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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03900351
Other study ID # 2387594650
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 7, 2019
Est. completion date June 13, 2019

Study information

Verified date June 2019
Source University of Jazan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Influence of virtual reality games(Wii Fit) on knee proprioception after anterior cruciate ligament reconstruction (ACLR) will be measured in 30 postoperative patients. The age of participants will be ranged from 20 to 30 years old. Subjects will be randomly assigned to Group A is the study group and Group B is the control group.


Description:

Group A will receive the Wii fit protocol of virtual reality games, in addition to the regular exercise rehabilitation protocol, for 3 non-consecutive days per week, for 8 weeks , 40 minutes for each session. Group B will receive the regular exercise rehabilitation protocol only for 3 non-consecutive days per week for 8 weeks, 40 minutes for each session.

A Universal Weight and Height Scale: will be used to measure the patient's BMI.

Biodex Isokinetic Dynamometer: will be used to assess the knee proprioception of the affected operated leg at three target angles (30,45,and 60 degrees).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 13, 2019
Est. primary completion date June 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria:

1. patients who will be in the early postoperative phase (week 2 after surgery)

2. patients with BMI less than 25, and more than 20.

Exclusion Criteria:

1. Patients with injury or operation accompanied by the ACLR as meniscectomy.

2. Patients with any deformities affecting knee joint alignment as genu valgus, genu varus, or genu recurvatum.

Study Design


Intervention

Procedure:
Wii fit protocol of virtual reality games
the Wii fit session by standing on the Wii fit board with bare feet, hands on hips and both eyes open. Pretest on Wii fit was done to make the subject familiar with the board and tasks of weight shift .
Regular exercise rehabilitation protocol
It will be according to the criterion of Adams et al. (2012).

Locations

Country Name City State
Saudi Arabia Jazan University Gizan Jazan

Sponsors (1)

Lead Sponsor Collaborator
University of Jazan

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary knee proprioception at 30 degrees Biodex Isokinetic Dynamometer will be used to measure knee proprioception. 3 minutes
Primary knee proprioception at 45 degrees Biodex Isokinetic Dynamometer will be used to measure knee proprioception. 3 minutes
Primary knee proprioception at 60 degrees Biodex Isokinetic Dynamometer will be used to measure knee proprioception 3 minutes
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