Tibial FracturesNCT04722081
Virtual Reality for Tibial Eminence Fractures
A study testing physical therapy in people with Tibial Fractures, run by South Valley University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2015to 1 Mar 2021
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age of children from five to nine
- children have fracture in tibial eminence
Who cannot join
- children have fracture in tibial eminence grade III
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Valley University, Faculty of Physical Therapy
Qina, 83523
Nehad A Abo-zaid, Lecturer, 01223265216, dr.nehadahmed@svu.edu.eg
About this study
Official title: 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
- Conditions
- Tibial Fractures
- Being tested
- physical therapy
- Keywords
- Tibial eminence fracture, Virtual reality
- Medical subject headings
- Tibial Fractures, Knee Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyOther
physical therapy-specific exercises
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | children received selected physical therapy exercises Receives: Other: physical therapy |
| Study Group | Experimental | children received selected physical therapy exercises plus virtual reality training Receives: Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
assessment severity of pain
Measured: pain assessment at day 0
Visual analogue scale
assessment severity of pain
Measured: pain assessment at day 180
Secondary outcomes (2)
A universal goniometer
assessment te range of knee extension
Measured: assessment te range of knee extension at date 0
A universal goniometer
assessment te range of knee extension
Measured: assessment te range of knee extension at date 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Jan 2015
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tibial FracturesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehad Ahmed Youness Abo-zaid, South Valley University
- Investigators
- Nehad A Abo-zaid, lecturer, Principal investigator, South Valley University, Faculty of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722081
- Sponsor's protocol ID
- TIBIAL EMINENCE
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21087865Wilfinger 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.
PubMed 19633462Vander 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.
PubMed 20032285
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Training Combined With a Physical Therapy Program in the Rehabilitation of Patients After Tibial Eminence Fractures
- ClinicalTrials.gov ID
- NCT04722081
- Acronym / sponsor ID
- TIBIAL EMINENCE
- Conditions
- Tibial Fractures
- Keywords
- Tibial eminence fracture, Virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 25 Jan 2021 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: physical therapychildren received selected physical therapy exercises |
| Study Group | Experimental | Other: physical therapychildren received selected physical therapy exercises plus virtual reality training |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age of children from five to nine
- children have fracture in tibial eminence
Key exclusion criteria (1 listed)
- children have fracture in tibial eminence grade III
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 |
|---|---|---|
| physical therapyphysical therapy-specific exercises | Other | Control Group, Study Group |
Primary outcome
Visual analogue scale
Time frame: pain assessment at day 0
assessment severity of pain
Visual analogue scale
Time frame: pain assessment at day 180
assessment severity of pain
2 secondary outcomes
A universal goniometer
Time frame: assessment te range of knee extension at date 0
A universal goniometer
Time frame: assessment te range of knee extension at date 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Background: PubMed 21087865Young 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.
- Background: PubMed 19633462Wilfinger 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.
- Background: PubMed 20032285Vander 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.
- 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.
Nehad A Abo-zaid, lecturer principal investigator
South Valley University, Faculty of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy in people with Tibial Fractures, run by South Valley University at 1 site in Egypt.
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 1 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 25 Jan 2021. 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 Egypt. 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?
Contact Amira H Mohammed, Professor (01144495063, amira_hussin77@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: pain assessment at day 0). The study lists 2 primary outcomes in all. 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 NCT04722081, which also lists 3 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 25 Jan 2021.