Protocol summary

Study aim
Are adding eccentric exercises to gait retraining exercises have any effect on pain, kinetics and kinematics during running in patients with patellofemoral pain?
Design
Clinical trial that including control group, parallel groups, single blinded, randomized, 3 groups on 30 patients, The site /http://randomizer.org is used for randomization.
Settings and conduct
The effect of adding eccentric exercises to gait retraining exercises on runners with patellofemoral pain. The kinetics and kinematics parameters are performed before and after 8 weeks of intervention in the biomechanical laboratory of Kharzami University. Participants and Analyzer are unaware of how the allocation and results are.
Participants/Inclusion and exclusion criteria
inclusions: Male and female runners with 3 years continuous history of recreational sports; 18 to 40 years old age group, 20 and 25 body mass index patients have a patellofemoral pain syndrome with a history of 2 months and intensity of 3 to 7 on the visual analog scale. exclusions: history of lower and torso injury in the past year, lower limb abnormalities, surgery in the lower limbs, especially the knee, before participating.
Intervention groups
The retraining group includes patients that have patellofemoral pain and receive gait retraining with using verbal feedback. the eccentric exercises Group includes patients who receive eccentric exercises in addition to gait retraining. the control group includes patients who do not receive any intervention. both groups participate 3 sessions each week for 8 weeks with the presence of the researcher. each session take 90 minutes includes warm up, exercise and cooling down. eccentric exercises are based on previous studies of patellofemoral pain.
Main outcome variables
Pain, ground reaction force, pelvic drop, hip adduction, knee flexion, knee valgus and dorsiflexion.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220812055662N1
Registration date: 2022-09-29, 1401/07/07
Registration timing: prospective

Last update: 2022-09-29, 1401/07/07
Update count: 0
Registration date
2022-09-29, 1401/07/07
Registrant information
Name
Elahe Omidvar
Name of organization / entity
The University of kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 4983
Email address
elahe.omidvar@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-08, 1401/07/16
Expected recruitment end date
2022-12-03, 1401/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding eccentric exercises to gait retraining exercises on pain, kinetics and kinematics of runners with patellofemoral pain syndrome
Public title
The effect of eccentric exercises with gait retraining on reducing patellofemoral pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female runners with a continuous history of recreational sports in the last 3 years 18 to 40 years age group Standard Body Mass Index between 20 –25 Patellofemoral pain syndrome with a history of 2 months and a intensity of 3 to 7 on a visual analog scale
Exclusion criteria:
History of lower and upper body damage in the past year Lower body zone abnormalities Surgery history in the lower limbs, especially the knee, before participating in the study
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
After initial review, using the http://randomizer.org/ website, patients who have criteria for entering the study randomly participate in retraining، eccentric exercises and control groups. randomization will be simple type. hiding the random allocation using computer-generated randomized block table ( number 1 for retraining group, number 2 for eccentric exercises group and number 3 for control group ). The random numerical sequence is placed in non-transparent and sealed envelopes and will be opened by a third party and the treatment process will continue in accordance with the group's assignment. the evaluator will evaluate the results before the intervention and after 8 weeks of intervention, independent of the hypothesis and methods of the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants read the consent form and present in a 30-minute session of the study groups then participate in this study with satisfaction, without the authority to select their group. the names of the patients are informed by a person unaware of the identity characteristics and Physically, patients randomly divided into three equal groups by / http://randomizer.org and each group is placed separately in sealed envelopes. Each person receive own training and exercises according to their assigned group. the analyzer also examines and compares changes made before and after 8 weeks without knowing the hypotheses, study methods, and patient specifications.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of sport sciences Research Institute
Street address
No. 45, Payande 5 Ave., Mosala 18 Blvd.,Rastgar St.
City
Babol
Province
Mazandaran
Postal code
4714854168
Approval date
2022-07-05, 1401/04/14
Ethics committee reference number
IR.SSRC.REC.1401.040

Health conditions studied

1

Description of health condition studied
patellofemoral pain syndrome
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders

Primary outcomes

1

Description
Pain
Timepoint
Before the intervention and after 8 weeks of intervention
Method of measurement
Pain questionnaire of Visual Analogue scale (VAS)

Secondary outcomes

1

Description
Kinetic: Ground reaction force
Timepoint
Before the intervention and after 8 weeks of intervention
Method of measurement
Force plate

