the effect of subject specific Foot progression angle retraining on the kinetics, kinematic, muscle activation and functional ability during walking in patients with knee osteoarthritis.
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Recruitment centers
#1
Name of recruitment center - English: Baqiyatallah hospital
Name of recruitment center - Persian: بیمارستان بقیه الله
Full name of responsible person - English: Alireza jalali
Full name of responsible person - Persian: علیرضا جلالی
Street address - English: sheykh bahaee Ave, Mollasadra Ave, vanak squar
Street address - Persian: میدان ونک، خیابان ملاصدرا، بعد از خیابان شیخ بهایی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435915371
Phone: +98 21 8805 0436
Fax:
Email: torkamang@yahoo.com
Web page address: https://baq.bmsu.ac.ir
Name of recruitment center - English: Baqiyatallah hospital
Name of recruitment center - Persian: بیمارستان بقیه الله
Full name of responsible person - English: Noushin Bayat
Full name of responsible person - Persian: نوشین بیات
Street address - English: sheykh bahaee Ave, Mollasadra Ave, vanak squar
Street address - Persian: میدان ونک، خیابان ملاصدرا، بعد از خیابان شیخ بهایی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435915371
Phone: +98 21 8805 0436
Fax:
Email: torkamang@yahoo.com
Web page address: https://baq.bmsu.ac.ir
Name of recruitment center - English: Baqiyatallah hospital Name of recruitment center - Persian: بیمارستان بقیه الله Full name of responsible person - English: Alireza jalaliNoushin Bayat Full name of responsible person - Persian: علیرضا جلالینوشین بیات Street address - English: sheykh bahaee Ave, Mollasadra Ave, vanak squar Street address - Persian: میدان ونک، خیابان ملاصدرا، بعد از خیابان شیخ بهایی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1435915371 Phone: +98 21 8805 0436 Fax: Email: torkamang@yahoo.com Web page address: https://baq.bmsu.ac.ir
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Tarbiat modares university
Name of organization / entity - Persian: دانشگاه تربیت مدرس
Full name of responsible person - English: Giti Torkaman
Full name of responsible person - Persian: گیتی ترکمان
Street address - English: tarbiat modares university, nasr bridge, jalale ale ahmad Ave
Street address - Persian: جلال آل احمد، پل نصر، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14115-111
Phone: +98 21 8288 2013
Fax: +98 21 8288 3129
Email: pres@modares.ac.ir
Web page address: http://www.modares.ac.ir
contact.organization_id:
Name of organization / entity - English: Tarbiat modares university
Name of organization / entity - Persian: دانشگاه تربیت مدرس
Full name of responsible person - English: Yaghoub Fatholahi
Full name of responsible person - Persian: یعقوب فتح الهی
Street address - English: Tarbiat Modares University, Jalale Ale Ahmad Ave
Street address - Persian: جلال آل احمد، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713116
Phone: +98 21 8288 2009
Fax: +98 21 8800 6544
Email: pres@modares.ac.ir
Web page address: http://www.modares.ac.ir
contact.organization_id: Name of organization / entity - English: Tarbiat modares university Name of organization / entity - Persian: دانشگاه تربیت مدرس Full name of responsible person - English: Giti TorkamanYaghoub Fatholahi Full name of responsible person - Persian: گیتی ترکمانیعقوب فتح الهی Street address - English: tarbiat modares universityTarbiat Modares University, nasr bridge, jalale ale ahmadJalale Ale Ahmad Ave Street address - Persian: جلال آل احمد، پل نصر، دانشگاه تربیت مدرس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14115-1111411713116 Phone: +98 21 8288 20132009 Fax: +98 21 8288 31298800 6544 Email: pres@modares.ac.ir Web page address: http://www.modares.ac.ir
Protocol summary
Study aim
the effect of subject specific Foot progression angle retraining on the kinetics, kinematic, muscle activation and functional ability during walking in patients with knee osteoarthritis
Design
Two arm parallel group, a single blinded randomised control trial
Settings and conduct
place to do: tarbiat modares university
way to do:6-weak gait retraining and assessment of parameters before and after training
Participants/Inclusion and exclusion criteria
osteoarthritis patients with grade II & III according to Kellgren-Lawrence scale in one knee or, if bilateral, being mild in one side
Intervention groups
intervention group: gait retraining as subject specific Toe out or Toe in
control group: normal walking
Main outcome variables
knee joint moment, muscle activation, pain, functional activity,quality of life
General information
Reason for update
Acronym
FPA, TO, TI
IRCT registration information
IRCT registration number:IRCT20101017004952N8
Registration date:2019-10-09, 1398/07/17
Registration timing:prospective
Last update:2019-10-31, 1398/08/09
Update count:1
Registration date
2019-10-09, 1398/07/17
Registrant information
Name
Giti Torkaman
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4509
Email address
torkamg@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of subject specific Foot progression angle retraining on the kinetics, kinematic, muscle activation and functional ability during walking in patients with knee osteoarthritis.
