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

Sponsor

University of Jazan (Other)

Overall Status

Completed

CT.gov ID

NCT03900351

Collaborator

(none)

Enrollment

Location

Arms

2.2

Actual Duration (Months)

13.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Motor Activity Proprioceptive Disorders Balance; Distorted	Procedure: Wii fit protocol of virtual reality games Procedure: Regular exercise rehabilitation protocol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

There are two group of subjects: Group A (study group). Group B:(Control group).There are two group of subjects:Group A (study group). Group B:(Control group).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 7, 2019

Actual Primary Completion Date :

Jun 6, 2019

Actual Study Completion Date :

Jun 13, 2019

Arms and Interventions

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).	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 . Procedure: Regular exercise rehabilitation protocol 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.	Procedure: Regular exercise rehabilitation protocol It will be according to the criterion of Adams et al. (2012).

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).

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 .

Procedure: Regular exercise rehabilitation protocol

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.

Procedure: Regular exercise rehabilitation protocol

It will be according to the criterion of Adams et al. (2012).

Outcome Measures

Primary Outcome Measures

knee proprioception at 30 degrees [3 minutes]
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
knee proprioception at 45 degrees [3 minutes]
Biodex Isokinetic Dynamometer will be used to measure knee proprioception.
knee proprioception at 60 degrees [3 minutes]
Biodex Isokinetic Dynamometer will be used to measure knee proprioception

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jazan University	Gizan	Jazan	Saudi Arabia	45142

Sponsors and Collaborators

University of Jazan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed Moustafa, Principal invsetigator, University of Jazan

ClinicalTrials.gov Identifier:

NCT03900351

Other Study ID Numbers:

2387594650

First Posted:

Apr 3, 2019

Last Update Posted:

Jun 14, 2019

Last Verified:

Jun 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Somatosensory Disorders

Study Results

No Results Posted as of Jun 14, 2019