2

Description
Kinematic: pelvic drop
Timepoint
Before the intervention and after 8 weeks of intervention
Method of measurement
Three-dimensional (3D) motion analysis system

3

Description
Kinematic: hip adduction
Timepoint
Before the intervention and after 8 weeks of intervention
Method of measurement
Three-dimensional (3D) motion analysis system

4

Description
Kinematic: knee flexion
Timepoint
Before the intervention and after 8 weeks of intervention
Method of measurement
Three-dimensional (3D) motion analysis system

5

Description
Kinematic: knee valgus
Timepoint
Before the intervention and after 8 weeks of intervention
Method of measurement
Three-dimensional (3D) motion analysis system

6

Description
Kinematic: dorsiflexion
Timepoint
Before the intervention and after 8 weeks of intervention
Method of measurement
Three-dimensional (3D) motion analysis system

Intervention groups

1

Description
Intervention group: This group performs gait retraining with verbal feedback. gait retraining done on a treadmill. People run on a treadmill at all times at a convenient speed. Verbal feedback in the form of a recipe such as "Knee retention in the direction of the toes, reduced pelvic sagging and maintaining pelvic symmetry، Decreasing vertical acceleration ( is provided by the tester: a quiet and calm walking style).In general, the practice time starts in 15 minutes for the first session and 3 to 9 minutes per week is added to the time. While the time of gait retaining is reduced from 100% in the first 4 weeks to 25% in the last weeks and then removed. Exercises are followed 3 days a week for 8 weeks.
Category
Treatment - Other

2

Description
Intervention group: this group, After performing the retraining group's practices, performs the protocol of the eccentric exercises. the participants will do the exercises correctly، The intensity of the exercises will increase progressively each week, and at the beginning of each stage, the exercises will be performed in a simpler and smaller volume، Step by step, more difficult exercises and less large exercises will be more difficult in the next steps, respectively, with the progress and improvement of the performance of the training athlete. In general, the practice time is 90 minutes, which is done after warm up and gait retraining. exercises are followed 3 days a week for 8 weeks.
Category
Treatment - Other

3

Description
Control group: This group continues their special routine exercises.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kharzami University
Full name of responsible person
Elahe Omidvar
Street address
Kharazmi university., Hesari Ave., Mirdamad St.
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 2222 8001
Fax
Email
elahe.omidvar@khu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Kharazmi
Full name of responsible person
amir letafatkar
Street address
Kharazmi university., Hesari Ave., Mirdamad St.
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 2222 8001
Email
letafatkaramir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Kharazmi
Proportion provided by this source
100
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
The University of kharazmi
Full name of responsible person
Amir Letafatkar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports injuries and corrective exercises
Street address
Kharazmi university., Hesari Ave., Mirdamad St.
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 2222 8001
Email
letafatkaramir@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of kharazmi
Full name of responsible person
Malihe Hadadnezhad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports injuries and corrective exercises
Street address
Kharazmi university., Hesari Ave., Mirdamad St.
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 2222 8001
Email
malihehadadnezhad@khu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of kharazmi
Full name of responsible person
Elahe Omidvar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
sports injuries and corrective exercises
Street address
Kharazmi university., Hesari Ave., Mirdamad St.
City
Tehran
Province
Tehran
Postal code
1571914911
Phone
+98 21 2222 8001
Email
elahe.omidvar@khu.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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only data related to demographic information and consequences are shared.
When the data will become available and for how long
After printing the article / articles are arrogant from the study
To whom data/document is available
The data can be displayed and shared at the logical request of the Iranian Clinical Trials Registration Center, journals and academic researchers / researchers who are researching and conducting scientific activities in this field.
Under which criteria data/document could be used
Data analysis and the use of documentation can only be done on the condition that their results be included in the systematic review articles conducted by researchers and academic authors. Terms of registration for sending data and documents including: 1. Send an email ( preferably with valid academic addresses ) to one of the study researchers. 2. Brief and logical explanation of how to use data or documentation. 3. Ensure the registration of a systematic review study protocol that has given access to data or documentation.
From where data/document is obtainable
By requesting study researchers Elahe Omidvar Elahe.omidvar@khu.ac.ir Malihe Hadadnezhad Malihehadadnezhad@khu.ac.ir Amir Letafatkar Amir.letafatkar@khu.ac.ir
What processes are involved for a request to access data/document
The applicant can request details from the researchers within 7 to 10 days using the email sent by email.
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