Protocol summary

Summary
general aim of this study: comparing of patella taping and brace on the biomechanical and muscular parameters of the lower extremities in women with pfps onl the stance phase of running and also comparison of these parameters between healthy group as control group and pfps group without brace and tape. subjects: A total of 30 subjects participated in this trial study in control (healthy)and PFPS groups (n = 15 per group) . the healthy group does not receive any intervention. the patellofemoral pain syndrome group will asses immediately after three stages including: with brace , with tape and without any intervention that the order of these stages will be randomly. resting interval will be consider between three stages. Inclusion criteria: healthy subjects and patients with patellofemoral pain syndrome aged 20-40 years. Exclusion criteria: history of back and lower extremities surgery-history of serious knee trauma at recent 6 months or mild trauma at recent 2 months - use steroidal drugs- low back and sacroilliac pain, history of neurological , rheumatologic and musculoskeletal disease- regular exercises - age over 40 years - history of Physiotherapy treatment. Interventions:kinematic and kinetic variables of lower extremity, muscular activity of Gluteus medius, biceps femoris, vastus medialis ana lateralis in three dimensions in women with patellofemoral syndrome during stance phase of running with patella taping compare to brace. outcome of this study: this study will do for comparing mentioned variables between healthy group and patellofemoral group without any intervention and in the next stage for comparing two management methods includind taping and bracing in patellofemoral group that the results of this study can help physicians to prescribe effective treatment for patients with patellofemoral pain syndrome.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201407272851N3
Registration date: 2014-09-01, 1393/06/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-01, 1393/06/10
Registrant information
Name
Mohammad Taghipour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4641
Email address
taghipour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol university of medical sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of biomechanical and muscular parameters between patellofemoral taping and patella stabilizer brace methods in women with patellofemoral syndrom during the stance phase of running
Public title
The comparison between patellofemoral taping and patella stabilizer brace methods on patellofemoral syndrom
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: healthy subjects ; patients with patellofemoral pain syndrome; aged 20-40 years. Exclusion criteria: history of back and lower extremities surgery; history of serious knee trauma at recent 6 months or mild trauma at recent 2 months ; use steroidal drugs; low back and sacroilliac pain; history of neurological; rheumatologic and musculoskeletal disease; regular exercises; age over 40 years; history of Physiotherapy treatment
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
babol university of medical sciences
Street address
keshavarz blv.
City
babol
Postal code
47176-47745
Approval date
2014-07-08, 1393/04/17
Ethics committee reference number
4323

Health conditions studied

1

Description of health condition studied
patellofemoral pain syndrome
ICD-10 code
m 17.9
ICD-10 code description
Gonarthrosis, unspecified

Primary outcomes

1

Description
kinematic variables
Timepoint
before and after intervention
Method of measurement
motion analyzer cameras

2

Description
kinetic variables
Timepoint
before and after intervention
Method of measurement
force plate

3

Description
mucular variables
Timepoint
before and after intervention
Method of measurement
EMG

Secondary outcomes

empty

Intervention groups

1

Description
control group: without brace and tape
Category
Rehabilitation

2

Description
intervention group: with brace and immediately after patella brace, we will asses mentioned variables
Category
Rehabilitation

3

Description
intervention group: with tape and immediately after patella taping, we will asses mentioned variables
Category
Rehabilitation

4

Description
intervention group: without brace and tape
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Somayeh Hosseinzadeh
Street address
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Bijani
Street address
Keshavarz blv.
City
Babol
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Somayeh Hosseinzadeh
Position
PHD candidate
Other areas of specialty/work
Street address
Keshavarz Blv.
City
Babol
Postal code
Phone
+98 11 3225 2071
Fax
Email
hoseinzadeh87@yahooo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mohammad Taghipour
Position
PHD of Physiotherapy
Other areas of specialty/work
Street address
Keshavarz Blv.
City
Babol
Postal code
Phone
+98 11 3219 9595
Fax
Email
taghipourm@yahoo.com\taghipour@mubabol.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Somayeh Hosseinzadeh
Position
PHD candidate
Other areas of specialty/work
Street address
Keshavarz Blv.
City
Babol
Postal code
Phone
+98 11 3225 2071
Fax
Email
hoseinzadeh87@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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