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IRCT20090831002391N40 IRCT 2019-10-23 Shiraz University of Medical Sciences The effects of training program with virtual reality on women with patellofemoral pain The effects of training program with virtual reality system on clinical indices and brain mapping of women with patellofemoral pain: A Randomized Clinical Trial study 2020-03-20 anticipated 26 Complete https://irct.ir/trial/43087 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: All participants are invited to study through advertisements. According to related past studies the sample size estimated 22 subjects (11 subjects per groups) and with considering the 20% attrition with ratio of 1:1 (intervention group:control group) for each of group at least 13 subjects were considered. Assignment of people to groups will be based on the Block Balanced Randomization (BBR) method. After one month from the end of the study, follow up will be performed in both study groups just on clinical indicators, Randomization description: Assignment of patients in two groups of intervention and control was done by Block Balanced Randomization (BBR) method. The Randomization Sequence is generated with using the free web site at http://www.randomization.com. Non-transparent and sealed envelopes will be used to conceal the assignment of individuals to groups, Blinding description: The assessor will not be aware of which intervention will be administered to which subject. The data analyzer also does not know the groups (control or intervention). 2 Patellofemoral pain. Intervention 1: Intervention group: The intervention group will receive training with XBOX Kinect 360 for 8 weeks in addition to the training provided to the control group. The intervention group will be trained 3 times a week.The games used in this study are from the three packages of Kinect adventures, Kinect Sport and Your Shape Fitness Evolved 2012. The intensity of the games will vary from easy to hard depending on each patient's ability and progress. Each training session lasts about 40 minutes, with each person warm up to 5 minutes before starting the game, and 5 minutes cool down after the game, and practicing XBOX for 30 minutes. All training sessions will be conducted under the supervision of a physiotherapist. Intervention 2: Control group: During the 8 weeks, the control group will continue their daily routine and no intervention will be performed in this group, only training necessary to manage their daily activities (to prevent the development of patellofemoral pain) will be given. educations are provided to people with a prepared text that includes information on how to sit properly, manage of use the stair, proper footwear, no prolonged exposure to a particular situation, use of toilets, etc. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The standard data will be prepared and will be sent to the journal if needed.
public Naghmeh Ebrahimi
School of Rehabilitation, Abiverdi street, Chamran blvd
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3626 1081 n_ebrahimi@sums.ac.ir Shiraz University of Medical Sciences scientific Zahra Rojhani Shirazi
School of Rehabilitation, Abiverdi 1 street, Chamran blvd
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3626 1081 rojhaniz@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Women between the ages of 18-40 years Anterior knee pain (in the back or around the patella) for at least 6 months Pain in the retropatellar area and around the knee in at least 2 of the following activities: prolonged sitting with bent knees, climbing stairs, squatting, running, kneeling, hopping / jumping Having symptoms in 2 of clinical tests: pain during patellar apprehension test, pain and crepitation during patellar compression test(in fact positive patellofemoral grinding test) Onset of pain without a history of trauma Pain in touch of the facet of patella 3 or more pain based on Visual Analogues Scale(VAS) while step up and down from a 25cm step or on squatting No pain above 7 on the VAS scale Lack of visual and neurological problems Right dominance Bilateral knee involvement Kujala questionnaire score less than 83 No use of drugs that affect balance in the past 72 hours 18 years 40 years Female Knee osteoarthritis History of knee surgery History of patellar dislocation Laxity of ligament Patellar tendon or cartilage pathology Referred pain from lumbar spine Other abnormalities such as leg length discrepancy(more than 2 centimeter) Physiotherapy or acupuncture in the past three months History of epilepsy or cardiovascular disease Pregnancy Diabetes Rheumatic diseases Professional athlete M22.40 Chondromalacia patellae, unspecified knee Treatment - Other Other Intervention group: The intervention group will receive training with XBOX Kinect 360 for 8 weeks in addition to the training provided to the control group. The intervention group will be trained 3 times a week.The games used in this study are from the three packages of Kinect adventures, Kinect Sport and Your Shape Fitness Evolved 2012. The intensity of the games will vary from easy to hard depending on each patient's ability and progress. Each training session lasts about 40 minutes, with each person warm up to 5 minutes before starting the game, and 5 minutes cool down after the game, and practicing XBOX for 30 minutes. All training sessions will be conducted under the supervision of a physiotherapist. Control group: During the 8 weeks, the control group will continue their daily routine and no intervention will be performed in this group, only training necessary to manage their daily activities (to prevent the development of patellofemoral pain) will be given. educations are provided to people with a prepared text that includes information on how to sit properly, manage of use the stair, proper footwear, no prolonged exposure to a particular situation, use of toilets, etc. Balance. Timepoint: Before intervention and immediately after completion 8 weeks interventionقبل. Method of measurement: Modified Star Excursion Balance Test(SEBT). Quality of life. Timepoint: Before intervention and immediately after completion 8 weeks intervention. Method of measurement: SF-36 (Short Form Health Survey)questionnaire. Function. Timepoint: Before intervention and immediately after completion 8 weeks intervention. Method of measurement: Step down test and Kujala Patellofemoral Scale. Brain mapping. Timepoint: Before intervention and immediately after completion 8 weeks intervention. Method of measurement: Quantitative Electroencephalography(QEEG). Pain. Timepoint: Before intervention and immediately after completion 8 weeks intervention. Method of measurement: Visual Analogue Scale. Vice chancellor for research, Shiraz University of Medical Sciences Approved 2019-09-18 Ethics committee of research in Shiraz University of Medical Science Central building of Shiraz University of Medical Science, Zand Ave Shiraz Fars Iran (Islamic Republic of)