- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03900351
Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)
Study Overview
Status
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jazan
-
Gizan, Jazan, Saudi Arabia, 45142
- Jazan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients who will be in the early postoperative phase (week 2 after surgery)
- patients with BMI less than 25, and more than 20.
Exclusion Criteria:
- Patients with injury or operation accompanied by the ACLR as meniscectomy.
- Patients with any deformities affecting knee joint alignment as genu valgus, genu varus, or genu recurvatum.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Group A: Study group
They will receive the Wii fit protocol of virtual reality games for 40 minutes, 3 times per week, for 8 weeks, in addition to the regular exercise rehabilitation protocol according to the criterion of Adams et al. (2012).
|
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 .
It will be according to the criterion of Adams et al. (2012).
|
|
EXPERIMENTAL: Group B: Control group
They will receive the regular exercise rehabilitation protocol only for 40 minutes, for 3 days per week, for 8 weeks.
|
It will be according to the criterion of Adams et al. (2012).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
knee proprioception at 30 degrees
Time Frame: 3 minutes
|
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
|
3 minutes
|
|
knee proprioception at 45 degrees
Time Frame: 3 minutes
|
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
|
3 minutes
|
|
knee proprioception at 60 degrees
Time Frame: 3 minutes
|
Biodex Isokinetic Dynamometer will be used to measure knee proprioception
|
3 minutes
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2387594650
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.
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