurological examination duration (minutes)
Time Frame: Immediately postoperatively after awakening in the recovery room
|
Time required to complete the neurological examination postoperatively, recorded in minutes.
|
Immediately postoperatively after awakening in the recovery room
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative neurological deficit (yes/no)
Time Frame: Preoperatively in the emergency department (before surgery)
|
Presence of neurological deficit on examination (radial, ulnar, median, and anterior interosseous nerve function).
Recorded as yes/no (frequency, %).
|
Preoperatively in the emergency department (before surgery)
|
|
Preoperative neurological examination duration (minutes)
Time Frame: Preoperatively in the emergency department (before surgery)
|
Time required to complete the neurological examination preoperatively, recorded in minutes.
|
Preoperatively in the emergency department (before surgery)
|
|
Patient/parent satisfaction: Child Hospital Consumer Assessment of Healthcare Providers and Systems (Child HCAHPS)
Time Frame: On the day the patients is discharged after surgery (typically the 2nd or 3rd day after the operation)
|
Satisfaction was measured with the Child Hospital Consumer Assessment of Healthcare Providers and Systems (Child HCAHPS).
Domain scores were calculated as mean values on a 1-4 Likert scale (min=1, max=4); higher scores indicate better satisfaction/better care experience.
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On the day the patients is discharged after surgery (typically the 2nd or 3rd day after the operation)
|
|
Postoperative neurological deficit (yes/no)
Time Frame: Immediately postoperatively after awakening in the recovery room
|
Presence of neurological deficit on examination (radial, ulnar, median, and anterior interosseous nerve function).
Recorded as yes/no (frequency, %).
|
Immediately postoperatively after awakening in the recovery room
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Toomey SL, Zaslavsky AM, Elliott MN, Gallagher PM, Fowler FJ Jr, Klein DJ, Shulman S, Ratner J, McGovern C, LeBlanc JL, Schuster MA. The Development of a Pediatric Inpatient Experience of Care Measure: Child HCAHPS. Pediatrics. 2015 Aug;136(2):360-9. doi: 10.1542/peds.2015-0966. Epub 2015 Jul 20.
- Spinner M. The anterior interosseous-nerve syndrome, with special attention to its variations. J Bone Joint Surg Am. 1970 Jan;52(1):84-94. No abstract available.
- Davidson AW. Rock-paper-scissors. Injury. 2003 Jan;34(1):61-3. doi: 10.1016/s0020-1383(02)00102-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TABED 1-24-83; 13 March 2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Supracondylar Humerus Fractures
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