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Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)

Primary Purpose

Motor Activity, Proprioceptive Disorders, Balance; Distorted

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Wii fit protocol of virtual reality games
Regular exercise rehabilitation protocol
Sponsored by
University of Jazan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motor Activity

Eligibility Criteria

20 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Jazan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A: Study group

Group B: Control group

Arm Description

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).

They will receive the regular exercise rehabilitation protocol only for 40 minutes, for 3 days per week, for 8 weeks.

Outcomes

Primary Outcome Measures

knee proprioception at 30 degrees
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
knee proprioception at 45 degrees
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
knee proprioception at 60 degrees
Biodex Isokinetic Dynamometer will be used to measure knee proprioception

Secondary Outcome Measures

Full Information

First Posted
April 1, 2019
Last Updated
June 13, 2019
Sponsor
University of Jazan
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1. Study Identification

Unique Protocol Identification Number
NCT03900351
Brief Title
Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)
Official Title
Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 7, 2019 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 13, 2019 (Actual)

3. Sponsor/Collaborators

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

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
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Activity, Proprioceptive Disorders, Balance; Distorted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two group of subjects: Group A (study group). Group B:(Control group).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Study group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Group B: Control group
Arm Type
Experimental
Arm Description
They will receive the regular exercise rehabilitation protocol only for 40 minutes, for 3 days per week, for 8 weeks.
Intervention Type
Procedure
Intervention Name(s)
Wii fit protocol of virtual reality games
Intervention Description
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 .
Intervention Type
Procedure
Intervention Name(s)
Regular exercise rehabilitation protocol
Intervention Description
It will be according to the criterion of Adams et al. (2012).
Primary Outcome Measure Information:
Title
knee proprioception at 30 degrees
Description
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
Time Frame
3 minutes
Title
knee proprioception at 45 degrees
Description
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
Time Frame
3 minutes
Title
knee proprioception at 60 degrees
Description
Biodex Isokinetic Dynamometer will be used to measure knee proprioception
Time Frame
3 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Jazan University
City
Gizan
State/Province
Jazan
ZIP/Postal Code
45142
Country
Saudi Arabia

12. IPD Sharing Statement

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Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)

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