Public title
the effect of subject specific Foot progression angle retraining in knee osteoarthritis.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Definite OA Grade II & III as defined by the Kellgren-Lawrence scale in one knee or, if bilateral, being mild in one side
BMI: Between 25 and 30
Ability to walk independently on an even surface without any assistive devices
Minimum age 45 and maximum 65 years old
Exclusion criteria:
History of intra-articular injections over the past 6 months (such as hyaluronic acid, hydrocortisone and PRP)
History of regular physical activity in the past 3 months (at least 2 or 3 times per week and at least half an hour each time
History of musculoskeletal disorders and lower extremity joint injuries affecting balance
Severe TI or TO (57/7 ± 5/7)
Pes Planus (Flat foot) (rigid and flexible), Pes cavus (High arch)
Any malalignment of lower extremity which is evident by observation (Varus angel > 5֯ and Valgus angel > 15֯)
History of knee and lower extremity surgery, severe muscle weakness in lower extremity, MMT lower than 3/5
History of neurological, vestibular, neuromuscular diseases (Diabetes and Neurapathy), chronic orthopedic disorders of the trunk and lower extremities (Rheumatoid Arthritis), visual impairments, inability to comprehend commands
Osteoporosis
Taking medications not prescribed by a Rheumatologist.
Unwillingness to participate in the study for any reason
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
blocking randomization using the sealed, opaque, and stapled envelopes by an independent person
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessment and data acquisition will be performed by an expert in the Movement Disorders Laboratory that is blinded about grouping and kind of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat modares university
Street address
Jalale ale ahmad., nasr bridge., chamran highway
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.MODARES.REC.1398.004
Health conditions studied
1
Description of health condition studied
knee osteoarthritis disease
ICD-10 code
M15.0
ICD-10 code description
Primary generalized (osteo)arthritis
Primary outcomes
1
Description
knee adduction moment
Timepoint
before and after six-week retraining
Method of measurement
motion analysis system, nexus software
2
Description
knee flexion moment
Timepoint
before and after six-week retraining
Method of measurement
motion analysis system, nexus software
3
Description
Muscle activation
Timepoint
before and after six-week retraining
Method of measurement
Electromyography
Secondary outcomes
1
Description
pain
Timepoint
before and after six-week retraining
Method of measurement
visual analog scale
2
Description
Quality of life
Timepoint
before and after six-week retraining
Method of measurement
SF-36 questionnaire and WOMAC
3
Description
functional activity
Timepoint
before and after six-week retraining
Method of measurement
8-walking test and Timed up and go test
Intervention groups
1
Description
Intervention group: gait retraining
Category
Rehabilitation
2
Description
Intervention group:change the walking pattern(Toe in or Toe out) on the basis the first session assessment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Therapeutic and research center of movement disorder
Full name of responsible person
Giti Torkaman
Street address
jalale ale ahmad., nasr bridge., chamran highway
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 2013
Fax
+98 21 8288 3129
Email
torkamang@yahoo.com
Web page address
https://www.modares.ac.ir
2
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Noushin Bayat
Street address
sheykh bahaee Ave, Mollasadra Ave, vanak squar
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
torkamang@yahoo.com
Web page address
https://baq.bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Yaghoub Fatholahi
Street address
Tarbiat Modares University, Jalale Ale Ahmad Ave
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Fax
+98 21 8800 6544
Email
pres@modares.ac.ir
Web page address
http://www.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat modares university
Proportion provided by this source
100
Public or private sector
Public
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
Tarbiat modares university
Full name of responsible person
Giti Torkaman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalale ale ahmad
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4509
Fax
+98 21 8800 6544
Email
torkamang@yahoo.com
Web page address
http://www.modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Dr Giti Torkaman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
jalale ale ahmad., nasr bridge., chamran highway
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 2013
Fax
+98 21 8288 3129
Email
torkamang@yahoo.com
Web page address
http://www.modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Samaneh gholami
Position
دانشجوی دکترای تخصص
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Jalale ale ahmad., nasr bridge., chamran highway
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 2013
Fax
+98 21 8288 3129
Email
samaneh_gh_65@yahoo.com
Web page address
http://www.modares.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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
demographic data, main variable and its consequences
When the data will become available and for how long