The Comparison Of Effectiveness Sensory Motor With Neurofeedback Training Effectiveness On Pain, Balance, Proprioception, and Index Valgus Dynamic Knee in Male With Patellofemoral Pain Syndrome
The Comparison Effectiveness of Sensory Motor With Neurofeedback Training Effectiveness on Pain, Balance, Proprioception, And Index Valgus Dynamic Knee In Male With Patellofemoral Pain Syndrome
Design
The Present Study Involving 45 Men With Patellofemoral Pain Syndrome. The Groups Assigned to This Study Were Randomized By Random Number Generator Software And Then Divided Into Three Groups Based on SNOSE Allocation Hiding. All Tests Will Be Performed In Sports Rehabilitation Laboratory By The Responsible And Staff of Laboratory. Then Each Intervention Will Be Performed For 8 Weeks And Three Times a Week.
Settings and conduct
All Tests And Exercises Will Be Performed In The Sports Rehabilitation Laboratory By Responsibleand Staff of The Laboratory, Will Not Be Aware of The Research Process.
Participants/Inclusion and exclusion criteria
Included: Reportof Pain Greater Than 3 Month Duration
Pain Located Specifically Around The Patellofemoral Articulation (3 out of 10 on a Visual Analog Scale)
Increase Knee Pain When Performing Activities: Sitting For Prolonged Time, Squatting, Kneeling, Running, Ascending And Descending Stairs, Jumping And Landing
No Previous Knee Surgery
Excluded: History of Surgery In Aany Lower Limb Joint
History of Patellar Subluxation or Meniscal Injury or Ligament Instability,
Intervention groups
The First Group of Sensory Motor Exercises Is Selected Based on The Janda Approach, Which Has Three Stages: Stage One or Static Stage, Second Stage Is The Dynamic Phase And Stage Three or Functional Stage Activities.Neurofeedback Training, Which Is Specific to The Second Group, Involving Increased Sensory Motor Wave And Decreasing Beta And Theta In The CZ Region.The Third Group, The Control Group, did Not Perform Any Rehabilitation Exercises During This Time.
Main outcome variables
Pain
General information
Reason for update
Acronym
PFPS Study
IRCT registration information
IRCT registration number:IRCT20191209045669N1
Registration date:2020-01-13, 1398/10/23
Registration timing:registered_while_recruiting
Last update:2020-01-13, 1398/10/23
Update count:0
Registration date
2020-01-13, 1398/10/23
Registrant information
Name
mohamadreza ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3254 4587
Email address
m.ahmadi01@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-20, 1398/09/29
Expected recruitment end date
2021-01-08, 1399/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison Of Effectiveness Sensory Motor With Neurofeedback Training Effectiveness On Pain, Balance, Proprioception, and Index Valgus Dynamic Knee in Male With Patellofemoral Pain Syndrome
Public title
The Comparison Of Effectiveness Sensory Motor With Neurofeedback Training Effectiveness On Pain, Balance, Proprioception, and Index Valgus Dynamic Knee in Male With Patellofemoral Pain Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Reportof Pain Greater Than 3 Month Duration
Pain Located Specifically Around The Patellofemoral Articulation (3 out of 10 on a Visual Analog Scale)
Increase Knee Pain When Performing Activities: Sitting For Prolonged Time, Squatting, Kneeling, Running, Ascending and Descending Stairs, Jumping and Landing
No Treatment Within The Previous 12 Months
No Previous Knee Surgery
No Neurological Disorders
Exclusion criteria:
History of Surgery in Any Lower Limb Joint
History of Patellar Subluxation or Meniscal Injury or Ligament Instability,
Neurological Involvement That Would Influence Gait
Knee Effusion
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The Sample Size of The Present Study Was Randomized By Random Number Generator Software and Then Divided Into Groups of Motor Sensory, Neurofeedback and Control Based on SNOSE Allocation Concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Sports Rehabilitation Laboratory Specialist in Patient Evaluation
Sports Rehabilitation and Clinical Psychology as a Therapist
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee of Ethics in Biomedical Research
The Timing of The Primary Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
The For Evaluate be Will Use Visual Analogue Scale For Pain.
Secondary outcomes
1
Description
Balance, Proprioception and Dynamic Knee Valgus Index.
Timepoint
Secondary Outcome Variables Will be Measured Before Treatment and 8 Weeks After Intervention.
Method of measurement
The For Evaluate be Will Use Biodex Instrument For Balance, Goniometer From Proprioception, Dynamic Valgus Index From Camera and Muscle Strength From Handel Dynamometer.
Intervention groups
1
Description
Intervention Group: Sensory Motor Training, Twenty Four Sessions,Each Session 1 Hour, 3 Days a Week
Category
Rehabilitation
2
Description
Intervention Group: Neurofeedback Training, Twenty Four Sessions, Each Session 30 Minute, 3 Days a Week
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After Completion of Interventions And Final Evaluation, The Data Will Be Shared Through The Articles To Provide a Comprehensive Treatment Process.
When the data will become available and for how long
The Results of This Study Will Be Available In Journals 9 Months After Publication.
To whom data/document is available
The Results of The Studies Will Be Accessible to All Individuals in The Community Without Any Restrictions
Under which criteria data/document could be used
The Documentation Provided Can Be Applicable to Many Musculoskeletal Pain Syndromes as a Comprehensive Treatment Intervention That Considers Several Factors. These Interventions Are Applicable If Prescribed And Monitored By Physicists And Neurologists.
From where data/document is obtainable
Individuals Can Refer to The Bu Ali Sina University Bookstore And Scientific Research Journals For Gaining Results.
What processes are involved for a request to access data/document