The effect of proximal and distal exercises along with movement pattern retraining on kinematic and kinetic variables of patients with patellofemoral pain
The Effect of Proximal and Distal Exercises Along with Movement Pattern Retraining on Kinematic and Kinetic Variables of Patients With Patellofemoral Pain
Design
Clinical trial with a control group, with parallel groups, single blind, randomized, phase 2 on 45 patients. Random Number Generator software will be used for randomization.
Settings and conduct
All tests and exercises in sports rehabilitation laboratory Bu Ali Sina University Hamedan will be performed by laboratory's official and experts, who will not be aware research process. groups will be divided in such a way that first group includes resistance exercises with proximal movement pattern retraining, second group includes resistance exercises with distal movement pattern retraining, third group will not receive any rehabilitation exercises during this period. It should be noted that evaluators will not know the purpose study and allocation groups, so our study will be one-sided blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. 20 to 60 years
2. Pain in the anterior and posterior part of the patella
3. Pain intensity 3 out of 10 on visual analog scale
4. Dynamic Valgus angle of more than 10 degrees
5. The positiveness of the step down test and Clark
Exclusion criteria:
1. Having a history of injury in the last year in the lower limb area
Intervention groups
Proximal strengthening exercises with motor retraining are specific to the first group and distal strengthening exercises with motor retraining are specific to the second group. The third group, which is the control group, will not perform any rehabilitation exercises during this period.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230425057991N1
Registration date:2023-06-08, 1402/03/18
Registration timing:registered_while_recruiting
Last update:2023-06-08, 1402/03/18
Update count:0
Registration date
2023-06-08, 1402/03/18
Registrant information
Name
Fatemeh Ahadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4240 4019
Email address
f.ahadi@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of proximal and distal exercises along with movement pattern retraining on kinematic and kinetic variables of patients with patellofemoral pain
Public title
Investigating the effect of resistance training along with movement pattern retraining in femoral patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 60 years
Pain in the anterior and posterior part of the patella for more than 6 weeks
Pain intensity 3 out of 10 on the visual analog scale
Dynamic valgus angle of more than 10 degrees
The positiveness of the stairs descent test and Clark
No injuries in the hip and ankle joints
No history of surgery or neurological disease
Not having a history of participating in physical therapy in the past years
Exclusion criteria:
Deformity of Upper and Lower Limbs
History of Surgery or Neurological Disease
Injuries Other Than Patellofemoral Pain
Knee Joint Instability
Use of Painkillers
Participation in Physiotherapy Sessions
Participation in Sports Activities
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
We used Random Allocation Software for randomization. Random codes were generated in blocks 4 and 6. We used sequentially numbered sealed opaque envelopes to conceal the allocation. The third researcher, who had no role in data collection and was not aware of the study process, opened the envelopes containing the random codes and handed them to the patients. As a result, patients were randomly assigned to experimental and control groups with a rate of 1:1.
Blinding (investigator's opinion)
Single blinded
Blinding description
The second researcher who was not involved in the data collection, opened the envelopes containing random codes and delivers to the subjects. The laboratory technicians were not aware of the purpose of the present study and the groups allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee in Biomedical Research
Street address
No. 12, Motahari St. 5, Shkoufeh Alley
City
Saveh
Province
Markazi
Postal code
3914658335
Approval date
2023-04-11, 1402/01/22
Ethics committee reference number
IR.BASU.REC.1402.012
Health conditions studied
1
Description of health condition studied
Patellofemoral Pain
ICD-10 code
M99.06
ICD-10 code description
Segmental and somatic dysfunction of lower extremity
Primary outcomes
1
Description
Pain
Timepoint
The Timing of The 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
Dynamic Knee Valgus
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
A Camera Will be Used to Evaluate the Dynamic Knee Valgus.
2
Description
Strength of Hip Abductor Muscles
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
A Manual Dynamometer will be Used to Evaluate the Strength of Hip Abductor Muscles.
3
Description
Plantar Pressure Distribution
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
A Foot Pressure Device Will be Used to Evaluate The Plantar Pressure Distribution.
4
Description
Pain Catastrophic
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
Catastrophic Questionnaire Will be Used to Evaluate Catastrophic.
5
Description
Static and Dynamic Balance
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
Biodex Device Will be Used to Evaluate Static and Dynamic Balance.
6
Description
Knee Flexion
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
A Camera Will be Used to Evaluate the Knee Flexion.
7
Description
Pelvic Drop
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
A Camera Will be Used to Evaluate the Pelvic Drop.
