- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04722081
Virtual Reality for Tibial Eminence Fractures
January 21, 2021 updated by: Nehad Ahmed Youness Abo-zaid, South Valley University
Virtual Reality Training Combined With a Physical Therapy Program in the Rehabilitation of Patients After Tibial Eminence Fractures
Tibial eminence fracture, a bony avulsion of the anterior cruciate ligament (ACL) from its insertion on the intercondylar eminence,1 was first described by Poncet in 1875. 2 Also known as tibial spine fractures, these injuries occur most commonly in skeletally immature patients between the ages of 8 and 14 years
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amira H Mohammed, Professor
- Phone Number: 01144495063
- Email: amira_hussin77@yahoo.com
Study Locations
-
-
-
Qina,, Egypt, 83523
- Recruiting
- South Valley University, Faculty of Physical Therapy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 9 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age of children from five to nine
- children have fracture in tibial eminence
Exclusion Criteria:
- children have fracture in tibial eminence grade III
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Control Group
children received selected physical therapy exercises
|
physical therapy-specific exercises
|
EXPERIMENTAL: Study Group
children received selected physical therapy exercises plus virtual reality training
|
physical therapy-specific exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale
Time Frame: pain assessment at day 0
|
assessment severity of pain
|
pain assessment at day 0
|
Visual analogue scale
Time Frame: pain assessment at day 180
|
assessment severity of pain
|
pain assessment at day 180
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A universal goniometer
Time Frame: assessment te range of knee extension at date 0
|
assessment te range of knee extension
|
assessment te range of knee extension at date 0
|
A universal goniometer
Time Frame: assessment te range of knee extension at date 180
|
assessment te range of knee extension
|
assessment te range of knee extension at date 180
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Balance Scale
Time Frame: assessment of balance at date 0
|
assessment of balance
|
assessment of balance at date 0
|
Pediatric Balance Scale
Time Frame: assessment of balance at date 180
|
assessment of balance
|
assessment of balance at date 180
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Young W, Ferguson S, Brault S, Craig C. Assessing and training standing balance in older adults: a novel approach using the 'Nintendo Wii' Balance Board. Gait Posture. 2011 Feb;33(2):303-5. doi: 10.1016/j.gaitpost.2010.10.089. Epub 2010 Nov 18.
- Wilfinger C, Castellani C, Raith J, Pilhatsch A, Hollwarth ME, Weinberg AM. Nonoperative treatment of tibial spine fractures in children-38 patients with a minimum follow-up of 1 year. J Orthop Trauma. 2009 Aug;23(7):519-24. doi: 10.1097/BOT.0b013e3181a13fe4.
- Vander Have KL, Ganley TJ, Kocher MS, Price CT, Herrera-Soto JA. Arthrofibrosis after surgical fixation of tibial eminence fractures in children and adolescents. Am J Sports Med. 2010 Feb;38(2):298-301. doi: 10.1177/0363546509348001. Epub 2009 Dec 23.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2015
Primary Completion (ANTICIPATED)
February 1, 2021
Study Completion (ANTICIPATED)
March 1, 2021
Study Registration Dates
First Submitted
January 14, 2021
First Submitted That Met QC Criteria
January 21, 2021
First Posted (ACTUAL)
January 25, 2021
Study Record Updates
Last Update Posted (ACTUAL)
January 25, 2021
Last Update Submitted That Met QC Criteria
January 21, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIBIAL EMINENCE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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