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Virtual Reality for Tibial Eminence Fractures

Primary Purpose

Tibial Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
physical therapy
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Fractures focused on measuring Tibial eminence fracture, Virtual reality

Eligibility Criteria

5 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Valley University, Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control Group

Study Group

Arm Description

children received selected physical therapy exercises

children received selected physical therapy exercises plus virtual reality training

Outcomes

Primary Outcome Measures

Visual analogue scale
assessment severity of pain
Visual analogue scale
assessment severity of pain

Secondary Outcome Measures

A universal goniometer
assessment te range of knee extension
A universal goniometer
assessment te range of knee extension

Full Information

First Posted
January 14, 2021
Last Updated
January 21, 2021
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT04722081
Brief Title
Virtual Reality for Tibial Eminence Fractures
Official Title
Virtual Reality Training Combined With a Physical Therapy Program in the Rehabilitation of Patients After Tibial Eminence Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
Keywords
Tibial eminence fracture, Virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Experimental
Arm Description
children received selected physical therapy exercises
Arm Title
Study Group
Arm Type
Experimental
Arm Description
children received selected physical therapy exercises plus virtual reality training
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
physical therapy-specific exercises
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
assessment severity of pain
Time Frame
pain assessment at day 0
Title
Visual analogue scale
Description
assessment severity of pain
Time Frame
pain assessment at day 180
Secondary Outcome Measure Information:
Title
A universal goniometer
Description
assessment te range of knee extension
Time Frame
assessment te range of knee extension at date 0
Title
A universal goniometer
Description
assessment te range of knee extension
Time Frame
assessment te range of knee extension at date 180
Other Pre-specified Outcome Measures:
Title
Pediatric Balance Scale
Description
assessment of balance
Time Frame
assessment of balance at date 0
Title
Pediatric Balance Scale
Description
assessment of balance
Time Frame
assessment of balance at date 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira H Mohammed, Professor
Phone
01144495063
Email
amira_hussin77@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nehad A Abo-zaid, lecturer
Phone
01223265216
Email
dr.nehadahmed@svu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehad A Abo-zaid, lecturer
Organizational Affiliation
South Valley University, Faculty of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Valley University, Faculty of Physical Therapy
City
Qina,
ZIP/Postal Code
83523
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nehad A Abo-zaid, Lecturer
Phone
01223265216
Email
dr.nehadahmed@svu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21087865
Citation
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.
Results Reference
background
PubMed Identifier
19633462
Citation
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.
Results Reference
background
PubMed Identifier
20032285
Citation
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.
Results Reference
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Learn more about this trial

Virtual Reality for Tibial Eminence Fractures

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