8
Description
Rear-Foot Eversion
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
A Camera Will be Used to Evaluate the Rear-Foot Eversion.
9
Description
Dorsiflexion
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
A Camera Will be Used to Evaluate the Dorsiflexion.
10
Description
Strength of Hip External Rotators Muscles
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
A Manual Dynamometer will be Used to Evaluate the Strength of Hip External Rotators Muscles.
11
Description
Strength of Hip Extensors Muscles
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
A Manual Dynamometer will be Used to Evaluate the Strength of Hip Extensors Muscles.
12
Description
Strength of Ankle Dorsiflexors Muscles
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
A Manual Dynamometer will be Used to Evaluate the Strength of Ankle Dorsiflexors Muscles.
13
Description
Strength of Foot Invertors Muscles
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
A Manual Dynamometer will be Used to Evaluate the Strength of Foot Invertors Muscles.
14
Description
Kinesiophobia
Timepoint
The Timing of The Outcome Measure Will be Performed Before The Intervention and 8 Weeks After The Intervention.
Method of measurement
Tampa Questionnaire Will be Used to Evaluate Kinesiophobia.
Intervention groups
1
Description
The first intervention group: Resistance training of the thigh muscles will be done in eight weeks, three sessions a week and each session will last about 60 minutes with the presence of 50 people and under the supervision of the researcher. Training sessions will include about 10 minutes of general warm-up, 40 minutes of mentioned resistance exercises and movement retraining, and 10 minutes of cooling down in the form of stretching exercises. The resistance training program is based on the Fukuda 2010 training program and the motor retraining training program is based on the B Noehren training program.
Category
Rehabilitation
2
Description
The second intervention group: Resistance exercises for the ankle muscles will be performed in eight weeks, three sessions a week and each session will last about 60 minutes with the presence of 50 people and under the supervision of the researcher. Training sessions will include about 10 minutes of general warm-up, 40 minutes of mentioned resistance exercises and movement retraining, and 10 minutes of cooling down in the form of stretching exercises. The resistance training program is based on the training program of Carsten M. Mølgaard 2017 and the motor retraining training program is based on the training program of Roper 2016.
Category
Rehabilitation
3
Description
Control group: No Intervention
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic Clinics of Hamadan Province
Full name of responsible person
Fatemeh Ahadi
Street address
No. 12, Motahari St. 5, Shkoufeh Alley
City
Saveh
Province
Markazi
Postal code
3914658335
Phone
+98 918 431 4958
Email
f.ahadi@phe.basu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu ali Sina University, Hamedan
Full name of responsible person
Dr. Ali Yalfani
Street address
No. 12, Motahari St. 5, Shkoufeh Alley
City
Saveh
Province
Markazi
Postal code
3914658335
Phone
+98 918 431 4958
Email
f.ahadi@phe.basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
There is no source of financial support.
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
دانشگاه بوعلی سینا همدان
Full name of responsible person
Dr. Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Hamedan, Shahid Mostafa Ahmadi Roshan Blvd., Bu Ali Sina University, Faculty of Physical Education and Sports Sciences
City
Hamedan
Province
Hamadan
Postal code
3914658335
Phone
+98 81 3838 1421
Email
ali_yalfani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Buali Sina University, Hamedan
Full name of responsible person
Dr. Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Hamedan, Shahid Mostafa Ahmadi Roshan Blvd., Bu Ali Sina University, Faculty of Physical Education and Sports Sciences
City
Saveh
Province
Hamadan
Postal code
3914658335
Phone
+98 81 3838 1421
Email
ali_yalfani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Fatemeh Ahadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Hamedan, Shahid Mostafa Ahmadi Roshan Blvd., Bu Ali Sina University, Faculty of Physical Education and Sports Sciences
City
Saveh
Province
Markazi
Postal code
3914658335
Phone
+98 86 4240 4019
Email
f.ahadi@phe.basu.ac.ir
Sharing plan
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
All data and documents can be shared, but with the non-identification of people and the preservation of private information of subjects
When the data will become available and for how long
The Results of This Study Will Be Available In Journals 3
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 presented documentation can be used for the treatment of patellofemoral pain. These interventions are applicable if they are prescribed and supervised by a physiotherapist.
From where data/document is obtainable
E-mail Fatemeh Ahadi
f.ahadi@phe.basu.ac.ir
What processes are involved for a request to access data/document
When the applicant provides documents for her field of work related to the subject of the thesis and in case of a reasonable request and a commitment not to misuse the data of this research, the data will be sent to her for 1 working week.